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
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1
Detailed program included in Appendix
2
Refers to a statistical analysis specified after a study has been concluded and the data collected
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