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Lipocine Announces FDA Grants Fast Track Designation to LPCN 1144 for Treatment of Non-Cirrhotic NASH
SALT LAKE CITY, Nov. 4, 2021 /PRNewswire/ -- Lipocine Inc. (LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders,
About this update from Lipocine Inc.
[{"type":"text","content":"SALT LAKE CITY, Nov. 4, 2021 /PRNewswire/ -- Lipocine Inc. (LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that the U.S. Food and Drug Administration (\"FDA\") has granted Fast Track Designation to LPCN 1144 as a treatment for non-cirrhotic non-alcoholic steatohepatitis (\"NASH\"). LPCN 1144, an oral prodrug of bioidentical testosterone, was recently studied in the Liver Fat intervention with oral Testosterone (\"LiFT \") Phase 2 paired biopsy clinical study in patients with confirmed NASH. Treatments with LPCN 1144 in the LiFT clinical study resulted in robust liver fat reduction, assessed by magnetic resonance imaging, proton density fat fraction (\"MRI-PDFF\") technique, and showed improvement of liver injury markers with no observed tolerability issues. Additionally, key secondary endpoint results after 36 weeks of treatment in the LiFT clinical study demonstrated that treatments with LPCN 1144 met the NASH resolution regulatory endpoint, showed positive effects in appendicular lean mass and whole-body fat mass and continued to show substantial reductions in markers of liver injury compared to placebo.\n\n \n \n \n \n \n \n\n \n\"The granting of Fast Track Designation represents an important recognition by the FDA of LPCN 1144's potential to address a significant unmet need in the treatment of NASH,\" said Dr. Mahesh Patel, Chairman, President and Chief Executive Officer of Lipocine. \"We believe the Fast Track Designation will enable us to work closely with the FDA on our development program for NASH, including the design of the Phase 3 program.\" \nThe Fast Track program is designed to accelerate the development and expedite the review of products, such as LPCN 1144, which are intended to treat serious diseases and for which there is an unmet medical need. Fast Track designation lends eligibility for some, or all, of the following:\nMore frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers Eligibility for Accelerated Approval and Priority Review if relevant criteria are met Rolling Review, which means that a drug company can submit completed sec...