The data of Phase 1 in japanese subjects demonstrate the safety and good tolerance of the Imeglimine and a pharmacokinetic profile similar to that observed in subjects of type caucasians
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Data mechanistic of the Imeglimine show a protective effect of pancreatic beta-cells and a unique mechanism of action on the secretion of insulin in response to glucose
Lyon, France, on may 22, 2017 POXEL SA (Euronext POXEL – FR0012432516, PEA-PME), a biopharmaceutical company specializing in the development of innovative treatments against metabolic diseases, including type 2 diabetes, today announced the presentation of data from the Phase 1 study on the Imeglimine carried out in healthy volunteers in japanese, as well as preclinical data supporting the unique mechanism of action of the Imeglimine on the secretion of insulin in response to glucose. These results have been presented in the framework of the 9th scientific meeting of AASD (Asian Association for the Study of Diabetes) in Nagoya, Japan.
Phases 1 and 2 of the clinical development of the Imeglimine are now completed and have been used to collect data from approximately 1,200 patients and healthy subjects in the United States, Europe and Japan.
The Phase 3 program may now be initiated.
“We are proud to be able to present at this prestigious scientific meeting on diabetes, the results of the Phase 1 study on the Imeglimine conducted in healthy volunteers in japanese, as well as important data mechanistic that could explain, at least partially, the robustness of the efficacy results that we observed at the end of Phase 2b in patients with diabetes japanese,” said Thomas Kuhn, ceo of Poxel. “Diabetes is a health problem of growing concern in Asia. Japan is a key market and occupies a place of priority in our business strategy. We believe that the Imeglimine could become a new therapeutic option innovative to control type 2 diabetes in Japan. Given that his profile is differentiated, the Imeglimine is a prime candidate to become a first-line treatment in monotherapy, and in combination with other treatments hypoglycemic agents. Poxel plans to initiate the Phase 3 program on the Imeglimine in Japan in the fourth quarter of 2017. ”
In the first presentation, entitled ” Safety, tolerance and pharmacokinetics of the Imeglimine in healthy volunteers in japanese “, the scientific director of Poxel has presented a summary of all the data of the study Phase 1, randomized, double blind and with placebo control, conducted in 48 subjects japanese. These data have demonstrated a good safety profile up to 6000 mg, as well as the absence of signal alert on the safety of the product after the phase of administration of repeated doses for 7 days. In addition, the pharmacokinetic profiles observed in the japanese subjects were similar to those observed previously in subjects of caucasian type.
The second oral presentation entitled “The Imeglimine increases the secretion of insulin in response to glucose by a unique mechanism of action-dependent synthesis of NAD” brings up results that improve the understanding of the unique mechanism of action of the Imeglimine in order to improve the secretion of insulin in response to glucose. This effect has been demonstrated in different preclinical models of diabetes, as well as in patients with type 2 diabetes. This increase of insulin secretion in response to glucose is dependent on the effect of the Imeglimine on the biosynthesis of NAD (nicotinamide adenine dinucleotide), a coenzyme which plays a crucial role in mitochondrial function.
In addition to improving the functioning of the beta cells of the pancreas, the Imeglimine also helps to preserve the mass of these cells, which could delay the progression of the disease. In addition, a synergistic effect was observed between the Imeglimine, and GLP-1 on insulin secretion in response to glucose, highlighting a mode of action distinct from that of GLP-1. In addition to being a prime candidate for monotherapy, these data justify the use of the Imeglimine in combination with agonists of the GLP-1 and inhibitors of DPP-IV.
“We have made significant progress in the understanding of the dual mechanistic insight of the Imeglimine, which leads to the improvement of both insulin sensitivity and insulin secretion, the two key defects of type 2 diabetes,” commented Sébastien Bolze, Doctor of Pharmacy, Ph.D, Chief Scientific officer and Executive Vice President of the Non-Clinical Development of Poxel. “The effect of the Imeglimine on the secretion of insulin may be particularly suitable for japanese patients, in whom type 2 diabetes might be characterized by a deficit in early insulin secretion. This important effect may have also contributed to the high efficacy observed in the japanese patients in our Phase 2b. ”
The two presentations of the 9th scientific meeting of the AASD are available on the website of the Company, under ” Publication-Scientific “, or by clicking on this link.
About the Imeglimine
The first representative of a new chemical class of oral agents, the Glimines. The Imeglimine acts on three main target organs involved in glucose homeostasis : the liver, muscles and pancreas. The Imeglimine has a unique mechanism of action which targets the mitochondrial bioenergetics. The result is a potential effect in reducing blood sugar levels, as well as the potential to prevent endothelial dysfunction, which may have protective effects against the micro-and macrovascular complications induced by diabetes, and the benefits of the protection and beta-cell function, which may slow down the progress of the disease. This mode of action distinct from that of existing treatments for type 2 diabetes because of the Imeglimine a candidate of choice as monotherapy and as an adjunct to other treatments such as metformin, or sitagliptin.
About Poxel – www.poxel.com
Poxel is based on its level of development expertise in metabolism to develop and enhance a portfolio of drug candidates, currently focused on type 2 diabetes. We have completed the development of phase 2 in the United States and Europe our product is the most advanced, the Imeglimine, the first of a new class of therapeutic targeting of the mitochondrial dysfunction, and which entered into clinical development to phase 2b in japanese patients. We are continuing the development of our 2nd program, the PXL770, an activator direct AMPK. We intend to generate growth through strategic partnerships and the development of our portfolio.
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