Biopharmaceutical firm Poxel is planning to submit a Japanese new drug application (JNDA) next year for its experimental drug Imeglimin, which is being developed as an oral anti-diabetic.
The company announced positive topline results for Imeglimin in the Phase III TIMES 3 trial for the treatment of type 2 diabetes in Japan.
The 36-week, open-label extension period of the trial assessed Imeglimin in combination with insulin and was observed to show consistent and sustained efficacy.
Imeglimin in combination with insulin was also found to demonstrate a favourable safety and tolerability profile throughout the 52 weeks of treatment in TIMES 3.
The earlier 16-week, double-blind placebo-controlled randomised part of the TIMES 3 trial was observed to demonstrate efficacy and achieved statistical significance (p<0.0001) for its primary endpoint.
The open-label extension period was not placebo-controlled. A total of 208 Japanese patients who completed the initial 16 weeks of the study were administered 1,000mg Imeglimin orally twice-daily, as well as insulin therapy for the next 36 weeks.
Poxel said the safety and tolerability profile of Imeglimin was found to be favourable for the entire portion of the 52-week trial with no severe hypoglycemia events. The company noted that most of the hypoglycemia events reported were mild.
TIMES (Trials of Imeglimin for Efficacy and Safety), the Phase III programme for Imeglimin to treat type 2 diabetes in Japan, consists of three pivotal trials involving more than 1,100 patients.
Poxel CEO Thomas Kuhn said: “These data demonstrate efficacy with a favourable safety and tolerability profile in a different patient population than the TIMES 1 monotherapy trial and we are looking forward to the TIMES 2 results evaluating Imeglimin in combination with marketed therapies available in Japan.
“We are continuing to work very closely with our partner, Sumitomo Dainippon Pharma, in preparing for the Japanese new drug application and the TIMES 3 results bring us one step closer to achieving that goal.”
Imeglimin acts on all three key organs that play a key role in the treatment of type 2 diabetes. The clinical candidate’s unique mechanism of action targets mitochondrial bioenergetics.