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: www.poxelpharma.com
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
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Business Wire
26 minutes ago
- Business Wire
Somnics Health Launches iNAP Essentials: Making Innovative OSA Therapy Accessible for $58/Month
REDWOOD CITY, Calif.--(BUSINESS WIRE)--Somnics Health, a pioneer in next-generation sleep apnea solutions, announces the launch of iNAP Essentials, a breakthrough program giving patients access to iNAP Sleep Therapy for just $58/month over 24 months. This new initiative removes one of the biggest barriers to treatment—cost—and expands access to comfortable, mask-free therapy for patients with Obstructive Sleep Apnea (OSA). Sleep apnea is a serious condition, and we believe everyone deserves a shot at better health. We're making it now effective and affordable to many patients in the US. No need for insurance! Share More than 50 million Americans suffer from OSA, yet 80% remain untreated, and many who start CPAP therapy abandon it due to discomfort. The iNAP system offers a new path forward. 'The OSA treatment landscape is no longer CPAP-only. iNAP is effective, comfortable, and discreet—and now, more affordable than ever,' said Olivier Lauzeral, General Manager of Somnics Health. 'With iNAP Essentials, we're removing the affordability hurdle.' A Smarter, Simpler Solution iNAP is an FDA-cleared, clinically validated therapy that uses gentle negative pressure to keep the airway open during sleep—without forcing air through a mask. It works by creating a light vacuum in the oral cavity, shifting soft tissues forward and preventing obstruction. Key benefits include: No mask, no noise, no forced air Compact and travel-friendly Rechargeable battery lasting up to 5 nights Patients appreciate the freedom and discretion the iNAP system offers, particularly for travel and daily life. 'Adherence is one of iNAP's biggest strengths,' added Lauzeral. 'When therapy fits into your life instead of disrupting it, patients stay with it—and that's how we win against OSA.' What's Included in iNAP Essentials For $58/month for 24 months, iNAP Essentials includes: A full iNAP Starter Kit 3 months of supplies (mouthpiece, tubing) Free nationwide shipping Personalized onboarding with a trained iNAP Sleep Coach Access to the iNAP Sleep App for tracking progress and sharing data with providers After the initial supply period, patients can purchase refills as needed from Somnics' online store—offering flexibility without hidden fees or long-term commitments. 'We built this program with transparency and simplicity at its core,' said Lauzeral. 'It's everything you need to start treatment—nothing you don't.' Addressing a Changing Market While CPAP has long dominated the OSA space, patient dissatisfaction is driving demand for alternatives like oral appliances, positional therapy, and implantable devices. Many of these, however, are costly, invasive, or hard to access. iNAP stands out as non-invasive, portable, and now financially accessible. Clinical studies show iNAP can significantly reduce AHI, with outcomes on par with CPAP—but with higher comfort and adherence. More Ways to Access iNAP For patients who prefer to own their device upfront, Somnics has partnered with Affirm® to offer interest-free installment plans. 'Some patients want to purchase the device outright. With Affirm, they can do that without financial strain,' said Lauzeral. Provider-Guided, Patient-Focused iNAP is available by prescription only, ensuring medical oversight from a sleep specialist. Adoption is growing across VA hospitals, sleep centers, and DME providers. 'Physicians are seeing the value of iNAP in improving adherence and patient satisfaction,' Lauzeral emphasized. 'When patients feel empowered, they stay engaged—and that's the future of sleep medicine.' Advancing Health Equity Untreated sleep apnea increases the risk of heart disease, stroke, diabetes, and cognitive decline. Somnics Health sees iNAP Essentials not just as a product offering—but as a public health solution. 'This isn't just about access—it's about fairness,' said Lauzeral. 'Sleep apnea is a serious condition, and we believe everyone deserves a shot at better health.' About Somnics Health Somnics Health is a medical device company focused on advancing patient-centric solutions for sleep-disordered breathing. Its flagship product, iNAP Sleep Therapy, helps patients treat OSA without the discomfort of traditional therapies. With offices in California and Taiwan, Somnics continues to lead in innovation, education, and patient adherence.
