StemCell Therapy

A phase 2b trial of Poxels Type 2 diabetes candidate imeglimin has met its primary endpoint. The data sent shares in Poxel soaring 40% and set the company up to push into a phase 3 trial before the end of the year.

Investigators in Japan enrolled 299 patients and randomized them to receive one of three doses of imeglimin or placebo. Participants received the treatment twice a day for 24 weeks. The primary endpoint looked at glycated hemoglobin A1c, a type of hemoglobin that shows the three-month average plasma glucose concentration. A secondary efficacy endpoint looked at levels of fasting plasma glucose.

All three doses of imeglimin outperformed placebo in terms of reducing levels of the hemoglobin. The response was dose dependent. Subjects who received the lowest, 500 mg dose experienced a reduction of 0.52%. Participants who took the highest, 1500 mg dose experienced a reduction of 1.00%. The declines are larger than those seen in earlier trials in the U.S. and Europe.

Dose dependency was also evident in the analysis of the secondary endpoint. Only the two higher doses1000 mg and 1500 mgmet that endpoint. Analysis of additional secondary endpoints is ongoing. Poxel said the safety profile was consistent with that seen in earlier trials. Those studies found the safety profile of imeglimin was comparable to placebo.

Buoyed by the data, Poxel plans to talk to regulators in Japan in the third quarter and kick off a phase 3 study in the fourth quarter. That would set Poxel up to generate pivotal data in a market that is central to its plans.

In Japan, we believe imeglimin may be a prime candidate for first-line treatment as monotherapy and as an add-on to other glucose lowering therapies for the treatment of patients with Type 2 diabetes, Poxel CEO Thomas Kuhn said in a statement. Japan represents the second largest single market for Type 2 diabetes and is expected to grow to approximately $6 billion (5.5 billion) in annual sales in 2020.

Kuhn has previously expressed a willingness for Poxel to run clinical trials of imeglimin in Japan without the support of a partner but bring someone on board to handle commercialization. Poxel raised 26.5 million last year to fund a phase 3 trial in Japan. That round came two months after Poxel floated the idea of a Nasdaq IPO, only to back away in the face of an unreceptive market.

The development strategy in Europe and the U.S. is different. Poxel has long expressed an interest in partnering the asset in those markets before taking it into phase 3.

Merck Serono spinout Poxel thinks imeglimin can claim a slice of the diabetes market by affecting the bioenergetics of mitochondria and, in doing so, preserve the function of beta cells.

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Poxel shares jump 40% after diabetes trial hits primary goal - FierceBiotech

This entry was posted on May 4, 2017 at 2:51 pm 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. |