Lipocine’s LPCN 1148 shows positive results in Phase 2 cirrhosis study

Lipocine announced positive topline results from a Phase 2 clinical study of LPCN 1148. LPCN 1148 is an oral candidate under development for the clinical management of cirrhosis. LPCN 1148 is targeted to be a “First in Class” product candidate with a novel mechanism of action. Lipocine plans to meet with the FDA to discuss a development path to NDA filing. The study’s primary endpoint was a change in L3-Skeletal Muscle Index at week 24. Participants who received LPCN 1148 during Stage 1 had a significant increase in L3-SMI of 4.1 cm2/m2 or 8.8% at Week 24, the primary analysis timepoint, and this increase was maintained through the additional 28 weeks of the study. Placebo participants who began receiving LPCN 1148 saw a marked increase in SMI as early as 12 weeks after therapy initiation and this increase was maintained through Week 52. The average time to first Overt Hepatic Encephalopathy recurrence was longer with LPCN 1148 treatment, at 183 days compared to 35 days for placebo. In this 52-week study, LPCN 1148 was well-tolerated with AE rates and severities similar to those observed in Stage 1 with placebo. Participants experienced fewer serious or severe adverse events when switched from placebo to LPCN 1148. Participants on LPCN 1148 were hospitalized for fewer total days with shorter hospital stays. There were two deaths reported in placebo-treated participants and one in LPCN 1148-treated participants during the study.