NeuroMax has successfully completed Phase Ia clinical trials on the safety and pharmacokinetics of drug candidate NM-IA-001 (BNV-222) for patients with diabetic neuropathy. Previously approved by the Ministry of Health of the Russian Federation the study was conducted at the E.A. Wagner Perm State Medical Academy.
According to a preliminary report based on the results of the study, NM-IA-001 (BNV-222) is well-tolerated, safe, and can be recommended for further clinical trials for drug registration in the Russian Federation.
"Analysis of the preliminary data obtained in our study confirms the good tolerability and safety profile of NM-IA-001 in all 18 patients who participated in this clinical trial and we hope that with these results we will be able to move in the near future to the next phase of clinical trials which will involve a larger number of patients and will expand the range of applicable drug doses,” 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.
Previously, NeuroMax successfully completed a series of preclinical studies on the safety of NM-IA-001 (BNV-222), and the positive results from the study enabled the company to proceed with clinical trials. Should all phases of the clinical trials produce positive results, NM-IA-001 (BNV-222) may become the first medicine in Russia for mechanism-based therapy for serious complications due to diabetes.