Latest news with #ClinicalTrialsArena
Yahoo
5 days ago
- Business
- Yahoo
J&J reports results from antibody combo trial for MM patients
Johnson & Johnson (J&J) has reported new outcomes from the Phase II RedirecTT-1 trial of bispecific antibodies, Talvey (talquetamab-tgvs) and Tecvayli (teclistamab-cqyv) for relapsed/refractory multiple myeloma (r/r MM). The data showed a high overall response rate (ORR) with durability in those who have triple-class-exposed (TCE) RRMM with true extramedullary disease (EMD). In the trial, which enrolled 90 subjects, the investigational combo resulted in an ORR of 78.9%, with over half of the subjects achieving a complete response or better, representing a significant improvement over the average ORR of less than 40% for this patient group. Notably, responses were also found to be high among those previously treated with B-cell maturation antigen (BCMA) CAR-T or anti-FcRH5 bispecific antibodies. According to the company, subjects in the trial showed deep and durable responses, with 66.2% remaining in response at the data cutoff and a median follow-up of 13.4 months. At one year, 61% of subjects were progression-free and alive, and 74.5% were alive, with median overall survival not yet reached. The combo was found to be consistent with prior reports of them as single agents. Subjects had the option to switch to once-a-month dosing, which might have contributed to better tolerability. The reports of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) were found to be mostly low grade. The study's findings were featured at the 2025 European Hematology Association Congress. EMD represents a severe form of MM, where myeloma cells form tumours in soft tissues and organs. Johnson & Johnson innovative medicine multiple myeloma disease area leader and vice-president Jordan Schecter said: 'Patients with extramedullary myeloma, especially those who have exhausted prior therapies, need more effective treatment options. 'Our first-in-class bispecific antibodies, Talvey and Tecvayli, have transformed treatment for relapsed or refractory multiple myeloma.' Recently, J&J reported that Tremfya decreased the symptoms and signs of active psoriatic arthritis (PsA) at 24 weeks in individuals against a placebo in the Phase IIIb APEX trial. "J&J reports results from antibody combo trial for MM patients" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
Yahoo
5 days ago
- Health
- Yahoo
Astria shares initial outcomes from ongoing trial of navenibart for HAE
Astria Therapeutics has reported encouraging initial outcomes from its ongoing ALPHA-SOLAR trial of monoclonal antibody inhibitor of plasma kallikrein, navenibart (STAR-0215), in patients with hereditary angioedema (HAE). The long-term, open-label study is designed to evaluate the safety and efficacy of the antibody in adult patients with HAE Type 1 or 2. According to the company, the study has revealed an overall decrease in the monthly attack rate, strengthening the evidence for the antibody's favourable tolerability and safety profile and its potential for every three-month (Q3M) and every six-month (Q6M) dosing regimens. The Q3M arm of the trial showed a 95% mean decrease in the monthly attack rate, while the Q6M arm showed an 86% reduction. All 16 target enrolment subjects from the Phase Ib/II ALPHA-STAR study elected for enrolling in the ALPHA-SOLAR trial. Subjects from Cohorts 1 and 2 of ALPHA-STAR were enrolled in Arm A, and those from Cohort 3 in Arm B. Astria noted that the antibody has shown a 50% overall attack freedom over a six-month period. The trial participants have remained in the ALPHA-SOLAR study, with the antibody being well-tolerated without any serious or severe treatment-emergent adverse events (TEAEs) and discontinuations. The antibody's safety profile in HAE patients was found to be favourable, with more than 17 months of cumulative follow-up since the commencement of the antibody in the ALPHA-STAR trial. Astria Therapeutics chief medical officer Christopher Morabito said: 'We are thrilled to share positive initial results from the ALPHA-SOLAR long-term open-label trial. Results are consistent with navenibart's best-in-class profile that we saw in the ALPHA-STAR Phase Ib/II trial. 'With now 12 to 18 months on navenibart, these ALPHA-SOLAR results support navenibart's favourable profile and the potential to administer navenibart every three and every six months.' In February this year, the company began the randomised Phase III ALPHA-ORBIT trial assessing navenibart to treat HAE. "Astria shares initial outcomes from ongoing trial of navenibart for HAE" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
13-06-2025
- Business
- Yahoo
Novo Nordisk ramps up obesity fight, advances amycretin to Phase III
Novo Nordisk is progressing both subcutaneous and oral versions of amycretin into Phase III trials for patients with obesity and who are overweight. Following a positive end-of-Phase II meeting, Novo Nordisk shared that regulatory authorities have approved the therapy to proceed. The company plans to initiate the trial in adults who are overweight or with obesity in Q1 2026. Executive vice president for development at Novo Nordisk, Martin Lange said: 'We are very pleased that the feedback from regulatory authorities has allowed us to take subcutaneous and oral amycretin in weight management to Phase III. We are excited about the amycretin molecule, and this marks an important step forward. We look forward to sharing more information on the design of the Phase III programme.' In a Phase Ib/IIa study (NCT06064006), amycretin, a glucagon-like peptide-1 (GLP-1) and amylin receptor co-agonist, showed weight-loss outcomes of up to 22% in 36 weeks. This was higher than seen by the company's blockbuster therapy Wegovy (semaglutide), which demonstrated a body weight change of 14% at week 36 in a Phase II study. The Phase Ia/IIb study investigated three doses of once-weekly subcutaneous amycretin in 125 patients who are overweight or with obesity. The primary endpoint was treatment-emergent adverse events (TEAEs), with Novo Nordisk reporting that the most common events were gastrointestinal, and the majority were