Yahoo
2 hours ago
- Yahoo
New Study Demonstrates AI-Powered Care Coordination Reduces Transfer Time and Improves Outcomes in Intracerebral Hemorrhage Patients
Real-world data highlights how accelerates access to ICH treatment SAN FRANCISCO, June 09, 2025--(BUSINESS WIRE)-- the leader in AI-powered disease detection and intelligent care coordination, today announced new clinical data showcasing the impact of Viz ICH and Viz ICH Plus in optimizing care for patients with intracerebral hemorrhage (ICH). The study, "Optimizing Intracerebral Hemorrhage Management and Interhospital Transfer With Viz ICH Plus AI Technology," highlights how AI-powered detection and quantification significantly reduced interhospital transfer (IHT) time, expediting treatment and improving patient outcomes. The case study features a 47-year-old patient with a right parieto-occipital hematoma who was rapidly identified by and transferred through the Neuroemergencies Management and Transfer (NEMAT) program. The use of Viz ICH and Viz ICH Plus cut the interhospital transfer time nearly in half - from an average of 200 minutes to just 101 minutes in this case - allowing the patient to undergo successful surgical evacuation and experience significant neurological recovery over the following year. "Viz ICH has transformed how we identify and triage patients with ICH," said Christopher Kellner, MD, Director of the Intracerebral Hemorrhage Program at Mount Sinai. "By accelerating diagnosis and enabling real-time alerts across teams and hospitals, this technology streamlines the entire transfer process, ensuring patients get the care they need without unnecessary delays." Intracerebral hemorrhage accounts for up to 15% of all strokes and has high morbidity and mortality rates, requiring rapid diagnosis and intervention. Accurate volume measurements of brain bleeds are crucial for assessing the severity of cases, monitoring progression, and guiding treatment decisions. However, these measurements have traditionally been manual and time consuming. Radiologists, neurologists and neurosurgeons can incorporate Viz ICH and Viz ICH Plus seamlessly into their workflows to automate this process and support faster, more efficient care decisions. In addition to reducing transfer time, AI-powered detection and quantification has demonstrated improved efficiency in clinical workflows, with faster hematoma volume estimation and more accurate assessments compared to manual methods. The study also highlights the scalability of the solution across large, complex hospital systems where specialized ICH care may only be available at select sites. "At we are committed to using AI to close the gaps in stroke care and bring faster, more accurate treatment to every patient—no matter where they first present," said Molly Madziva Taitt, Ph.D., VP of Global Clinical Affairs at "This study is a powerful example of how AI can reduce delays, support earlier interventions, and ultimately improve outcomes for patients with intracerebral hemorrhage." To learn more about Viz ICH Plus, visit About Inc. is the pioneer in the use of AI algorithms and machine learning to increase the speed of diagnosis and care across 1,700+ hospitals and health systems in the U.S. and Europe. The AI-powered One® is an intelligent care coordination solution that identifies more patients with a suspected disease, informs critical decisions at the point of care, and optimizes care pathways and helps improve outcomes. Backed by real-world clinical evidence, One delivers significant value to patients, providers, and pharmaceutical and medical device companies. For more information visit View source version on Contacts Media Contacts Carolyn Daniel 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
2 hours ago
- Yahoo
Sesen Launches with a Singular Mission: Advancing Life Sciences Globally Through Specialized Language Solutions
BOSTON, June 09, 2025--(BUSINESS WIRE)--Today marks the official launch of Sesen, a next-generation language services company purpose-built to meet the complex demands of the life sciences industry. Specializing exclusively in translation, localization, and AI-enhanced linguistic solutions for pharmaceutical, biotechnology, medical device, CRO, and regulatory organizations, Sesen combines industry expertise with cutting-edge technology to deliver fast, accurate, and fully compliant multilingual communications across 150+ languages. Built by industry veterans, Sesen is redefining how life sciences companies manage language workflows, from clinical trial documentation and regulatory labeling to patient communications and digital health platforms. At the core of its offering is SesenGPT, a proprietary AI engine trained on life sciences terminology and optimized for medical and regulatory content. Key Capabilities Include: Regulatory-compliant translations aligned with EMA, FDA, and PMDA guidelines ISO 17100, ISO 9001:2015, and ISO 13485:2016 certified quality management AI-enabled hybrid workflows for clinical trial translations, pharmacovigilance, and labeling Native linguists and MD/PhD medical reviewers for domain-specific accuracy Scalable language solutions integrated with sponsor CMS and eTMF systems "Life sciences innovation is increasingly global, but language remains a critical barrier," said Dr. Vladimir Misik, VP of Global Clinical Trial Strategy. "We launched Sesen to solve this challenge with unmatched specialization, seamless technology integration, and the linguistic precision this industry demands." Diego Di Leva, Sesen's VP of Global Operations, and a certified ISO 9001 and ISO 13485 auditor, added: "At Sesen, language quality is not an afterthought, it's built into the DNA of every project. Our quality assurance framework is grounded in international standards and supported by linguists with deep domain expertise, ensuring every deliverable meets the highest regulatory and scientific expectations." With a growing network of linguists, in-country reviewers, and regulatory consultants, Sesen supports top pharmaceutical and biotechnology companies with on-time, compliant delivery of multilingual assets for product launches, clinical trials, and regulatory submissions. About Sesen Sesen is a specialized language solutions provider exclusively serving the life sciences industry. Focused on clinical, regulatory, and commercial translation, Sesen supports pharmaceutical, biotech, medical device, and CRO clients in 150+ languages. The company combines native linguists, medical professionals, and ISO-certified workflows with proprietary AI technology to deliver faster, more accurate, and compliant content. From clinical trial support to product localization, Sesen enables life sciences organizations to operate with linguistic confidence and regulatory precision. View source version on Contacts Media Contact: Nikki Andrewspress@ Sign in to access your portfolio
