Latest news with #T2DM
Cision Canada
a day ago
- Health
- Cision Canada
Gan & Lee Pharmaceuticals Presented Multiple Results in Novel Diabetes Therapies at the American Diabetes Association's 85th Scientific Sessions
In a Phase 2a clinical trial, the GLP-1 RA bofanglutide injection demonstrated a favorable safety and tolerability profile after 23 weeks of once weekly treatment in patients with type 2 diabetes mellitus (T2DM), with significant HbA1c reductions alongside comprehensive benefits for body weight, blood pressure and blood lipid profiles. In a Phase 2b clinical trial, the bofanglutide injection showed superior HbA1c and body weight reduction than semaglutide (Ozempic ®) after 24 weeks of bi-weekly treatment in patients with T2DM, along with an acceptable safety and tolerability profile. In a Phase 2 clinical trial, the once-weekly insulin GZR4 injection demonstrated comparable efficacy and safety profiles in patients with T2DM after 16 weeks of treatment. Notably, GZR4 injection achieved superior HbA1c reduction in patients with inadequate glycemic control on prior basal insulin therapy compared to once-daily insulin degludec (Tresiba ®). BEIJING and BRIDGEWATER, N.J., June 21, 2025 /CNW/ -- Gan & Lee Pharmaceuticals (Gan & Lee, stock code: announced that the company presented multiple Phase 2 clinical study results of ultra-long-acting GLP-1 receptor agonist (GLP-1 RA) bofanglutide (research code: GZR18) injection and once-weekly basal insulin analog GZR4 injection during a poster presentation at the American Diabetes Association (ADA)'s 85th Scientific Sessions. Bofanglutide injection and GZR4 injection are investigational drugs that have not yet been launched in any country. Gan & Lee Pharmaceuticals does not recommend the use of any unapproved drugs/indications. Bofanglutide injection: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 2a Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of Bofanglutide (GZR18) Injection in Chinese Patients with Type 2 Diabetes Mellitus (T2DM) In this Phase 2a clinical trial (NCT06256523), 36 adults with T2DM who had inadequate glycemic control through diet and exercise and/or irregular use of antidiabetic medications, were randomized to receive either bofanglutide injection (N=27) or placebo (N=9) once weekly (QW) for 23 weeks, with a dose escalating from 1.5 mg to 13 mg. The key efficacy endpoint was HbA1c change from baseline to week 23. After 23 weeks of treatment, the mean HbA1c change from baseline in the bofanglutide groups was -1.81% compared to 0.12% in the placebo group, with an estimated treatment difference of -1.93% points *. The proportion of participants achieving an HbA1c target of <7.0% and ≤6.5% was 57.7% and 46.2%, respectively, compared to zero in the placebo group. In terms of weight management, participants treated with bofanglutide experienced a mean reduction in body weight of 6.92 kg from baseline, corresponding to a 9.3% decrease, compared to a minimal reduction of 1.2% in the placebo group. Furthermore, bofanglutide showed comprehensive improvements over placebo in multiple metabolic parameters, including fasting plasma glucose (FPG), glycated albumin (GA), waist circumference (WC), blood pressure, and lipid profiles. In terms of safety, bofanglutide was well tolerated in patients with T2DM. Consistent with known GLP-1 RAs, the most common adverse events were gastrointestinal-related, primarily observed during the early dose-escalation period with mostly mild to moderate in severity. No hypoglycemic events or investigational product-related serious adverse events were reported during the study. Bofanglutide injection: A Multicenter, Randomized, Open-label, Active comparator-controlled Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of bofanglutide Injection versus Semaglutide (Ozempic ®) in Chinese Patients with T2DM In this Phase 2b clinical trial (NCT06256549), a total of 272 eligible Chinese patients with T2DM, who had inadequate glycemic control either after lifestyle intervention or despite stable use of oral antidiabetic drugs (OADs) for at least 3 months, were randomized to receive bi-weekly (Q2W) 12 mg (N=55), 18 mg (N=54), 24 mg (N=55) bofanglutide injections, or once-weekly (QW) 24 mg (N=54) bofanglutide injections, or 1 mg semaglutide (Ozempic ®, N=54) for 24 weeks of treatment, including the dose-escalation period. The primary endpoint was HbA1c change from baseline to week 24. After 24 weeks of treatment, the mean reductions in HbA1c from baseline were 1.87%, 2.28%, and 1.94% in the bofanglutide groups at 12 mg, 18 mg, and 24 mg Q2W, respectively, and -2.32% in the 24 mg QW group. All these treatment regimens showed greater HbA1c reductions compared to the semaglutide group (-1.60%), with the 18 mg Q2W and 24 mg QW bofanglutide groups demonstrating statistically significant superiority (p<0.001) *. Among drug-naïve patients with inadequate glycemic control despite lifestyle interventions, the 18 mg Q2W bofanglutide group achieved a mean HbA1c reduction of 2.98%, which was significantly greater than that observed with semaglutide (-2.04%; p<0.001)*. The proportions of patients achieving HbA1c target of <7.0% were 63.0% to 73.6% in the Q2W bofanglutide group, 75.0% in the QW bofanglutide group, and 70.0% in the semaglutide