Latest news with #SumitomoPharma


Business Wire
3 days ago
- Health
- Business Wire
Poxel SA: New Scientific Presentations by Key Opinion Leaders to Further Highlight the Therapeutic Potential of Imeglimin at ADA 2025, the Leading Diabetes Conference
LYON, France--(BUSINESS WIRE)--Regulatory News: POXEL SA (Euronext : POXEL - FR0012432516), a clinical stage biopharmaceutical company developing innovative treatments for chronic serious diseases with metabolic pathophysiology, including Metabolic dysfunction-Associated SteatoHepatitis (MASH) and rare metabolic disorders, today announces that five presentations in relation to the potential of Imeglimin, marketed under the brand name TWYMEEG ® in Japan, will be made at the 85 th Scientific Sessions of the American Diabetes Associations, from June 20 to 23, 2025, in Chicago, Illinois (U.S.A). A total of 5 publications, including results from 2 clinical trials and 3 non-clinical studies supported by Sumitomo Pharma, will be delivered by leading Japanese diabetes experts. Main topics include: Potential of Imeglimin to Improve Inflammation and Fibrosis in Diabetic Kidney Disease, by Yoshimi Muta, from Fukuoka University (Fukuoka, Japan) The Efficacy of Imeglimin and Metformin on Insulin Sensitivity and Secretion Using Oral Minimal Model, by Ryota Usui, from Kansai Electric Power Hospital (Osaka, Japan) Attempts to Identify Predictors of Glycemic Control with Imeglimin—Machine Learning Analysis Using Clinical Trial Data, by Katsuhiko Hagi, from Sumitomo Pharma Therapeutic Potential of Imeglimin for Diabetic Neuropathy—Neuroprotective Effects in Type 1 Diabetic Rats, by Wataru Nihei, from the Aichi Gakuin University School of Pharmacy's Laboratory of Medicine (Nagoya, Japan) Effect of Imeglimin on Periodontitis in Streptozotocin-Induced Diabetic Rats, by Shun Kondo, from the Aichi Gakuin University's School of Dentistry (Nagoya, Japan) Thomas Kuhn, CEO of Poxel, stated: 'We are very pleased to see that the potential of Imeglimin (TWYMEEG ®) in the fight against type 2 diabetes and its associated conditions continues to generate enthusiasm within the scientific community, with the support of our partner Sumitomo Pharma. The presentations on TWYMEEG ®, at the world's most important academic event on diabetes provide further confirmation of its value as a treatment for diabetic patients.' About Poxel SA Poxel is a clinical stage biopharmaceutical company developing innovative treatments for chronic serious diseases with metabolic pathophysiology, including metabolic dysfunction-associated steatohepatitis (MASH) and rare disorders. For the treatment of MASH, PXL065 (deuterium-stabilized R -pioglitazone) met its primary endpoint in a streamlined Phase 2 trial (DESTINY-1). In rare diseases, development of PXL770, a first-in-class direct adenosine monophosphate-activated protein kinase (AMPK) activator, is focused on the treatment of adrenoleukodystrophy (ALD) and autosomal dominant polycystic kidney disease (ADPKD). TWYMEEG ® (Imeglimin), Poxel's first-in-class product that targets mitochondrial dysfunction, is now marketed for the treatment of type 2 diabetes in Japan by Sumitomo Pharma and Poxel expects to receive royalties and sales-based payments. Poxel has a strategic partnership with Sumitomo Pharma for Imeglimin in Japan. Listed on Euronext Paris, Poxel is headquartered in Lyon, France, and has subsidiaries in Boston, MA, and Tokyo, Japan. For more information, please visit: All statements other than statements of historical fact included in this press release about future events are subject to (i) change without notice and (ii) factors beyond the Company's control. These statements may include, without limitation, any statements preceded by, followed by or including words such as 'target,' 'believe,' 'expect,' 'aim,' 'intend,' 'may,' 'anticipate,' 'estimate,' 'plan,' 'project,' 'will,' 'can have,' 'likely,' 'should,' 'would,' 'could' and other words and terms of similar meaning or the negative thereof. Forward-looking statements are subject to inherent risks and uncertainties beyond the Company's control that could cause the Company's actual results or performance to be materially different from the expected results or performance expressed or implied by such forward-looking statements. The Company does not endorse or is not otherwise responsible for the content of external hyperlinks referred to in this press release.


