FX.co ★ Lipocine: LPCN 1148 Meets Primary And Hepatic Encephalopathy Endpoints In Phase 2 Study

Lipocine Inc. has revealed promising primary results from a Phase 2 clinical trial of LPCN 1148, intended for patients with cirrhosis. Both primary and Hepatic Encephalopathy endpoints were satisfactorily attained with an observed enhancement in the Skeletal Muscle Index at 24 weeks, a success sustained through 52 weeks. When patients on placebo were switched to LPCN 1148, an increase in the Skeletal Muscle Index was also seen. Throughout the trial, LPCN 1148 was generally well-received with adverse event rates and severities mirroring those found in Stage 1 with the placebo.

Mahesh Patel, President and CEO of Lipocine Inc, stated, "These results demonstrate that LPCN 1148 treatment can provide considerable benefits for patients with cirrhosis who are sarcopenic and have experienced other severe decompensation events such as Overt Hepatic Encephalopathy." The company now plans to engage with the FDA to strategize a path toward filing for NDA.

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