Poxel, Sumitomo Dainippon's experimental type 2 diabetes drug imeglimin meets main goal of Phase III study

Poxel and Sumitomo Dainippon Pharma on Tuesday announced that the investigational type 2 diabetes treatment imeglimin achieved the primary endpoint of a late-stage study, as well as hitting its main secondary goals. Poxel chief executive Thomas Kuhn said the results are "the first major step towards" filing a marking application in Japan in 2020, noting that the country "is considered the most important geographic location with regards to treating the diabetes pandemic in the future."

In the TIMES 1 study, 213 Japanese patients with type 2 diabetes were randomised to twice-daily treatment with imeglimin or placebo. In addition to the primary endpoint of change in HbA1c levels after 24 weeks, secondary goals included changes in fasting plasma glucose levels at the same time point.

Top-line results showed that imeglimin significantly reduced glycated haemoglobin A1c levels after 24 weeks versus placebo. Specifically, the oral therapy was associated with an HbA1c placebo-corrected mean change from baseline of -0.87 percent compared with placebo after 24 weeks. In addition, Poxel and Sumitomo Dainippon said the treatment was linked to placebo-corrected mean change in fasting plasma blood glucose levels versus baseline at week 24 of -19 mg/dL, meeting one of the trial's main secondary goals.

The drugmakers noted that analyses of additional secondary endpoints are ongoing, while the safety and tolerability profile of imeglimin was in line with that observed in prior studies in the US and Europe. The companies added that additional data from the trial will be presented at a future research conference.

The late-stage programme for imeglimin in Japan includes two further pivotal studies, with initial results from the 16-week TIMES 3 trial expected in mid-year. Meanwhile, data from the TIMES 2 study are anticipated around the end of 2019.

Poxel and Sumitomo Dainippon are jointly developing imeglimin, which targets mitochondrial bioenergetics, in East and Southeast Asia under the terms of a 2017 partnership. Poxel entered into a separate agreement last year with Roivant Sciences covering development of the therapy in all other markets, suggesting at the time that late-stage studies in the US and Europe could begin in 2019.

Register as Visitor to CPhI China 2019!

-----------------------------------------------------------------------
Editor's Note:

To apply for becoming a contributor of En-CPhI.cn,

welcome to send your CV and sample works to us,

Email: Julia.Zhang@ubmsinoexpo.com.