group. For the HbA1c ≤6.5% target, the corresponding proportions were 58.2% to 67.9%, 69.2%, and 62.0%, respectively. Furthermore, the mean change in body weight for all bofanglutide groups from baseline to week 24 ranged from -4.26 to -6.54 kg, compared to -3.25 kg in the semaglutide group *. Bofanglutide also greatly improved FPG, blood pressure, lipid profiles, and other metabolic parameters. In this study, bofanglutide was g enerally well tolerated, with safety and tolerability consistent with other known GLP-1 RAs. The most common adverse events were gastrointestinal-related, mostly mild to moderate in severity, and no sever e hypoglycemic events were observed. GZR4 injection: A Multicenter, Randomized, Open-label, Active-controlled, Treat-to-target Phase 2 Clinical Study Comparing the Efficacy and Safety of GZR4 Injection Versus Insulin degludec (IDeg, Tresiba ®) in Chinese patients with T2DM This Phase 2 clinical study (NCT06202079) enrolled a total of 83 Chinese patients with T2DM who had inadequate glycemic control on OADs (Part A), and 96 patients with inadequate control on OADs combined with basal insulin therapy (Part B). Participants were randomized to receive QW GZR4 injection (Part A: N=42; Part B: N=41) or once-daily IDeg (Tresiba ®) injection (Part A: N=48; Part B: N=48) for 16 weeks of treatment. The primary efficacy endpoint was the change in HbA1c from baseline to week 16. After 16 weeks of treatment, in patients from Part A, the mean change in HbA1c was comparable between GZR4 groups and IDeg groups (−1.50% versus -1.48%, p = 0.90). The proportion of participants achieving HbA1c target of <7.0% was 59.5% in the GZR4 group and 70.7% in the IDeg group, while the proportion achieving HbA1c target of ≤6.5% was 38.1% and 29.3%, respectively. In patients from Part B, GZR4 demonstrated significantly greater HbA1c reduction compared to IDeg (-1.26% vs -0.87%; p<0.01), with a higher proportion of patients achieving HbA1c targets of <7.0% and ≤6.5% (52.1% vs 29.2%; 25.0% vs 10.4%). In addition, improvements from baseline in FPG and time in range (TIR) were comparable between the GZR4 group and IDeg group. GZR4 achieved effective glycemic control without the need for a loading dose at the first administration, while the total weekly insulin dosage (mole) for GZR4 was approximately 40–50% of that for IDeg (p<0.001). In terms of safety, the incidence of adverse events was similar between the two groups. No severe hypoglycemic events or investigational product-related serious adverse events were reported during the study. * The clinical data were presented as mean (SE) value. The detailed results of the above Phase 2 clinical study will be published in a peer-reviewed journal. Conclusion and Future Direction The latest clinical results presented at this year's ADA conference highlight Gan & Lee Pharmaceuticals' leading position in the development of long-acting antidiabetic therapies. Building on these positive outcomes, the company will continue to advance the research and development of innovative treatments for diabetes. Currently, Gan & Lee has initiated and is accelerating large-scale Phase 3 clinical programs in China for bofanglutide injection and GZR4 injections for the treatment of type 2 diabetes, aiming to provide more effective treatment options for patients with diabetes. Forward-looking statements Forward-looking statements are based on our expectations and assumptions as of the date of the statements. Actual results may differ materially from those expressed in these forward-looking statements due to a variety of factors, and we can give no assurance that such results will be achieved in the future. We undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. About Gan & Lee Gan & Lee Pharmaceuticals developed the first Chinese domestic insulin analog. Currently, Gan & Lee has six core insulin products, including five insulin analog varieties: long-acting glargine injection (Basalin ®), fast-acting lispro injection (Prandilin™), fast-acting aspart injection (Rapilin ®), mixed protamine zinc lispro injection (25R) (Prandilin™25), aspart 30 injection (Rapilin ® 30), and one human insulin injection - mixed protamine human insulin injection (30R) (Similin ® 30). The company has two approved medical devices in China, namely reusable insulin injection pen (GanleePen), and disposable pen needle (GanleeFine ®). In China's 2024 National Insulin-Specific Centralized Procurement, Gan & Lee Pharmaceuticals ranked first among all selected companies in terms of procurement demand for insulin analogs. The company is also making strides in international markets, with the disposable pen needle (GanleeFine ®) approved by the US Food and Drug Administration (FDA) in 2020 and received GMP inspection approval from the European Medicines Agency (EMA) in 2024. These achievements significantly boost Gan & Lee's competitiveness in both international and domestic markets. In the future, Gan & Lee will strive for comprehensive coverage in diabetes treatment. Moving forward with its mission to become a world-class pharmaceutical company, Gan & Lee will also actively develop new chemical entities and biological drugs, focusing on treatments for metabolic diseases, cardiovascular diseases, and other therapeutic areas.
