Lipocine Announces Publication in Journal of Endocrinological Investigation Highlighting the Potential of LPCN 1144 in the Treatment of NASH and Hepatic Fibrosis
Lipocine Inc. (NASDAQ: LPCN) announced the publication of preclinical results supporting LPCN 1144's potential in treating non-alcoholic steatohepatitis (NASH) and hepatic fibrosis. The study, featured in the Journal of Endocrinological Investigation, demonstrated LPCN 1144's effectiveness in a high-fat diet-induced NASH rabbit model. Lipocine is advancing LPCN 1144 through clinical trials, with a Phase 2 study ongoing. The company focuses on metabolic and endocrine disorders, with an FDA-approved product pipeline including TLANDO and TLANDO XR.
- Publication of preclinical results supports LPCN 1144's potential in treating NASH.
- Ongoing Phase 2 clinical study for LPCN 1144 indicates progress in development.
- No immediate revenue impact as LPCN 1144 is still in clinical trials.
- Risks associated with FDA approval and clinical trial outcomes remain.
SALT LAKE CITY, March 4, 2021 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced the publication of preclinical results supporting the therapeutic potential of LPCN 1144 in the treatment of and non-alcoholic steatohepatitis ("NASH") and hepatic fibrosis. The results were featured in a paper entitled "Treatment Potential of LPCN 1144 on Liver Health and Metabolic Regulation in a Non–Genomic, High Fat Diet Induced NASH Rabbit Model" (Comeglio et al), published in the Journal of Endocrinological Investigation (https://doi.org/10.1007/s40618-021-01522-7).
About Lipocine Inc.
Lipocine 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: TLANDO, LPCN 1144, TLANDO XR, LPCN 1148 and LPCN 1107. TLANDO, a novel oral prodrug of testosterone containing testosterone undecanoate, has received tentative approval from the FDA for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism, in adult males. LPCN 1144, an oral prodrug of bioidentical testosterone, recently completed a proof-of-concept clinical study demonstrating the potential utility in the treatment of non-cirrhotic NASH. LPCN 1144 is currently being studied in a Phase 2 clinical study. TLANDO XR, a novel oral prodrug of testosterone, originated and is being developed by Lipocine as a next-generation oral testosterone product with potential for once-daily dosing. In a phase 2 clinical evaluation when administered as once daily or twice daily TLANDO XR met the typical primary and secondary end points. LPCN 1148 is an oral prodrug of bioidentical testosterone targeted for the treatment of cirrhosis. LPCN 1107 is potentially the first oral hydroxyprogesterone caproate product candidate indicated for the prevention of recurrent preterm birth and has been granted orphan drug designation by the FDA. For more information, please visit www.lipocine.com.
Forward-Looking Statements
This release contains "forward-looking statements" that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include statements that are not historical facts regarding Lipocine's product candidates and related clinical trials, the timing of completion of clinical trials and studies, the availability of additional data, outcomes of clinical trials of our product candidates, the potential uses and benefits of our product candidates, and our product development efforts. Investors are cautioned that all such forward-looking statements involve risks and uncertainties, including, without limitation, the risk that the FDA will not approve any of our products, risks related to our products, expected product benefits not being realized, clinical and regulatory expectations and plans not being realized, new regulatory developments and requirements, risks related to the FDA approval process including the receipt of regulatory approvals, the results and timing of clinical trials, patient acceptance of Lipocine's products, the manufacturing and commercialization of Lipocine's products, and other risks detailed in Lipocine's filings with the SEC, including, without limitation, its Form 10-K and other reports on Forms 8-K and 10-Q, all of which can be obtained on the SEC website at www.sec.gov. Lipocine assumes no obligation to update or revise publicly any forward-looking statements contained in this release, except as required by law.
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SOURCE Lipocine Inc.
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