Excellena has commenced recruitment of subjects into a Phase II randomized, double-blind, placebo-controlled clinical trial evaluating the efficacy and safety of the investigational drug Maloben in subjects with non-alcoholic fatty liver disease (NAFLD).
The multicenter study will be conducted at 10 investigational sites across various regions of Russia and plans to enroll 225 subjects. Completion of subject recruitment is expected by the end of 2026.
Maloben, developed by the St. Petersburg State Chemical-Pharmaceutical University, possesses anti-steatotic properties and targets key pathogenic pathways of NAFLD. The drug successfully completed Phase I clinical trials, demonstrating a favorable safety profile, and received positive expert evaluation that permitted progression to Phase II.
Recruitment of subjects is being carried out in full compliance with the approved protocol and all applicable regulatory requirements.
Clinical research in gastroenterology and hepatology remains one of the priority areas in ACCELLENA’s portfolio. The company’s extensive expertise in metabolic liver diseases allows it to manage the project throughout all stages — from planning and regulatory support to biometric analysis and preparation of the final clinical study report.
