BAD HOMBURG, Germany, October 23, 2018 / PRNewswire / -- MYR Pharma today announced that US Food and Drug Administration (FDA) has granted the Breakthrough Therapy designation for its lead compound Myrcludex. The designation is granted in the indication chronic hepatitis delta (HDV) infection. The designation allows to expedite the development and review of drugs intended for the treatment of serious or life-threatening diseases. HDV infection leads to the most severe viral hepatitis, and there is no FDA-approved drug for treatment of this condition.
“Myrcludex was very well tolerated and has shown compelling antiviral activity in clinical trials performed so far" said Alexander Alexandrov, MYR`s Chief Medical Officer. "We are looking forward to working with the agency to accelerate the development program."
Myrcludex is a first-in-class entry inhibitor for treatment of chronic hepatitis B and D infections. The drug inhibits the HBV receptor on the hepatocyte surface and prevents the infection of healthy cells and viral spread within the liver. Myrcludex has received Orphan Designation for treatment of HDV infection from EMA and FDA, PRIME scheme eligibility from EMA, and a breakthrough therapy designation from FDA.
About MYR Pharmaceutical
MYR Pharma is a German clinical stage biotechnology company focused on drugs for the treatment of chronic hepatitis B and D virus infections. The company`s lead compound is currently progressing into Phase 3 studies in the indication chronic HDV infection.