Globe and Mail
5 days ago
- Business
- Globe and Mail
Diabetes Clinical Trials Analysis 2025: EMA, PDMA, FDA Approvals, Therapies, Medication, NDA Approval, IND, Mechanism of Action, Route of Administration by DelveInsight
Diabetes Companies are vTv Therapeutics, Tonghua Dongbao Pharmaceutical, Eli Lilly and Company, Celon Pharma, Sciwind Biosciences, AstraZeneca, Suzhou Alphamab Co., Ltd., Neurodon, Abarceo Pharma, Chong Kun Dang Pharmaceutical and others. (Albany, USA) DelveInsight's, ' Diabetes Pipeline Insight 2025 ' report provides comprehensive insights about 200+ companies and 200+ pipeline drugs in the Diabetes pipeline landscape. It covers the Diabetes pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Diabetes therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. Discover the latest drugs and treatment options in the Diabetes Pipeline. Dive into DelveInsight's comprehensive report today! @ Diabetes Pipeline Outlook Key Takeaways from the Diabetes Pipeline Report In April 2025, Gan & LEE Pharmaceuticals announced a study will be conducted to compare the efficacy, safety and patient-reported outcome of once-weekly GZR4 and once-daily Insulin Degludec with or without Non-Insulin Antidiabetic Agents in subjects with Type 2 Diabetes Mellitus (T2DM) treated with basal insulin. In March 2025, Dong-AST Co. Ltd announced a study is a multicenter, double-blind, active-controlled, randomized, parallel, phase IV clinical trial to evaluate the efficacy and safety of DA-2811 when added to ongoing metformin monotherapy in patients with type 2 diabetes who have inadequate glycemic control. In March 2025, Novo Nordisk A/S announced a study compares 2 medicines for type 1 and type 2 diabetes - faster aspart (a new medicine) and insulin aspart (a medicine doctors can already prescribe). Participants will either get faster aspart or insulin aspart (NovoRapid®) - which treatment is decided by chance. DelveInsight's Diabetes pipeline report depicts a robust space with 200+ active players working to develop 200+ pipeline therapies for Diabetes treatment. The leading Diabetes Companies such as vTv Therapeutics, Tonghua Dongbao Pharmaceutical, Eli Lilly and Company, Celon Pharma, Sciwind Biosciences, AstraZeneca, Suzhou Alphamab Co., Ltd., Neurodon, Abarceo Pharma, Chong Kun Dang Pharmaceutical and others. Promising Diabetes Therapies such as Aspirin, DA-2811, Forxiga, TG103, and others. Stay ahead with the most recent pipeline outlook for Diabetes. Get insights into clinical trials, emerging therapies, and leading companies with DelveInsight @ Diabetes Treatment Drugs Emerging Diabetes Drugs Profile Cadisegliatin: vTv Therapeutics Cadisegliatin, also known as TTP399, is an innovative oral medication developed by vTv Therapeutics, designed as a liver-selective glucokinase activator. It aims to serve as an adjunctive therapy to insulin for individuals with type 1 diabetes (T1D). This drug has been recognized for its potential to improve glycemic control by enhancing hepatic glucose uptake and glycogen storage independently of insulin, addressing a critical need in diabetes management. Currently, the drug is in the Phase III stage of its clinical trial for the treatment of Diabetes. LY-3209590: Eli Lilly and Company Insulin efsitora alfa (LY3209590) is a once-weekly basal insulin, a fusion protein that combines a novel single-chain variant of insulin with a human IgG2 Fc domain. It is specifically designed for once-weekly subcutaneous administration, and with its low peak-to-trough ratio, it has the potential to provide more stable glucose levels (less glucose variability) throughout the week. Efsitora is in phase III development for adults with type 1 and 2 diabetes. THDB0206: Tonghua Dongbao Pharmaceutical BC Lispro (THDB0206) is an ultra-rapid-acting insulin analog developed by Tonghua Dongbao Pharmaceutical Co., Ltd. for the treatment of Diabetes. BC Lispro is designed to restore early-phase insulin secretion, which is often impaired in diabetic patients. This insulin analog utilizes a new formulation technology that allows for rapid absorption and action, mimicking the physiological pattern of insulin secretion after meals. Such characteristics are expected to reduce the risk of late postprandial hypoglycemia, providing patients with greater flexibility in managing their insulin injections. Currently, the drug is in the Phase III stage of its clinical trial for the treatment of Diabetes. CPL207280: Celon Pharma CPL207280 is a novel G-protein-coupled receptor 40 (GPR40) agonist under development for the treatment of Diabetes. CPL207280 acts as an agonist for GPR40, a receptor that plays a crucial role in enhancing glucose-stimulated insulin secretion from pancreatic beta cells. This mechanism is particularly beneficial for T2D patients, as it can improve glycemic control without the