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LPCN 1148 Phase 2 Study Meets Primary Endpoint in Patients with Cirrhosis
Met primary endpoint: treatment with LPCN 1148 increased L3 skeletal muscle index (L3-SMI) relative to placebo (P 1 in the LPCN 1148 treatment arm relative to
About this update from Lipocine Inc.
[{"type":"text","content":"Met primary endpoint: treatment with LPCN 1148 increased L3 skeletal muscle index (L3-SMI) relative to placebo (P 1 in the LPCN 1148 treatment arm relative to placebo (P More patients on LPCN 1148 reported symptom improvement compared to placebo (P LPCN 1148 was well-tolerated, with AE rates and severities similar to placeboConference call and webcast today at 8:30am ETSALT LAKE CITY, July 27, 2023 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders by leveraging its proprietary platform to develop differentiated products, today 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. Lipocine plans to meet with the FDA to discuss a development path to NDA filing.\n\n \n \n \n \n \n \n\n \n\"We are delighted with the positive results from our Phase 2 study,\" said Dr. Mahesh Patel, President and CEO of Lipocine Inc. \"Managing cirrhosis is a significant unmet medical need with a strong pharmaco-economic rationale. We believe LPCN 1148 is a compelling development opportunity; if approved, we believe it has potential to be the standard of care in managing advanced cirrhosis.\"\nThis Phase 2 proof of concept study is an ongoing randomized placebo-controlled study in sarcopenic male patients with cirrhosis on the liver transplant waitlist. Twenty-nine patients were randomized 1:1 to receive either LPCN 1148 or matching placebo for 24 weeks. At Week 24, the open-label extension stage of the study begins; during this stage all patients receive LPCN 1148. The study's primary endpoint was a change in L3-SMI at week 24. L3-SMI estimates whole body skeletal muscle mass and is the standard for sarcopenia assessment in cirrhosis. Secondary endpoints included rates of decompensation events including hepatic encephalopathy, and participant-reported change in symptoms using the PGI-C scale.\nAll LPCN 1148-treated patients completed Week 24 (n=15), whereas ten of fourteen placebo patients completed Week 24. All LPCN 1148-treated patients had at least one evaluable post-baseline CT scan and are therefore part of the modified intent to treat (mITT) analysis; ten placebo-treated patients had an evaluable post-baseline CT. As prespecified, L3-SMI analysis wa...