Poxel posts phase 3 diabetes data ahead of approval decision

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Roivant paid $35 million upfront to secure ex-Asia rights to Type 2 diabetes drug imeglimin in 2018. (Pixabay)

Poxel has shared the phase 3 data it hopes will secure approval for Type 2 diabetes drug imeglimin in Japan. The readouts link the oral oxidative phosphorylation blocker imeglimin to near- and long-term improvements when given as a monotherapy and in combination with other drugs.

One year ago, Poxel used the European Association for the Study of Diabetes (EASD) Annual Meeting to share detailed data from the TIMES 1 trial, a key component of its effort to win approval for the drug in Japan in partnership with Sumitomo Dainippon Pharma. At EASD 2020, with imeglimin now under review at the Japanese regulator, Poxel showcased data from the other two key studies in its Japanese strategy, TIMES 2 and TIMES 3.

In the open-label TIMES 2, investigators gave 1,000 mg or imeglimin orally twice a day as an add-on to a range of approved diabetes drugs. The combination of imeglimin and DPP-4 inhibitors, such as Merck’s Januvia and AstraZeneca’s Onglyza, drove a 0.92% reduction in mean HbA1c.

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Other cocktails were less effective, with Poxel seeing reductions of 0.67% and 0.57%, respectively, when it gave imeglimin in combination with metformin and SGLT-2 inhibitors. But the nature of how diabetes is treated in Japan means the DPP-4 combination result may be the key data point.  

Japan has approved more DPP-4 inhibitors than many other markets, and the class is a mainstay of Type 2 diabetes care in the country. Poxel cited data showing that DPP-4 inhibitors are prescribed to 80% of Type 2 diabetics in Japan. 

Poxel presented the data alongside results from the open-label extension to TIMES 3. In the original 16-week study period, Poxel linked imeglimin to a 0.60% mean placebo-corrected reduction in HbA1c from baseline. The open-label extension shows the improvement persisted out to 52 weeks. 

Subjects who received imeglimin during the 16-week placebo-controlled period experienced a mean reduction in HbA1c of 0.64% by the end of the extended follow-up. The decline in participants who spent the first 16 weeks on placebo before switching to imeglimin for the extension was 0.54%.

Sumitomo, which secured the Japanese rights to imeglimin in 2017, packaged the data up for a filing for approval in its home country earlier this year. Poxel expects the Japanese regulator to make a decision in time for imeglimin to come to market next year.

Work to get imeglimin to market in other countries was held up by a delay between Poxel identifying the phase 3 dose and getting the support to move into a pivotal trial. Poxel posted phase 2b late in 2014 but only secured a partnership in 2018, when Roivant paid $35 million upfront to secure rights to the drug and put it at the heart of its Metavant business. 

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