risk of hypoglycemia, a common side effect associated with other diabetes medications. Currently, the drug is in the Phase II stage of development to treat Diabetes. XW014: Sciwind Biosciences XW014 is an oral small molecule glucagon-like peptide-1 (GLP-1) receptor agonist developed by Sciwind Biosciences for the treatment of obesity and Diabetes (T2D). XW014 functions as a GLP-1 receptor agonist, which means it mimics the action of the GLP-1 hormone that is released after meals. This hormone plays a key role in regulating glucose metabolism by stimulating insulin secretion, inhibiting glucagon release, and promoting satiety. As an oral small molecule, XW014 offers advantages over traditional peptide-based GLP-1 therapies, such as ease of administration and the potential for combination therapies with other oral medications. Currently, the drug is in Phase I stage of its clinical trial for the treatment of Diabetes. KN056: Suzhou Alphamab Co., Ltd. KN-056 is a glucagon-like peptide-1 receptor (GLP-1R) modulator developed by Suzhou Alphamab Co., Ltd. for the treatment of Diabetes. KN-056 functions as a GLP-1R modulator, which means it targets the glucagon-like peptide-1 receptor. GLP-1 is a hormone that plays a key role in regulating glucose metabolism by stimulating insulin secretion, inhibiting glucagon release, and promoting satiety. By modulating the GLP-1 receptor, KN-056 aims to improve glycemic control in patients with Diabetes. Currently, the drug is in the Phase I stage of its clinical trial for the treatment of Diabetes. The Diabetes Pipeline Report Provides Insights into The report provides detailed insights about companies that are developing therapies for the treatment of Diabetes with aggregate therapies developed by each company for the same. It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Diabetes Treatment. Diabetes Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects. Diabetes Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type. Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Diabetes market Explore groundbreaking therapies and clinical trials in the Diabetes Pipeline. Access DelveInsight's detailed report now! @ New Diabetes Drugs and Medication Diabetes Companies vTv Therapeutics, Tonghua Dongbao Pharmaceutical, Eli Lilly and Company, Celon Pharma, Sciwind Biosciences, AstraZeneca, Suzhou Alphamab Co., Ltd., Neurodon, Abarceo Pharma, Chong Kun Dang Pharmaceutical and others. The Diabetes pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as Oral Intravenous Subcutaneous Parenteral Topical Diabetes Products have been categorized under various Molecule types such as, Recombinant fusion proteins Small molecule Monoclonal antibody Peptide Polymer Gene therapy Unveil the future of Diabetes Treatment. Learn about new drugs, pipeline developments, and key companies with DelveInsight's expert analysis @ Diabetes Market Drivers and Barriers Scope of the Diabetes Pipeline Report Coverage- Global Diabetes Companies- vTv Therapeutics, Tonghua Dongbao Pharmaceutical, Eli Lilly and Company, Celon Pharma, Sciwind Biosciences, AstraZeneca, Suzhou Alphamab Co., Ltd., Neurodon, Abarceo Pharma, Chong Kun Dang Pharmaceutical and others. Diabetes Therapies- Aspirin, DA-2811, Forxiga, TG103, and others. Diabetes Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination Diabetes Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Get the latest on Diabetes Therapies and clinical trials. Download DelveInsight's in-depth pipeline report today! @ Diabetes Companies, Key Products and Unmet Needs Table of Content Introduction Executive Summary Diabetes: Overview Pipeline Therapeutics Therapeutic Assessment Diabetes– DelveInsight's Analytical Perspective Late Stage Products (Phase III) Cadisegliatin: vTv Therapeutics Drug profiles in the detailed report….. Mid-Stage Products (Phase II) CPL207280: Celon Pharma Drug profiles in the detailed report….. Early Stage Products (Phase I) KN056: Suzhou Alphamab Co., Ltd. Drug profiles in the detailed report….. Preclinical and Discovery Stage Products Drug name: Company name Drug profiles in the detailed report….. Inactive Products Diabetes Key Companies Diabetes Key Products Diabetes- Unmet Needs Diabetes- Market Drivers and Barriers Diabetes- Future Perspectives and Conclusion Diabetes Analyst Views Diabetes Key Companies Appendix About Us DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. Connect with us to get high-quality, accurate, and real-time intelligence to stay ahead of the growth curve. Media Contact Company Name: DelveInsight Business Research LLP Contact Person: Ankit Nigam Email: Send Email Phone: +19193216187 Address: 304 S. Jones Blvd #2432 City: Albany State: New York Country: United States Website:
India.com
14-06-2025
- Health
- India.com
How To Manage And Reduce The Risk Of Gestational Diabetes?
