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: www.poxelpharma.com
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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 |
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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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