NeuroMax has received permission from the Ministry of Health of the Russian Federation to conduct Phase Ib clinical trial to study the safety and pharmacokinetics of developed drug candidate NM-IA-001 (BNV-222, choline diepalrestat) in patients with diabetic polyneuropathy. This study is scheduled to start in May and will be conducted on the basis of specialized medical centers in Perm, Yaroslavl and Rostov-on-Don. The company has previously announced the successful completion of Phase Ia clinical trial conducted on the basis of the clinical center E.A. Wagner Perm State Medical Academy.
The new clinical study will be a “Double-blind, placebo-controlled, randomized study of the safety and pharmacokinetics BNV-222 (choline diepalrestat) at doses of 150 mg and 300 mg in patients with diabetic polyneuropathy”.
"The design of the new study will provide extensive information about the safety of our drug candidate and its pharmacokinetic properties, as well as give us the opportunity to select the appropriate dosage in order develop the best course of treatment in the future,” said Nikolay Golub, CEO of NeuroMax.
NeuroMax was created with investments from Maxwell Biotech Venture Fund founded with the participation of RVC. NeuroMax develops and commercializes innovative drug products for the treatment of diseases of the central and peripheral nervous system. Drug candidate NM-IA-001 (BNV-222), licensed from and developed in close partnership with the U.S. biotechnology company BioNevia Pharmaceuticals Inc., is a small molecule inhibitor of the aldose reductase enzyme designed for the treatment of complications caused by diabetes. The main application of NM-IA-001 (BNV-222) is diabetic neuropathy, although additional focus will be centered on diabetic nephropathy and retinopathy.