Lipocine Inc. (LPCN) reported positive topline results from a Phase 2 clinical study of LPCN 1148 in patients with cirrhosis. The study met primary and Hepatic Encephalopathy endpoints. The increase in Skeletal Muscle Index or SMI observed at week 24 was maintained through 52 weeks. Participants on placebo increased SMI when switched to LPCN 1148. In the study, LPCN 1148 was well-tolerated with AE rates and severities similar to those observed in Stage 1 with placebo.
"These results demonstrate that LPCN 1148 treatment benefits patients with cirrhosis who are sarcopenic and have experienced other serious decompensation events such as Overt Hepatic Encephalopathy," said Mahesh Patel, President and CEO of Lipocine Inc.
The company plans to meet with the FDA to discuss a development path to NDA filing.
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