Mirum Pharmaceuticals Meets Primary Endpoint in Second Phase 3 Trial for Hepatitis D Antibody
By Dr. Zubair Khalid, DVM, MS, PhD ·
Mirum Pharmaceuticals has achieved the primary endpoint in a second late-stage clinical trial of its antiviral monoclonal antibody brelovitug for hepatitis D. The positive result extends the company's clinical success in this indication and positions the drug for a regulatory submission to the U.S. Food and Drug Administration.
The phase 3 study evaluated brelovitug in patients with hepatitis D, a severe form of viral hepatitis. Mirum has now met the primary endpoint in two consecutive late-stage trials for the antibody. The company has not yet disclosed specific efficacy or safety data from the trial.
Hepatitis D is a rare but serious liver disease that occurs only in people already infected with hepatitis B. Co-infection with both viruses accelerates liver damage and increases the risk of cirrhosis and liver cancer. No FDA-approved treatments currently exist specifically for hepatitis D, making new therapeutic options a high unmet need in hepatology and infectious disease.
Source: original report