- Lipocine Inc (NASDAQ:LPCN) has announced topline results from its Open-Label Extension (OLE) study of LPCN 1144, including an orally delivered prodrug of testosterone.
- Twenty-five subjects were enrolled, of whom 16 subjects from the 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 frequency and severity of TEAEs were comparable to those observed in the LiFT study.
- Related: Lipocine, Antares Ink Licensing Pact For Testosterone Replacement Therapy In US.
- There were no reported cases of cardiovascular events, thromboembolic events, hepatocellular carcinoma, or drug-induced liver injury.
- Liver injury markers were reduced relative to baseline during the initial 36 weeks of treatment with LPCN 1144.
- Further, subjects exposed to 72-weeks of LPCN 1144 treatment maintained the mean liver injury marker reductions.
- In the limited number of biopsies, LPCN 1144 treatment showed improved efficacy upon extended treatment, and treatment post-36-week placebo run-in demonstrated efficacy consistent with the LiFT study results.
- Price Action: LPCN shares are down 0.75% at $0.72 during the market session on the last check Thursday.
