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Lipocine Announces Financial Results for the Full Year Ended December 31, 2023
SALT LAKE CITY, March 7, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System ("CNS")
About this update from Lipocine Inc.
[{"type":"text","content":"SALT LAKE CITY, March 7, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (\"CNS\") disorders, today announced financial results for the year ended December 31, 2023 and provided a corporate update.\n\n \n \n \n \n \n \n\n \nNeuroactive Steroids\nLipocine announced positive topline results from a pharmacokinetics (\"PK\") pilot bridge study of LPCN 1154 (oral brexanolone). Lipocine is developing LPCN 1154 for postpartum depression (\"PPD\")The bridge study results demonstrated comparative pharmacokinetics of LPCN 1154 to an approved IV infusion brexanoloneThe study identified a dosing regimen of LPCN 1154 to be tested in a single confirmatory pivotal PK study required for NDA filingLPCN 1154 treatment was well-tolerated with no hypoxia or sedation-related adverse eventsThe Company completed a successful meeting with the U.S. Food and Drug Administration (\"FDA\") during which it confirmed with the FDA its proposal for a 505(b)(2) NDA filing based on a single pivotal study comparing exposure of LPCN 1154 with the approved IV infusion of brexanolone. The use of exposure parameters and criteria to assess comparable exposure to IV infusion brexanolone was also agreed uponIn January 2024, Lipocine completed a single arm PK study (N=8) utilizing the \"to be marketed\" LPCN 1154 formulation and target dosing regimen. PK exposure results of the scaled-up formulation were consistent with the PK performance of the formulation evaluated in the pilot study. The study results confirm the 48-hour dosing regimen for the planned pivotal PK studyThe company anticipates beginning the LPCN 1154 pivotal study in Q1 '24. Top line results from the study are expected by the end of Q2 '24. Assuming the study meets expectations, the company plans to file an NDA at the end of Q4 '24Lipocine has identified a lead neuroactive steroid candidate for the management of essential tremor and is planning to submit a protocol for a proof-of-concept phase 2 study for Essential Tremor (\"ET\") in the first half of 2024LPCN 1148\nLipocine announced positive topline results from its Phase 2 proof-of-concept (\"POC\") study evaluating LPCN 1148 for the management of decompensated cirrhosisThe study met the primary endpoint: treatment with LPCN 1148 increased L3 skeletal muscle index (L3-SMI) relat...