StemCell Therapy

Poxel and its new diabetes tablet are heading to regulators. Well, in Japan at least.

The French pharma and its Japanese partner Sumitomo Dainippon announced the third straight Phase III success for its new kind of diabetes tablet. In the year-long, open-label TIMES 2 trial, Imeglimin decreased blood sugar levels (HbA1c) as a monotherapy or in combination with one of any of 8 common diabetes drugs. That included a .92% decline when given with DDP-4 inhibitors, one of the most common diabetes meds in Japan.

The results keep Poxelon track for the same 2020 Japanese regulatory submission and 2021 approval they laid out after positive double-blind TIMES 1 results were announced in April. Top-line TIMES 3 results, also positive, were unveiled in November.

The results sent Poxels stock on the European exchange up 9.92% to 9.75 per share.

The TIMES 2 results represent a significant milestone for Imeglimin, with the completion of our robust Phase 3 program in Japan, Poxel CEO Thomas Kuhn said in a statement referring to all three trials. Taken together, these results feature Imeglimins potential to treat type 2 diabetes at multiple stages of the disease.

Poxels path to the rest of the world remains less clear. Nearly two years ago, the French group sold US and European rights to Vivek Ramaswamys Roivant in a deal worth $50 million upfront and up to $600 million in milestones. The deal had been long-sought; although Poxel had a positive Phase IIb in 2014 and dosing levels to go to Phase III, they needed a deeper-pocketed partner willing to take on the heavy financial burden of a global diabetes trial.

Updates, though, have been sparse since they signed that deal in February 2018. The Poxel website still lays out the 2018 plans under the Imeglimin US/EU tab, and the Roivant website refers back to the Poxel one. Clinicaltrials.gov lists only one active trial for the drug a Phase I in Munich for hepatic impaired subjects.

The compound, though, will enter the Japanese regulatory process with a bevy of evidence behind it. Part of a new class of oral chemical agents called glimins, the drug is designed to target all three key organs affected in Type II diabetes: Increasing insulin in the pancreas in a glucose-dependent manner, decreasing excess glucose production in the liver and enhancing insulin sensitivity in muscles.

Collectively, the three trials enrolled 1,100 patients. TIMES 2 was open-label but TIMES 1 and 3 were double-blind. All met primary endpoints.

Poxel should find a ready market, too. An aging population and rising obesity have swelled the number of suspected diabetics in Japan past 10 million as of 2016, according to past estimates from Nikkei.

Read the original post:
Poxel passes 3rd straight Phase III diabetes trial in Japan, but what's going on with US/EU partner Roivant? - Endpoints News

This entry was posted on December 30, 2019 at 4:00 am and is filed under Diabetes. You can follow any responses to this entry through the RSS 2.0 feed. Both comments and pings are currently closed. |