US FDA Fast Tracks Lipocine's LPCN 1148 for Sarcopenia in Liver Cirrhosis

Lipocine Inc., a biopharmaceutical company utilizing its own technology platform to enhance therapeutics via efficient oral delivery, reported that the US Food and Drug Administration (FDA) has awarded Fast Track Designation to LPCN 1148 for treating sarcopenia in individuals with decompensated cirrhosis. LPCN 1148, an oral prodrug of bioidentical testosterone, was recently investigated in a proof-of-concept (POC) phase 2 trial involving patients with decompensated cirrhosis. LPCN 1148 treatment in the POC study enhanced sarcopenia and related clinical results. LPCN 1148 aims to be a "First in Class" product candidate featuring a unique mechanism of action for the treatment of cirrhosis.

"We are excited the FDA has recognized that sarcopenia in patients with cirrhosis is a serious condition and that LPCN 1148 has the potential to provide clinical benefits for these patients where no therapy currently exists," said Dr. Mahesh Patel, president and chief executive officer of Lipocine. "We are encouraged that the positive primary endpoint results from our successful proof-of-concept study were recognized by the FDA as evidence of clinical effectiveness of LPCN 1148 in improving sarcopenia in patients with cirrhosis."

Cirrhosis is a terminal liver disease with multiple causes, including alcoholic liver disease, chronic viral hepatitis, nonalcoholic fatty liver disease, and primary cholangitis. Complications of cirrhosis involve decompensatory incidents like hepatic encephalopathy caused by systemic ammonia accumulation, variceal hemorrhaging, and ascites, necessitating repeated hospital stays. Furthermore, several patients show signs of sarcopenia (reduced muscle mass).