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Lipocine Announces Financial Results for the Second Quarter Ended June 30, 2024
SALT LAKE CITY, Aug. 8, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to
About this update from Lipocine Inc.
[{"type":"text","content":"SALT LAKE CITY, Aug. 8, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced financial results for the second quarter ended June 30, 2024 and provided a corporate update.\n\n \n \n \n \n \n \n\n \nLPCN 1154 for Postpartum Depression (PPD)\nIn June 2024, Lipocine announced positive topline study results from the NDA enabling study of LPCN 1154. LPCN 1154 treatment was well tolerated with no sedation nor somnolence events observedThe Company is targeting NDA submission for LPCN 1154 by the end of the fourth quarter of 2024LPCN 1154, oral brexanolone, is being developed as a 48-hour oral dosing duration treatment for treatment of postpartum depression. It is targeted to be a highly effective, fast-acting and outpatient treatment optionLPCN 2401 for Chronic Weight Management\nIn April 2024, the Company announced positive results from the multi-center perspective, blinded Phase 2 study evaluating LPCN 2401 in participants with obesity (BMI ≥30) and participants with BMI ≥27 with at least one weight-related comorbidityLPCN 2401 treatment resulted in significant improvements in body composition through increased lean mass (LM) or fat free mass (FFM) and bone mineral content in addition to decreased fat mass (FM) and android fat. LPCN 2401 was well-tolerated; adverse events (AEs) including GI events were similar to placebo with no muscle spasm reportedLPCN 2401 has potential for use in combination with incretin mimetics (GLP-1/GIP agonists) including amplification of GLP-1R insulinotropic actions supported by studies demonstrating the role of the androgen receptor agonist in regulation of GLP-1R. Target benefits of LPCN 2401 in combination with GLP-1 agonists include improved body composition with quality weight loss while attenuating lean mass loss, a serious unmet need, and quality fat loss through appreciable abdominal fat loss. LPCN 2401 could also be potentially used as monotherapy post discontinuation of GLP-1 agonist to manage weight/fat regain and durability of diabetes remissionLipocine plans to meet with FDA to discuss the further development of LPCN 2401 as an aid to weight management interventionsLPCN 1148 for Management of Cirrhosis\nIn June, results from a Phase 2 study evaluatin...