Business Recorder
4 days ago
- Business
- Business Recorder
Japan's Nikkei retreats from 4-month high as threat of US involvement in Iran conflict looms
TOKYO: Japan's Nikkei share average retreated from a four-month high on Thursday as the threat of war between the United States and Iran dampened demand for higher-yielding assets. The Nikkei 225 Index slid 0.8%, snapping a three-day rise that lifted the gauge to the highest since February 20. The broader Topix lost 0.6%. The Israel-Iran conflict entered its seventh day, and President Donald Trump was ambiguous about whether the US would join in bombardment of Iran's nuclear sites. 'Heightened tensions in the Middle East continue to cool investor sentiment, with the downside appearing to widen,' said Nomura strategist Fumika Shimizu. Japan's Nikkei climbs for fourth day on US-China trade framework; Hino plunges There were 48 advancers on the Nikkei against 175 decliners. The biggest losers were Taiyo Yuden, down 3.1%, followed by Sumitomo Pharma, which lost 3%. The largest gainer was Nippon Steel Corp, surging 4.3% after it completed its long-simmering $14.9 billion acquisition of US Steel.


Time of India
10-06-2025
- Business
- Time of India
Japan's Nikkei rises for third session as government backs debt market
Japan's Nikkei share average extended its rally to a third session on Tuesday, lifted by news that the government is exploring a potential buyback of long-dated bonds to stabilise the market and contain rising yields. Tired of too many ads? Remove Ads Tired of too many ads? Remove Ads Japan's Nikkei share average extended its rally to a third session on Tuesday, lifted by news that the government is exploring a potential buyback of long-dated bonds to stabilise the market and contain rising Nikkei 225 Index closed 0.3% higher, trimming an earlier advance of 1.1%. The broader Topix ended shares have increasingly moved in tandem with Japanese government bonds (JGBs) amid rising concerns over the country's fiscal health and borrowing Minister Katsunobu Kato said the government will work to ensure confidence in the JGB market, a day after Reuters reported the finance ministry was considering buying back some super-long-dated bonds after a recent surge in yields."We see lower interest rates and a stable dollar-yen exchange rate as supporting the Japanese stock market today," said Maki Sawada, an equities strategist at Nomura were 133 advancers on the Nikkei against 87 decliners. Shares pared gains in the afternoon as the yen strengthened, sapping demand for export-reliant largest percentage gainers on the index were Sumitomo Pharma, which jumped 8.8%, followed by cosmetics giant Shiseido, gaining 6.3%.Tokyo Gas, down 3.8%, and Mitsui Mining and Smelting Co, down 2.9%, were the biggest startup ispace, which saw its second moon lander crash into the lunar surface last week, rebounded 10.3% after falling by their daily limit for two straight sessions.