When a woman who was not previously diabetic develops high blood sugar levels during the second or third trimester of pregnancy, it is known as Gestational Diabetes Mellitus (GDM). If a woman aged 35 years or older has a history of Diabetes in their first degree relative like parents/siblings, has had Gestational Diabetes in a previous pregnancy, has delivered a large baby before, has Polycystic Ovarian Syndrome (PCOS), or has had multiple pregnancies. Also, certain ethnic groups, such as South Asians, and individuals with a sedentary lifestyle are also more prone to developing Gestational Diabetes during their pregnancy. Dr Farah Ingale, Senior Physician & Diabetologist, Director-Internal Medicine, Fortis Hiranandani Hospital Vashi shares how to manage and reduce the risk of gestational diabetes. GDM is mostly caused by hormonal changes happening in pregnancy that causes Insulin Resistance, genetic disposition can also be a cause for GDM. Classic symptoms of GDM include increased thirst, urination, fatiguability, wounds that do not heal, blurred vision, recurrent infections like of the urinary tract. Gestational Diabetes is diagnosed primarily through an Oral Glucose Tolerance Test (OGTT) and elevated blood sugar levels. Additional findings may include the presence of ketones in the urine, fetal macrosomia (a larger-than-average baby), or Polyhydramnios (excess amniotic fluid). GDM has long-term impact and complications that could impact both the foetus and the mother. If diagnosed with GDM. There is a 70 per cent risk of the mother developing Type 2 Diabetes Mellitus (T2DM), and certain metabolic syndromes and cardiovascular issues if GDM is left untreated. Children born to mothers with GDM also run the risk of developing T2DM as they grow older. They can also develop cognitive defects. GDM is also associated with increased risk of kidney disease and cancers. GDM can have a significant psychosocial impact due to the lifestyle and dietary restrictions an individual must follow. It may also lead to immediate and short-term complications for both the mother and the baby. Developing nations have been severely impacted by the growing burden of GDM. To tackle this silent crisis, we need to implement preventative strategies like lifestyle modifications and maintaining a normal weight by eating a healthy balanced diet and regular physical activity. Avoid being sedentary and remain stress free and also go for regular medical check-ups. Consult a doctor who can help make a diet chart for you depending on your body's needs. Consume foods with low Glycaemic Index (GI) as they release sugar into the blood stream slowly and do not lead to a sudden glucose spike. Foods that fall in that category are Quinoa, whole Wheat, Oats, brown Rice, Almonds, Walnuts, Flaxseeds, pulses. Practise portion control and abide by strict meal timings. For pregnant women, with a history of Diabetes or Obesity preconception counselling and testing is very important. Early detection and management can reduce the risk of adverse pregnancy outcomes. If necessary, insulin is the preferred medication for managing Gestational Diabetes. Maintaining good blood sugar control can significantly reduce or even prevent complications. Postpartum care is also a crucial aspect of overall management. --
Associated Press
26-04-2025
- Health
- Associated Press
HighTide Therapeutics to Showcase New Analyses of Phase 2 MASH/T2DM Studies of Berberine Ursodeoxycholate (HTD1801) and Pre-Clinical Results of Rimtoregtide (HTD4010) in Presentations at EASL Congress 2025
HONG KONG - April 25, 2025 ( NEWMEDIAWIRE ) – HighTide Therapeutics, Inc. ( a clinical stage biopharmaceutical company specializing in the development of multifunctional multi-targeted therapies for chronic liver and metabolic diseases, announced today that it will present at the EASL Congress 2025, taking place from May 7-10, 2025 in Amsterdam. The presentations include post-hoc analyses of two Phase 2 clinical studies of berberine ursodeoxycholate (HTD1801), a gut-liver anti-inflammatory metabolic modulator, being developed for treatment of metabolic dysfunction-associated steatohepatitis (MASH) and type 2 diabetes mellitus (T2DM). A third presentation will present preclinical results for rimtoregtide (HTD4010), a peptide derived from the Reg3a protein, in liver failure in mice. Effects of Berberine Ursodeoxycholate (HTD1801) in Patients with At-risk MASH and T2DM (Presentation SAT-440, Poster Presentation, May 10, 8:30 AM CET) About the Abstract: Due to the ongoing unmet medical need, clinical development in MASH focuses on patients who are at a higher risk of disease progression and outcomes due to the presence of moderate to advanced fibrosis (defined as at-risk MASH). The purpose of this analysis was to assess the effects of HTD1801 in patients with at-risk MASH and T2DM as defined by baseline MRI cT1>875 ms. Eighteen weeks of treatment with HTD1801 resulted