mild to moderate in severity. If successful in a Phase III trial, GlobalData anticipates that amycretin will receive approval for adults with overweight or obesity in Q4 2030 in the US, followed by approval in the EU in Q1 2031. GlobalData is the parent company of Clinical Trials Arena. Novo Nordisk has signed a $812m partnership with Deep Apple Therapeutics to access novel compounds, not GLP-1RAs, for obesity and other diseases. As well as this, the company has also listed two new studies for CagriSema, another candidate in its pipeline. The company recently announced underwhelming data from a Phase III trial, which, while meeting its primary endpoint, fell short of the 25% weight loss promise. Following all these updates, Novo Nordisk's share price has now increased, making it the most valuable company in Europe once again. It has a market cap of $359.28bn compared to German software company SAP at $359bn. Novo Nordisk's flagship semaglutide, marketed as Wegovy in weight loss and Ozempic in type 2 diabetes, is forecast to make $49bn in sales in 2030, according to GlobalData. Its main competitor, Eli Lilly's tirzepatide, marketed as Zepbound in weight loss and Mounjaro in type 2 diabetes, is projected to reach sales of $60.8bn. Lilly's drug proved to have higher efficacy than Novo Nordisk's in a head-to-head study between the pair. "Novo Nordisk ramps up obesity fight, advances amycretin to Phase III" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
11-06-2025
- Business
- Yahoo
Medable launches programme to enhance eCOA build capabilities in clinical trials
US-based clinical technology provider Medable has launched a programme to supply contract research organisations (CROs) with generative AI-driven, electronic clinical outcome assessment (eCOA) build capabilities in digitally enabled studies. The Partner Program runs on the company's platform and aims to enable CROs to reduce clinical trial timelines by at least 50%, providing both administrative and financial benefits. It is also designed to help CROs generate trial-specific quotes rapidly and enter trial kick-off or bid defence meetings with pre-built digital studies. The Partner Program offers CROs a choice between self-service, managed service, or a hybrid support model, with the aim to deliver higher margin services through the use of generative AI. Among the programme's features are tools for pricing, demo support for bid defence meetings, and a content library to facilitate reuse and scalability. One of its key components is access to Studio, Medable's AI-powered tool for creating, storing and reusing eCOA instruments. Studio is designed to allow CROs to build eCOA assessments and deploy trials independently, providing the flexibility they need to scale their operations. Its features include content libraries, a translational workbench, virtual scheduling capabilities, and an AI-based point-and-click builder. Medable chief customer officer Alison Holland said: 'We have created a better buyer experience for CROs while putting powerful generative AI capabilities into their hands to reduce the time to first-patient-in and ensure greater control over the trial build process. 'Medable's Partner Program also simplifies administration and delivers strategic business advantages. Sponsors will want to work with our partners to move closer to Medable's vision of a one-day study start.' Based in California, Medable offers a digital clinical trials platform that has been used in nearly 400 trials across 70 countries to date. The company recently launched a digital-first long-term follow-up model intended to reduce burdens on sites and participants in cell and gene therapy trials. "Medable launches programme to enhance eCOA build capabilities in clinical trials" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
Yahoo
05-06-2025
- Business
- Yahoo
Enrolment concludes in Halia's Phase IIa trial of HT-6184 for MDS
Halia Therapeutics has completed the enrolment in its Phase IIa trial of HT-6184 (Ofirnoflast) in those with lower-risk myelodysplastic syndrome (MDS). The two-stage trial is designed to test the therapy in individuals who are intolerant of, refractory to, or ineligible for erythropoiesis-stimulating agents (ESA). It will assess the safety, biomarker response, and efficacy of this allosteric modulator of NEK7, targeting a key inflammatory pathway associated with bone marrow dysfunction in MDS. The trial has enrolled 18 subjects in stage I and an additional 15 in stage II. It includes a 16-week treatment duration, with a continuation phase based on patient response followed. Those who respond might continue therapy, while those who did not, with > 30% reduction in variant allele frequency clone size, could receive further treatment either as a single agent or in conjunction with previous ESA therapy for 16 extra weeks. The main objectives of the study are to assess efficacy via haematological improvement, VAF reduction, clonal suppression, safety, biomarker changes, quality of life, and patient tolerance. Halia noted that an interim analysis after stage I has been conducted, and topline outcomes are anticipated later in the year. Halia Therapeutics CEO Dr David Bearss said: 'Completing enrolment in our Phase IIa MDS study is a major milestone as we continue to validate our mechanism of action targeting innate immune dysregulation. 'This study provides important proof-of-concept data to support the therapeutic potential of HT-6184 in reducing clonal inflammation and improving haematologic outcomes for patients with symptomatic anaemia.' Halia focuses on developing therapies that help restore immune balance in neurodegenerative and inflammatory conditions. Its pipeline also includes HT-6184 plus semaglutide for a planned Phase IIa trial in obesity and Type 2 diabetes, anticipated to start in the third quarter of this year, and HT-4253 for neuroinflammation, currently in a Phase I trial. The company began the Phase II trial last year to investigate HT-6184 in managing post-procedural inflammatory and pain responses. "Enrolment concludes in Halia's Phase IIa trial of HT-6184 for MDS" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