Yahoo
28-05-2025
- Business
- Yahoo
New Clinical and Scientific Data on TWYMEEG® to be Presented at the 68th Annual Meeting of the Japan Diabetes Society
LYON, France, May 28, 2025--(BUSINESS WIRE)--Regulatory News: POXEL SA (Euronext : POXEL - FR0012432516), a clinical stage biopharmaceutical company developing innovative treatments for chronic serious diseases with metabolic pathophysiology, including metabolic dysfunction-associated steatohepatitis (MASH) and rare metabolic disorders, today announces that new clinical and scientific data on TWYMEEG® will be presented at the 68th Annual Meeting of the Japan Diabetes Society (JDS 2025), taking place from May 29 to 31, 2025, in Okayama, Japan. A total of 15 presentations1, including results from 7 clinical trials, 3 post-hoc analyses2 and 5 non-clinical studies supported by Sumitomo Pharma, will be delivered by leading Japanese diabetes experts. These findings further confirm TWYMEEG®'s efficacy in monotherapy and combination therapies, safety, dual mechanism of action and potential benefits in specific patient populations. Main topics include: TWINKLE (TWYMEEG® in diabetic patients with renal impairment: A post-marketing long-term study) study (Phase 4 study): confirmation of TWYMEEG® efficacy and safety in diabetic patients with renal impairment FAMILIAR Study: confirmation of TWYMEEG® efficacy and safety in combination with DPP-4 inhibitors PARADIME Clamp: confirmation of TWYMEEG® dual mechanism of action in diabetic patients – clinical data showing effects on insulin sensitivity (clamp part) and glucose stimulated insulin secretion (OGTT part) PARADIME TIR: confirmation of TWYMEEG® effects on glucose variability PET/MRI Study: confirmation of TWYMEEG® effect on glucose excretion in the gut Thomas Kuhn, Chief Executive Officer of Poxel, stated: "We are proud to see the scientific community's continued interest and the commitment of our partner Sumitomo Pharma to document and promote TWYMEEG®'s attributes and value. These presentations further support the product's clinical and commercial trajectory in Japan. They also highlight its value proposition for Japan and other territories and its unique profile across diverse patient subgroups." About Poxel SA Poxel is a clinical stage biopharmaceutical company developing innovative treatments for chronic serious diseases with metabolic pathophysiology, including metabolic dysfunction-associated steatohepatitis (MASH) and rare disorders. For the treatment of MASH, PXL065 (deuterium-stabilized R-pioglitazone) met its primary endpoint in a streamlined Phase 2 trial (DESTINY-1). In rare diseases, development of PXL770, a first-in-class direct adenosine monophosphate-activated protein kinase (AMPK) activator, is focused on the treatment of adrenoleukodystrophy (ALD) and autosomal dominant polycystic kidney disease (ADPKD). TWYMEEG® (Imeglimin), Poxel's first-in-class product that targets mitochondrial dysfunction, is now marketed for the treatment of type 2 diabetes in Japan by Sumitomo Pharma and Poxel expects to receive royalties and sales-based payments. Poxel has a strategic partnership with Sumitomo Pharma for Imeglimin in Japan. Listed on Euronext Paris, Poxel is headquartered in Lyon, France, and has subsidiaries in Boston, MA, and Tokyo, Japan. For more information, please visit: All statements other than statements of historical fact included in this press release about future events are subject to (i) change without notice and (ii) factors beyond the Company's control. These statements may include, without limitation, any statements preceded by, followed by or including words such as "target," "believe," "expect," "aim," "intend," "may," "anticipate," "estimate," "plan," "project," "will," "can have," "likely," "should," "would," "could" and other words and terms of similar meaning or the negative thereof. Forward-looking statements are subject to inherent risks and uncertainties beyond the Company's control that could cause the Company's actual results or performance to be materially different from the expected results or performance expressed or implied by such forward-looking statements. The Company does not endorse or is not otherwise responsible for the content of external hyperlinks referred to in this press