NP-135 (Bemethyl)

About NP-135 (Bemethyl)

The Company’s lead drug for non-alcoholic steatohepatitis (NASH) is Bemethyl (NP-135).  It’s representative of a class of drugs called “actoprotectors” developed during the Soviet Union era to improve performance of their military, cosmonauts and national athletes under extreme physical conditions.

NP-135 (Bemethyl: 2(Ethylthio) benzimidazole) is a drug developed in the USSR in the 1970s, and after initial tests on Soviet cosmonauts and soldiers in extreme conditions (fatigue, high altitude) the drug was used to improve athletic performance, including preparing the USSR national team for the Olympic Games. NP-135 (Bemethyl) remains registered as a drug in only three countries: Ukraine, Republic of Moldova, and Georgia (commercial names: Bemitil, Metaprot, and Bemaktor). Owing to its activity, the World AntiDoping Agency (WADA) included NP-135 (Bemethyl) in its 2018 monitoring program.

Data

Data from this study demonstrated statistically significant improvements in several key measures relevant to the development and progression of NASH including:

  • Cenicriviroc (40 mg/kg, QD) both a positive control and comparator arm in the study showed a 1.5 point drop in the NAFLD/NAS score vs controls (p<0.01) and 54.1% (p<0.0001) reduction in fibrosis area compared to controls as measured by Sirius Red staining.
  • NP-135 (200 mg/kg, QD) showed a 1.1 point drop in the NAFLD/NAS score vs controls (p>0.05) and a 84.4% reduction (p<0.0001) in fibrosis area.
  • NP-135 also showed significant anti-fibrotic activity in a unilateral urinary obstruction (UUO) model of chronic kidney disease (CKD), reducing fibrosis by 52.1% (p<0.000001).