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Positive Topline Clinical Results Support Streamlined Development Pathway for LPCN 1154, Lipocine's Oral Candidate for Rapid Relief of Depression
Identified dosing regimen that enables reliance on a single confirmatory pivotal pharmacokinetic (PK) study to establish efficacy for postpartum depression
About this update from Lipocine Inc.
[{"type":"text","content":"Identified dosing regimen that enables reliance on a single confirmatory pivotal pharmacokinetic (PK) study to establish efficacy for postpartum depression (PPD) and support NDA submissionLPCN 1154 treatment was well-tolerated with no hypoxia or sedation-related adverse eventsLipocine plans to initiate the confirmatory pivotal PK study in 2H 2023 Conference call and webcast today at 8:30am ETSALT LAKE CITY, May 16, 2023 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), today announced positive topline results from a pilot clinical PK bridge study of LPCN 1154 (oral brexanolone) with a comparator, IV brexanolone. The pilot study is an important step in Lipocine's ongoing program to develop LPCN 1154 for PPD. Lipocine is a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders by leveraging its proprietary platform to develop differentiated products. \n\n \n \n \n \n \n \n\n \nPPD is a major depressive disorder with onset either during pregnancy or within four weeks of delivery, with symptoms persisting up to 12 months after childbirth. LPCN 1154 is targeted to be a differentiated oral option with rapid-onset, robust efficacy, and short treatment duration as a mono or add-on therapy for patients with unresolved depression symptoms.\nStudy Design and Results\nThe pilot PK bridge study was an open label, randomized, partial crossover study in healthy postmenopausal women. The primary objective of the study was to compare the PK (AUC∞ and Cmax) of two LPCN 1154 oral multi-dose regimens (DR 1: dosing regimen 1 for 3.5 days, DR 2: dosing regimen 2 for 2.5 days) and a continuous IV infusion dosing regimen of brexanolone (per label for 2.5 days, up to 90 µg/kg/hr), to inform the dose selection for the planned confirmatory pivotal PK registration study. The secondary objective was to evaluate the safety and tolerability of multidose regimens of LPCN 1154. The study enrolled a total of twelve participants and was conducted at a single phase 1 unit in the US.\nRatios (%) of geometric mean - LPCN 1154 regimens vs IV brexanolone regimens:\nPK Parameter\nDR 1 vsIV 60 µg* \nDR 1 vsIV 90 µg \nDR 2 vsIV 60 µg* \nDR 2 vsIV 90 µg \nAUC∞\n98 %\n77 %\n106 %\n83 %\nCmax\n114 %\n68 %\n134 %\n79 %\n60 µg and 90 µg refer to the maximum dose in the IV regimen (60 µg/kg/hr and 90 µg/kg/hr). *Interpolated from 90 µg/kg/hr IV infusi...