release. Appendix Title Main Results Speaker Institution Type A post-marketing clinical trial to evaluate the safety, tolerability, and efficacy of Imeglimin in Japanese type 2 diabetes patients with renal impairment (Twinkle Study results;Phase 4) Imeglimin was shown to be safe and effective in patients with T2D associated with renal dysfunction with eGFR less than 45 mL/min/1.73 m2 Dr. Babazono Ishikawa Memorial Association Clinical Efficacy and safety of Imeglimin as an add-on treatment in type 2 diabetes patients treated with DPP-4 inhibitors: interim analysis of the FAMILIAR study Combination therapy of Imeglimin and DPP-4 inhibitors significantly reduced HbA1c at 24 weeks in type 2 diabetes patients with inadequate glycemic control with DPP-4 inhibitor therapy, confirming that Imeglimin may be a new treatment option when combined with a DPP-4 inhibitor regardless of age. Dr. Kaku Kawasaki Medical School Clinical Comparison of the effects of Imeglimin and metformin on insulin and incretin secretion Imeglimin enhanced insulin secretion as well as increased not only GLP-1 but also GIP secretion, unlike metformin Dr. Omori Kansai Electric Power Hospital Clinical Effect of Imeglimin use on Time in Range in type 2 diabetes: A multicenter randomized controlled trial (Paradime-TIR) Imeglimin alone and in combination with DPPIV inhibitors increased Time in Range by more than 10% without increasing Time Below Range, confirming the efficacy of the product in reducing glycemic variability Dr. Ueda Kobe Univ. Clinical The effects of Imeglimin and metformin on insulin secretion and sensitivity (Paradime-Clamp; OGTT part) No differences were observed between Imeglimin and Metformin on glucose lowering effects, and on insulin secretion and insulin sensitivity effects Dr. Yamada Kobe Univ. Clinical The effects of Imeglimin and metformin on insulin secretion and sensitivity (Paradime-Clamp; Clamp part) No differences were observed between Imeglimin and Metformin on insulin secretion, insulin sensitivity and their ability to switch energy sources Dr. Katsura Kobe Univ. Clinical Effects on glucose excretion to gut by using FDG/PET MRI study Imeglimin improved glucose excretion into the intestinal lumen Dr. Fukumitsu Kobe Univ. Clinical Post-hoc analysis (Atypical cluster analysis of Imeglimin + Metformin) The highest A1c reduction of the combination Imeglimin + metformin was observed in obese patients or those with a high baseline HbA1c Kitayama SMP Clinical Post-hoc analysis: Insulin combination therapy Combination therapy with Imeglimin and insulin exerted glucose lowering effects independent of obesity type Hagi, PhD SMP Clinical Post-hoc analysis: Monotherapy Imeglimin monotherapy exerted glucose lowering effects independent of obesity type Maruyama SMP Clinical Vascular protection effects of Imeglimin, a mitochondrial function-improving drug Imeglimin showed protective effect against vascular lesions like SGLT2 inhibitors and GLP-1 receptor agonists Dr. Iwazawa Juntendo Univ. Shizuoka Hospital Non-clinical Effect of Imeglimin on diabetic neuropathy in type 1 diabetic rat models Imeglimin may be effective against diabetic neuropathy as shown in this study in STZ-induced diabetic rats, Dr. Nihei Aichi Gakuin Univ. Non-clinical Combined effects of anaerobic exercise and Imeglimin on skeletal muscles The combination of Resistance Training and Imeglimin may be an effective treatment by improving mitochondrial function, glucose metabolism and glucose uptake Dr. Ishiguro Niigata Univ. Non-clinical Effect of Imeglimin on periodontitis associated with type 1 diabetes Imeglimin may be useful in preventing the worsening of periodontal disease due to type 1 diabetes. Dr. Kondo Aichi Gakuin Univ. Non-clinical Imeglimin effect on intestinal gene expression Imeglimin induced similar gene expression as metformin in the whole intestinal tissue, but single-cell analysis revealed different effects on specific cell types, including intestinal cell clusters and macrophage clusters Dr. Hozumi Kobe Univ. Non-clinical _________________________________ 1 Detailed program included in Appendix 2 Refers to a statistical analysis specified after a study has been concluded and the data collected View source version on Contacts Investor relations / Media NewCapAurélie Manavarere, Théo Martin / Arthur Rouilléinvestors@ +33 1 44 71 94 94 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


