- LPCN 1144 was well tolerated over 72-week exposure with no observed safety signals
- Liver injury markers were reduced and maintained with extended LPCN 1144 treatment
- Observed liver histology improvements support further development
SALT LAKE CITY, May 12, 2022 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology to develop innovative products to treat neuroendocrine and metabolic disorders, announces positive topline results from its Open Label Extension study, OLE. LPCN 1144 comprises an orally delivered prodrug of testosterone.
Twenty-five subjects were enrolled (OLE Safety Set, OLE-SS) of whom 16 subjects from LiFT study continued LPCN 1144 treatment for additional 36 weeks (total of 72 weeks) and nine subjects initiated LPCN 1144 treatment for 36 weeks after placebo run-in for 36 weeks in the LiFT study. The OLE-SS were evaluated for safety and tolerability of LPCN 1144, as well as overall subject health at weeks 6, 12, 24, and 36 of OLE treatment. Twenty-three subjects completed the study, and one subject discontinued due to a non-drug related treatment emergent adverse event (TEAE). Six subjects (OLE Biopsy Set, OLE-BS) elected to have an optional liver biopsy at the end of the OLE at week 72.
LPCN 1144 was well tolerated over 72-week exposure with no observed safety signals
In the OLE-SS, the frequency and severity of TEAEs were comparable to those observed in the LiFT study. There were no reported cases of cardiovascular events, thromboembolic events, hepatocellular carcinoma, or drug induced liver injury ("DILI"). Weight change from baseline was minimal and comparable to the LiFT results. A GI adverse event was reported in one subject, and pedal edema was also reported in one subject, neither of which were considered related to study drug. Additionally, no clinically meaningful changes in lipids were observed.
Liver injury markers were reduced significantly (p