in substantial improvements in key hepatic and cardiometabolic parameters in patients with at-risk MASH and compared to placebo, twice as many patients achieved a reduction in liver fat content (MRI-PDFF) or fibroinflammation (cT1) that have been associated with improvements in liver histology. These data are particularly insightful as HTD1801 continues to be evaluated in an ongoing paired biopsy study of patients with at-risk MASH and pre-diabetes or diabetes. Effects of Berberine Ursodeoxycholate (HTD1801) in Chinese Patients with T2DM and Presumed MASLD (Presentation SAT-432, Poster Presentation, May 10, 8:30 AM CET) About the Abstract: T2DM typically coexists with other metabolic abnormalities such as hyperlipidemia, obesity, and MASH that can exacerbate T2DM and can lead to a worse prognosis with increased risk for mortality and cardiovascular outcomes. In a Phase 2 study in patients with T2DM, HTD1801 achieved the primary endpoint with a significant decrease in HbA1c. Based on the latest diagnostic criteria, it is likely that a substantial subgroup of the study may have had concurrent metabolic dysfunction-associated steatotic liver disease (MASLD). The purpose of this analysis was to evaluate the benefits of HTD1801 in patients with T2DM and MASLD identified by baseline controlled attenuation parameter values >288 dB/M (correlated to 5% liver fat content). HTD1801 treatment demonstrated both dose-dependent improvements in cardiometabolic and hepatic parameters in patients with T2DM and MASLD. These data suggest HTD1801 can comprehensively address metabolic and cardiovascular risk factors beyond glycemic control. A Comparison of the Protective Effects of Rimtoregtide (HTD4010) and DUR-928 on Acute Liver Failure in Mice (Presentation FRI-141, Poster Presentation, May 9, 8:30 AM CET) About the Abstract: The purpose of this study was 1) to test the potential protective effects of HTD4010 in an LPS-induced model mimicking acute liver failure in mice and 2) compare these effects to DUR-928, which is currently in late-stage development for the treatment of alcohol-associated hepatitis. In an LPS-induced mouse model mimicking acute liver failure, HTD4010 resulted in significant improvement in survival rates (greater than 2-fold) compared to the model control. These protective effects of HTD4010 were significantly greater than DUR-928. These findings provide evidence that HTD4010 may have a beneficial effect on acute liver conditions including alcohol-associated hepatitis and other acute-inflammatory-related conditions. About Berberine Ursodeoxycholate Berberine ursodeoxycholate (HTD1801) is an orally delivered, gut-liver anti-inflammatory metabolic modulator being developed for the treatment of metabolic and digestive diseases. HTD1801, an ionic salt of berberine and ursodeoxycholate, is a new molecular entity with a unique dual mechanism of action: AMP kinase activation and NLRP3 inflammasome inhibition. These two key mechanistic pathways have been associated with improvements in insulin resistance, glucose metabolism, lipid metabolism, and hepatic inflammation, potentially providing a comprehensive treatment platform for the multifaceted nature of complex metabolic diseases. HTD1801 is being developed for multiple indications. HTD1801 met the primary endpoint in two Phase 3 clinical trials in patients with type 2 diabetes mellitus (T2DM), demonstrating a clinically meaningful effect on HbA1c. In both trials, key secondary endpoints were achieved, suggesting multiple advantages of HTD1801 including improvement in cardiometabolic risk indicators. In addition to T2DM, HTD1801 efficacy in treating metabolic dysfunction-associated steatohepatitis (MASH) has been demonstrated in a Phase 2a clinical trial, and a global multicenter Phase 2b trial assessing the histologic benefit of HTD1801 is currently ongoing, with topline results expected in 2025. About Rimtoregtide Rimtoregtide (HTD4010) is a clinical-stage compound in development for acute inflammatory-related indications including alcoholic hepatitis (AH). It is a peptide derived from the Reg3a protein with immunomodulatory, anti-inflammatory, and anti-apoptotic effects. HTD4010 has been evaluated in animal models of acute pancreatitis and acute liver failure, where protective effects were observed. A completed Phase 1 clinical trial of HTD4010 in healthy subjects demonstrated a favorable safety profile. AH is caused by chronic heavy alcohol abuse or a sudden, drastic increase in alcohol consumption. It is characterized by severe inflammation and, ultimately, liver failure and death. There is currently no approved treatment for AH and only a few drug candidates are in clinical development. The current standard of care focuses on symptom management, including abstinence, treating inflammation and providing nutrition. About HighTide Therapeutics HighTide Therapeutics, Inc. (Stock Code: is a globally integrated biopharmaceutical