Hepatera LLC and MYR GmbH, a German company, announced positive results from Phase 2b clinical trials of Myrcludex B in patients with chronic hepatitis В with delta agent. The trials included 120 patients from 15 clinical centers in Russia and Germany.
Myrcludex В demonstrated good safety profile throughout a 24-week period. During the study there were no serious adverse events or early termination of treatment related to the study drug. Patients’ compliance to treatment was extremely high.
All groups of patients on Myrcludex B treatment achieved the primary endpoint, i.e. the decrease of HDV RNA detected using PCR by ≥2log10 in these patients significantly exceeded the relevant figures of the control group. In patients, receiving dose 10 mg, the endpoint was achieved in 76.6% of cases versus 3.3% in the control group. The reduction of HDV RNA median values in the 10 mg treatment group was 2.7log10 versus 0.18log10 in patients of the control group.
A pronounced response to treatment, which was determined by measuring some biochemical parameters, was observed in all Myrcludex B treatment groups and was virtually absent in the control group. 40% of patients in the 10 mg treatment group achieved ALT normalization by week 24 compared to 6.6% in the control group. The median values of ALT in the 10 mg treatment group and in the control group were 43 U/L and 76 U/L, respectively.