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First Biopsy Confirmed Nash Patient Dosed In Lipocine LiFT Study Of LPCN 1144
SALT LAKE CITY, Sept. 30, 2019 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine
About this update from Lipocine Inc.
[{"type":"text","content":" SALT LAKE CITY, Sept. 30, 2019 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that the first patient has been dosed in its LiFT (\"Liver Fat intervention with oral Testosterone\") Phase 2 clinical study, a paired-biopsy study in confirmed pre-cirrhotic non-alcoholic steatohepatitis (\"NASH\") subjects. \n\n \n\"The first patient dosing in the LiFT study is an important step in the clinical development of LPCN 1144, a differentiated oral treatment with good chronic tolerability, for NASH,\" stated Mahesh Patel, President and Chief Executive Officer of Lipocine. Patel added, \"Reportedly, a majority of biopsy confirmed male NASH patients have low testosterone levels, a significant result given that LPCN 1144 treatment in an earlier clinical study has demonstrated meaningful liver fat reductions in men with low testosterone.\" \nThe LiFT Phase 2 clinical study is a prospective, multi-center, randomized, double-blind, placebo-controlled multiple-arm study in biopsy-confirmed male NASH subjects with grade F2/F3 fibrosis and a NAFLD Activity Score (\"NAS\") ≥ 4 with a 36-week treatment period. The LiFT clinical study is designed to enroll approximately 75 biopsy confirmed NASH male subjects, randomized into one of three arms (two test arms and one placebo arm) with a 1:1:1 randomization ratio. We currently expect top-line primary end point liver fat reduction data in mid-2020, as measured by MRI-PDFF at 12 weeks, followed by 36-week biopsy data. \nAbout Lipocine\nLipocine Inc. is a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders using its proprietary drug delivery technologies. Lipocine's clinical development pipeline includes four development programs TLANDO, LPCN 1144, TLANDO XR (LPCN 1111) and LPCN 1107. TLANDO, a novel oral prodrug of testosterone containing testosterone undecanoate, is designed to help restore normal testosterone levels in hypogonadal men and currently under USFDA review for marketing approval. LPCN 1144, an oral product of bioidentical testosterone, recently completed a proof-of-concept clinical study demonstrating the potential utility the in treatment of NASH. TLANDO XR (LPCN 1111), a novel oral prodrug of testosterone, originated and is being developed by Lipocine as a...