company focusing on the discovery and development of first-in-class multifunctional, multi-targeted therapies with poly-indication potential across metabolic diseases with significant unmet medical needs. HighTide is currently developing several clinical assets and associated global intellectual property rights, and advancing multiple mid-to-late-stage clinical trials including therapies for metabolic dysfunction-associated steatohepatitis (MASH), type 2 diabetes mellitus (T2DM), severe hypertriglyceridemia (SHTG) and primary sclerosing cholangitis (PSC). Berberine ursodeoxycholate (HTD1801), HighTide's lead drug candidate, received Fast Track designation from the United States Food and Drug Administration for both MASH and PSC and Orphan Drug designation for PSC. HTD1801 has been included in the National Major New Drug Innovation Program under the 13th Five-Year Plan for Major Technology Project in China. For more information, please visit Contact: [email protected]
Associated Press
15-04-2025
- Business
- Associated Press
Berberine Ursodeoxycholate (HTD1801) Consistently Demonstrates Comprehensive Benefits for Patients With Type 2 Diabetes Mellitus, Approaching NDA
HighTide Therapeutics Announces HTD1801 Meets the Primary Endpoints in Two Phase 3 Clinical Trials in Patients with Type 2 Diabetes Mellitus HONG KONG - April 15, 2025 ( NEWMEDIAWIRE ) - HighTide Therapeutics, Inc. ( a clinical-stage biopharmaceutical company specializing in the development of multifunctional, multi-targeted therapies for chronic liver and metabolic diseases, today announced that two Phase 3 trials (SYMPHONY 1 and SYMPHONY 2) of berberine ursodeoxycholate (HTD1801) in Chinese patients with type 2 diabetes mellitus (T2DM) met their primary endpoints and gated secondary endpoints. The results of these two Phase 3 clinical trials provide robust evidence that HTD1801 delivers comprehensive benefits for patients with T2DM. Based on these highly positive read-outs, HighTide plans to submit a new drug application (NDA) for HTD1801 as a treatment for T2DM to the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) later this year. SYMPHONY 1 (NCT06350890) and SYMPHONY 2 (NCT06353347) are randomized, double-blind, placebo-controlled, Phase 3 clinical trials designed to evaluate the efficacy and safety of HTD1801 in adults with T2DM and inadequate glycemic control despite using diet and exercise (SYMPHONY 1; N=407) or Metformin (SYMPHONY 2; N=549). The primary endpoint in both studies was the change in HbA1c from baseline with HTD1801 compared to placebo after 24 weeks of treatment. Gated secondary endpoints included the percentage of subjects achieving HbA1c <7.0%, change in fasting plasma glucose (FPG), low-density lipoprotein cholesterol (LDL-C), glutamyl transpeptidase (GGT), and high-sensitivity C-reactive protein (hs-CRP). The primary endpoint was achieved in both trials, showing a clinically meaningful, consistent glucose-lowering effect of HTD1801 SYMPHONY 1 (HTD1801 as monotherapy): At week 24, the reduction from baseline in HbA1c with HTD1801 (-1.3%) was superior to placebo. Further, those with more severe disease had a greater decrease with HTD1801: reduction in HbA1c was -1.5% for those with a baseline HbA1c ≥8.5%. SYMPHONY 2 (HTD1801 as an add-on therapy to Metformin): At week 24, the reduction from baseline in HbA1c with HTD1801 (-1.2%) was superior to placebo. Further, those with more severe disease had a more significant decrease with HTD1801: reduction in HbA1c was -1.6% for those with a baseline HbA1c ≥8.5%. In both Phase 3 trials, the efficacy on HbA1c reduction in patients treated with HTD1801 was sustained through week 24. In both trials, gated secondary endpoints were achieved, suggesting multiple advantages of HTD1801 beyond glucose-lowering including improvement in cardiometabolic risk indicators At week 24, in both studies, the proportion of patients who achieved HbA1c <7.0% was significantly higher in the HTD1801 treatment groups compared to placebo. Improvements in HbA1c with HTD1801 were parallelled with significant improvements in postprandial and fasting plasma glucose compared with placebo. In addition, HTD1801 demonstrated lipid-lowering effects, including significant reductions in low-density lipoprotein cholesterol (LDL-C) and non-high-density lipoprotein cholesterol (non-HDL-C). Moreover, HTD1801 treatment led to reductions in key inflammatory biomarkers - glutamyl transpeptidase (GGT) and high-sensitivity C-reactive protein (hs-CRP) - both of which are associated with cardiovascular risk in patients with T2DM. Favorable safety and tolerability profile Overall, safety and tolerability were favorable and consistent with previous clinical trials of HTD1801. The most commonly reported adverse events were gastrointestinal. In both studies <2% of patients discontinued early due to an adverse event. The incidence of hypoglycemia was low, with no severe hypoglycemia events reported. 