Business Wire
28-05-2025
- Health
- Business Wire
New Clinical and Scientific Data on TWYMEEG
LYON, France--(BUSINESS WIRE)--Regulatory News: POXEL SA (Euronext : POXEL - FR0012432516), a clinical stage biopharmaceutical company developing innovative treatments for chronic serious diseases with metabolic pathophysiology, including metabolic dysfunction-associated steatohepatitis (MASH) and rare metabolic disorders, today announces that new clinical and scientific data on TWYMEEG ® will be presented at the 68 th Annual Meeting of the Japan Diabetes Society (JDS 2025), taking place from May 29 to 31, 2025, in Okayama, Japan. A total of 15 presentations 1, including results from 7 clinical trials, 3 post-hoc analyses 2 and 5 non-clinical studies supported by Sumitomo Pharma, will be delivered by leading Japanese diabetes experts. These findings further confirm TWYMEEG ® 's efficacy in monotherapy and combination therapies, safety, dual mechanism of action and potential benefits in specific patient populations. Main topics include: TWINKLE (TW YMEEG ® in d i abetic patients with re n al impairment: A post-mar k eting l ong-t e rm study) study (Phase 4 study): confirmation of TWYMEEG ® efficacy and safety in diabetic patients with renal impairment FAMILIAR Study: confirmation of TWYMEEG ® efficacy and safety in combination with DPP-4 inhibitors PARADIME Clamp: confirmation of TWYMEEG ® dual mechanism of action in diabetic patients – clinical data showing effects on insulin sensitivity (clamp part) and glucose stimulated insulin secretion (OGTT part) PARADIME TIR: confirmation of TWYMEEG ® effects on glucose variability PET/MRI Study: confirmation of TWYMEEG ® effect on glucose excretion in the gut Thomas Kuhn, Chief Executive Officer of Poxel, stated: 'We are proud to see the scientific community's continued interest and the commitment of our partner Sumitomo Pharma to document and promote TWYMEEG ® 's attributes and value. These presentations further support the product's clinical and commercial trajectory in Japan. They also highlight its value proposition for Japan and other territories and its unique profile across diverse patient subgroups.' About Poxel SA Poxel is a clinical stage biopharmaceutical company developing innovative treatments for chronic serious diseases with metabolic pathophysiology, including metabolic dysfunction-associated steatohepatitis (MASH) and rare disorders. For the treatment of MASH, PXL065 (deuterium-stabilized R -pioglitazone) met its primary endpoint in a streamlined Phase 2 trial (DESTINY-1). In rare diseases, development of PXL770, a first-in-class direct adenosine monophosphate-activated protein kinase (AMPK) activator, is focused on the treatment of adrenoleukodystrophy (ALD) and autosomal dominant polycystic kidney disease (ADPKD). TWYMEEG ® (Imeglimin), Poxel's first-in-class product that targets mitochondrial dysfunction, is now marketed for the treatment of type 2 diabetes in Japan by Sumitomo Pharma and Poxel expects to receive royalties and sales-based payments. Poxel has a strategic partnership with Sumitomo Pharma for Imeglimin in Japan. Listed on Euronext Paris, Poxel is headquartered in Lyon, France, and has subsidiaries in Boston, MA, and Tokyo, Japan. For more information, please visit: All statements other than statements of historical fact included in this press release about future events are subject to (i) change without notice and (ii) factors beyond the Company's control. These statements may include, without limitation, any statements preceded by, followed by or including words such as 'target,' 'believe,' 'expect,' 'aim,' 'intend,' 'may,' 'anticipate,' 'estimate,' 'plan,' 'project,' 'will,' 'can have,' 'likely,' 'should,' 'would,' 'could' and other words and terms of similar meaning or the negative thereof. Forward-looking statements are subject to inherent risks and uncertainties beyond the Company's control that could cause the Company's actual results or performance to be materially different from the expected results or performance expressed or implied by such forward-looking statements. The Company does not endorse or is