Positive Outcomes in Phase 2 Cirrhosis Study for LPCN 1148 at 52 Weeks

Lipocine Inc., a biopharmaceutical firm, has announced positive results from their Phase 2 clinical study of LPCN 1148, an oral drug developed for managing cirrhosis, particularly focusing on preventing recurrence of hepatic encephalopathy (HE) and treating sarcopenia. This candidate seeks to become a "First in Class" product with a unique mechanism of action. Lipocine plans to discuss further development with the FDA for an NDA filing.

The Phase 2 study was a randomized, placebo-controlled trial involving male patients with cirrhosis and sarcopenia. These participants, who were awaiting liver transplants, were divided into two groups in Stage 1: one receiving LPCN 1148 and the other a placebo for 24 weeks. Stage 2 allowed all participants to receive LPCN 1148. The primary goal was to assess the change in the L3-Skeletal Muscle Index (L3-SMI), an estimate of skeletal muscle mass, at Week 24. Secondary objectives included examining the rates of hepatic encephalopathy and the safety and tolerability of LPCN 1148.

Results from the study were promising. At Week 24, participants treated with LPCN 1148 showed a significant increase in L3-SMI of 8.8%, sustained through Week 52. Those initially on placebo who switched to LPCN 1148 observed marked muscle mass increases by Week 36, which persisted through Week 52. Moreover, LPCN 1148 treatment led to fewer recurrent hepatic encephalopathy events and extended the average time to the first OHE event, suggesting improved clinical outcomes.

The study's safety profile indicated that LPCN 1148 was well-tolerated, with adverse event rates and severity comparable to placebo. Participants on LPCN 1148 experienced fewer hospital days and shorter hospital stays overall. The study included measurements at baseline and at 12, 24, 36, and 52 weeks, ensuring consistent monitoring of participant health and response to the treatment.

LPCN 1148 comprises testosterone dodecanoate, acting as an androgen receptor agonist. Its multifaceted mechanism aims to bring potential benefits in managing cirrhosis and its related complications.

This announcement comes with a significant context in the management of cirrhosis. Cirrhosis, a late-stage liver disease, has various origins, including chronic alcohol use, viral hepatitis, and nonalcoholic fatty liver disease. It often leads to severe complications like hepatic encephalopathy and sarcopenia, leading to frequent hospitalizations and poor quality of life for patients awaiting liver transplants. With over 382,000 patients diagnosed with decompensated liver cirrhosis in the U.S., there remains a dire need for effective treatment options beyond liver transplantation.

Dr. Arun J. Sanyal and Dr. Jennifer Lai, both noted experts in liver diseases, expressed optimism about the trial results. They emphasized the promising impact of LPCN 1148 on muscle mass and clinical outcomes, highlighting the potential benefits for patients with advanced cirrhosis.

Lipocine's ongoing efforts and the data emerging from their clinical trials underscore the potential of LPCN 1148 as a future treatment standard for managing cirrhosis and associated complications. Further studies are anticipated to fully explore the benefits and risks in this patient population, possibly addressing a substantial unmet medical need.