'The encouraging results from these studies suggest that HTD1801 may offer a novel and improved therapeutic option for patients with T2DM,' said Dr. Linong Ji, the leading principal investigator for the two Phase 3 clinical trials and former Vice President of the International Diabetes Federation (IDF), Director of the Peking University Diabetes Center and Director of the Department of Endocrinology and Metabolism, Peking University People's Hospital. 'As an innovative drug candidate, HTD1801 exhibits a unique dual mechanism of action - AMP kinase activation and NLRP3 inflammasome inhibition - that is distinct from any existing T2DM drugs on the market. It is an oral therapy designed to deliver comprehensive clinical benefits - not only lowering blood glucose but also improving lipid metabolism and exerting anti-inflammatory effects - thereby potentially reducing diabetes-related complications and addressing significant unmet clinical needs. With continued clinical exploration, HTD1801 is expected to further expand its application to benefit patients globally. In today's pharmaceutical landscape, investment has become heavily concentrated on GLP-1-based drug development. While GLP-1 therapies hold significant clinical value, they do not adequately address the full spectrum of pathophysiological mechanisms underlying T2DM. To truly meet the multifaceted needs of T2DM management, continued innovation across a diverse range of therapeutic targets remains essential.' 'We extend our deepest gratitude to the patients who participated in these pivotal trials,' said Dr. Liping Liu, HighTide's founder and CEO. 'HTD1801's innovative dual-action approach – targeting both metabolic regulation and inhibiting inflammation – represents a potential breakthrough in diabetes treatment. We look forward to sharing data from the 28-week open-label extension of these studies and a Phase 3 head-to-head comparison with the dapagliflozin; we will continue to explore the clinical potential of HTD1801 to provide patients with chronic metabolic diseases a comprehensive treatment solution.' About Type 2 Diabetes Mellitus (T2DM) According to the International Diabetes Federation (IDF), 537 million adults (ages 20-79) were living with diabetes in 2021, and this number is projected to grow to 783 million (representing 1 in 8 adults) by 2045, of these, around 90% are T2DM cases. China has the largest population of diabetes patients worldwide, estimated to be 141 million in 2021, and projected to grow to 174 million in 2045. Diabetes is a global societal burden leading to over 6 million deaths per year. To address this urgent challenge, there is a critical need for innovative therapies that can deliver comprehensive clinical benefits for patients worldwide. About Berberine Ursodeoxycholate (HTD1801) Berberine ursodeoxycholate (HTD1801) is an orally delivered, gut-liver anti-inflammatory metabolic modulator being developed for the treatment of metabolic and digestive diseases. HTD1801, an ionic salt of berberine and ursodeoxycholate, is a new molecular entity with a unique dual mechanism of action: AMP kinase activation and NLRP3 inflammasome inhibition. These two key mechanistic pathways have been associated with improvements in insulin resistance, glucose metabolism, lipid metabolism, and hepatic inflammation, potentially providing a comprehensive treatment platform for the multifaceted nature of complex metabolic diseases. HTD1801 is being developed for multiple indications. In addition to T2DM, its efficacy in treating metabolic dysfunction-associated steatohepatitis (MASH) has been demonstrated in a Phase 2a clinical trial and a global multicenter Phase 2b trial assessing the histologic benefit of HTD1801 is currently ongoing, with topline results expected in 2025. About HighTide Therapeutics HighTide Therapeutics, Inc. (Stock Code: is a globally integrated biopharmaceutical company focusing on the discovery and development of first-in-class multifunctional, multi-targeted therapies with poly-indication potential across chronic liver and metabolic diseases with significant unmet medical needs. HighTide is currently developing several clinical assets and associated global intellectual property rights, and advancing multiple mid-to-late-stage clinical trials including therapies for metabolic dysfunction-associated steatohepatitis (MASH), type 2 diabetes mellitus (T2DM), severe hypertriglyceridemia (SHTG) and primary sclerosing cholangitis (PSC). Berberine ursodeoxycholate (HTD1801), HighTide's lead drug candidate, received Fast Track designation from the United States Food and Drug Administration for both MASH and PSC and Orphan Drug designation for PSC. HTD1801 has been included in the National Major New Drug Innovation Program under the 13th Five-Year Plan for Major Technology Project in China. For more information, please visit Contact: [email protected] View the original release on