not otherwise responsible for the content of external hyperlinks referred to in this press release. Appendix A post-marketing clinical trial to evaluate the safety, tolerability, and efficacy of Imeglimin in Japanese type 2 diabetes patients with renal impairment (Twinkle Study results;Phase 4) Imeglimin was shown to be safe and effective in patients with T2D associated with renal dysfunction with eGFR less than 45 mL/min/1.73 m2 Dr. Babazono Ishikawa Memorial Association Clinical Efficacy and safety of Imeglimin as an add-on treatment in type 2 diabetes patients treated with DPP-4 inhibitors: interim analysis of the FAMILIAR study Combination therapy of Imeglimin and DPP-4 inhibitors significantly reduced HbA1c at 24 weeks in type 2 diabetes patients with inadequate glycemic control with DPP-4 inhibitor therapy, confirming that Imeglimin may be a new treatment option when combined with a DPP-4 inhibitor regardless of age. Dr. Kaku Kawasaki Medical School Clinical Comparison of the effects of Imeglimin and metformin on insulin and incretin secretion Imeglimin enhanced insulin secretion as well as increased not only GLP-1 but also GIP secretion, unlike metformin Dr. Omori Kansai Electric Power Hospital Clinical Effect of Imeglimin use on Time in Range in type 2 diabetes: A multicenter randomized controlled trial (Paradime-TIR) Imeglimin alone and in combination with DPPIV inhibitors increased Time in Range by more than 10% without increasing Time Below Range, confirming the efficacy of the product in reducing glycemic variability Dr. Ueda Kobe Univ. Clinical The effects of Imeglimin and metformin on insulin secretion and sensitivity (Paradime-Clamp; OGTT part) No differences were observed between Imeglimin and Metformin on glucose lowering effects, and on insulin secretion and insulin sensitivity effects Dr. Yamada Kobe Univ. Clinical The effects of Imeglimin and metformin on insulin secretion and sensitivity (Paradime-Clamp; Clamp part) No differences were observed between Imeglimin and Metformin on insulin secretion, insulin sensitivity and their ability to switch energy sources Dr. Katsura Kobe Univ. Clinical Effects on glucose excretion to gut by using FDG/PET MRI study Imeglimin improved glucose excretion into the intestinal lumen Dr. Fukumitsu Kobe Univ. Clinical Post-hoc analysis (Atypical cluster analysis of Imeglimin + Metformin) The highest A1c reduction of the combination Imeglimin + metformin was observed in obese patients or those with a high baseline HbA1c Kitayama SMP Clinical Post-hoc analysis: Insulin combination therapy Combination therapy with Imeglimin and insulin exerted glucose lowering effects independent of obesity type Hagi, PhD SMP Clinical Post-hoc analysis: Monotherapy Imeglimin monotherapy exerted glucose lowering effects independent of obesity type Maruyama SMP Clinical Vascular protection effects of Imeglimin, a mitochondrial function-improving drug Imeglimin showed protective effect against vascular lesions like SGLT2 inhibitors and GLP-1 receptor agonists Dr. Iwazawa Juntendo Univ. Shizuoka Hospital Non-clinical Effect of Imeglimin on diabetic neuropathy in type 1 diabetic rat models Imeglimin may be effective against diabetic neuropathy as shown in this study in STZ-induced diabetic rats, Dr. Nihei Aichi Gakuin Univ. Non-clinical Combined effects of anaerobic exercise and Imeglimin on skeletal muscles The combination of Resistance Training and Imeglimin may be an effective treatment by improving mitochondrial function, glucose metabolism and glucose uptake Dr. Ishiguro Niigata Univ. Non-clinical Effect of Imeglimin on periodontitis associated with type 1 diabetes Imeglimin may be useful in preventing the worsening of periodontal disease due to type 1 diabetes. Dr. Kondo Aichi Gakuin Univ. Non-clinical Imeglimin effect on intestinal gene expression Imeglimin induced similar gene expression as metformin in the whole intestinal tissue, but single-cell analysis revealed different effects on specific cell types, including intestinal cell clusters and macrophage clusters Dr. Hozumi Kobe Univ. Non-clinical Expand _________________________________ 1 Detailed program included in Appendix 2 Refers to a statistical analysis specified after a study has been concluded and the data collected Expand