BOSTON—Poxel SA of Lyon, France, presented data at the American Diabetes Association’s 75th Scientific Sessions showing that the biopharmaceutical company’s lead candidate, the first-in-class oral anti-diabetic agent imeglimin, has met glycemic endpoints in a dose-ranging Phase 2b study. The data corroborate beneficial safety and tolerability data seen for imeglimin in all previously conducted trials.
Subjects in the clinical trial tolerated all doses of imeglimin well with a safety profile that was comparable to placebo. There were no treatment-emergent serious adverse events related to imeglimin or placebo reported in the study at this dosage.
According to Dr. Harold Lebovitz, a professor of medicine in the Division of Endocrinology and Metabolism/Diabetes at State University of New York and a member of Poxel’s scientific advisory board, “Imeglimin holds great promise through both its success in meeting the trial’s endpoints and its excellent safety/tolerability profile. The study underscores imeglimin’s potential as a truly innovative treatment for type 2 diabetes, as both an effective monotherapy and combination therapy with the current standard of care.”
Imeglimin is the first in a new class of oral antidiabetic drugs—the glimins—that, in contrast to other agents, simultaneously target all three key organs involved in diabetes pathophysiology: the pancreas, the liver and the muscles.
As explained by Dr. Pascale Malgouyres, chief commercial officer and co-founder of Poxel, “The key differentiator of imeglimin is that it targets mitochondria bioenergetics, thus improving mitochondrial function, resulting in increasing glucose-dependent insulin secretion from the pancreas and improving insulin action in the liver and muscles. It decreases the excess production of glucose by the liver and increases the effectiveness and uptake of insulin in the muscle.”
Additionally, imeglimin is able to fully protect beta cells and endothelial cells from death induced by oxidative stress, such as food, according to Malgouyres. “In summary, imeglimin is the only product addressing both key defects of [type 2 diabetes], insulin secretion deficiency and insulin sensitivity impairment,” she says.
Poxel was founded in 2009 as a spin-off of Merck Serono, a big player in the type 2 diabetes arena at that time, and the team that later became the co-founders of Poxel had been leading Merck’s diabetes franchise.
“Following Merck’s acquisition of Serono in 2007, the new corporate strategy led to a strategic decision to divest from the primary care R&D, and in 2009, our team managed to work with Merck Serono’s board to acquire their attractive pipeline of new and early-stage products, one of which is imeglimin,” Malgouyres relates.
Poxel has completed imeglimin Phase 2 development in the European Union and United States and is currently in the process of selecting a partner for Phase 3 development in these territories. Simultaneously, the company has initiated imeglimin’s Asian development, recently completing a Phase 1 study in Japanese subjects.
Existing therapies on the market to treat type 2 diabetes are dominated by a small number of product classes. All existing products have major shortcomings in terms of long-term efficacy and safety, as well as ease of administration and patient compliance, according to Malgouyres. She concludes: “Imeglimin’s unique characteristics, such as its oral availability and its distinct potential to target both insulin secretion and insulin sensitivity while, at the same time, being very safe and well tolerated and thus suitable for both mono- and combination therapy, entail a significant commercial potential of more than 4 billion pounds at peak.”
