Emboldened by new clinical data, French biotech Poxel and partner Metavant are planning a phase 3 programme in the US and Europe for their diabetic kidney disease therapy imeglimin.
Top-line results from a pharmacokinetic and pharmacodynamic trial for the orally-active drug – claimed to be the first in a new class of antidiabetics – are key to unlocking a pivotal trial programme for imeglimin outside Japan, where two phase 3 studies have already generated positive results in diabetes.
The study tested the ‘glimin’ drug in subjects with type 2 diabetes and moderate to severe (stage 3b/4) chronic kidney disease (CKD), and backed up the safety, tolerability and clinical profile of the drug seen in earlier trials.
The new data adds to a building body of evidence behind imeglimin after around a decade of development at Poxel, a spin-out of Merck KGaA formed specifically to advance the drug.
The French company signed an agreement with Sumitomo Dainippon Pharma in 2017 for development rights to the drug in Asian markets including Japan, which has a slightly lower bar for testing diabetes drugs than the US and Europe, and said in April and June that two of three planned trials (TIMES-1 and TIMES-2) was positive.
The third TIMES-3 trial is due to read out before the end of this year, and if positive will set up a Japanese filing in 2020.
Roivant Sciences subsidiary Metavant licensed US and European rights to the drug last year for $35m upfront, a $15m equity investment and up to $500m in milestone payments. Poxel agreed to stump up a $25m contribution for the development programme.
Imeglimin is thought to work against mitochondrial dysfunction in cells, which Poxel maintains is a cause of diabetes. In studies conducted to date, imeglimin has shown it can lower glucose by increasing insulin secretion, raising insulin sensitivity in tissues, and suppressing glucose synthesis in the liver.
Poxel and Metavant note that patients with type 2 diabetes and CKD have few treatment options to improve glucose control, and those drugs that are available may be associated with an increased risk of side effects like hypoglycaemia or lactic acidosis.
Commenting on the new data, Poxel’s chief executive Christophe Arbet-Engels said the results “demonstrate imeglimin’s potential in a patient population where the disease is advanced and treatment options for blood glucose control are significantly reduced.”
“The results are consistent with our phase 2 data in the US and Europe and phase 2b and phase 3 data in Japan, in which imeglimin was observed to demonstrate similar safety and efficacy in patients with impaired renal function compared to patients with normal renal function.”