Friday, February 23, 2018
MYR Pharma GmbH today announced the completion of the 48-week-long active treatment phase in MYR 203 clinical trial, a part of Phase 2b program investigating Myrcludex B in combination with pegylated interferon (PEG INF) in chronic hepatitis Delta (HDV) infection. A total of 60 subjects enrolled into this study in 7 centers in Russia were randomized in four groups to receive PEG INF, Myrcludex B monotherapy, and combinations of PEG INF with two different doses of Myrcludex B, respectively.
Commenting on the announcement, MYR Pharma's Chief Medical Officer Dr. Alexander Alexandrov said: "Myrcludex B was very well tolerated with no SAEs attributed to the study drug, confirming the excellent safety profile of the drug that we observed in previous clinical studies." He further commented: "All patients on the combination therapy have by now completed 48 weeks of treatment. We are currently evaluating efficacy readouts from the study."
"Myrcludex B recently demonstrated encouraging results in cirrhotic and interferon non-responder population in MYR 202 clinical trial. The ongoing MYR 203 study will provide an insight as to whether add-on treatments with Myrcludex B can improve suboptimal outcomes of the current standard-of-care interferon treatment," said Heiner Wedemeyer, MD, Professor at the Essen University Hospital and Chairman of MYR Pharma's Clinical Advisory Board.
The patients in MYR 203 are now undergoing a 24-week follow up period. The company expects to announce the results of the study in the mid-2018.