NASH - January 2021
CAR-T Digest - August 2020
CAR-T Digest - August 2020
CAR-T Digest - August 2020
CAR-T Digest - August 2020
NASH - January 2021
Lipocine presented encouraging Phase 2 LiFT study results of LPCN 1144
12 Jan 2021
Lipocine – LPCN 1144 (Androgen receptor agonist, Phase 2)
- The Phase 2 LiFT trial is a randomized, double-blind, placebo-controlled 36-week treatment of adult men with NASH
- Arm A is a twice daily oral dose of 142 mg testosterone equivalent
- Arm B is a twice daily oral dose of 142 mg testosterone equivalent formulated with 217 mg of d-alpha tocopherol equivalent, and the third arm is twice daily matching placebo
- Results:
- Treatments with LPCN 1144 post 12 weeks of treatment resulted in robust liver fat reduction, assessed by MRI-PDFF, and showed improvement of liver injury markers with no observed tolerability issues
- Inclusion of d-alpha tocopherol formulated with the testosterone prodrug resulted in additional liver benefits, notably improved key liver markers without compromising tolerability
Responders with > 30% Relative Reduction in Liver Fat at Week 12, Intent to Treat Dataset (n=56) | ||
Treatment | Responder (% of subjects) | p value vs placebo |
A (N=18) | 66.7 | 0.0058 |
B (N=19) | 63.2 | 0.0026 |
Placebo (N=19) | 15.8 | – |
- During the 12 weeks of treatment, the observed rates and severity of TEAEs in both the treatment arms were comparable to the placebo arm
- Three subjects in the placebo group and one subject in the combined treatment arms discontinued study drug due to TEAEs
- Subjects will be given access to LPCN 1144 through an open label extension study (NCT04685993), which will enable Lipocine to collect additional data for up to a total of 72 weeks of therapy
LPCN 1144 shows robust liver fat reduction in 66.7% patients with no safety concerns
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CI Scientists Remarks:
- Lipocine uses its proprietary solubilization technology to effectively reposition and deliver oral water insoluble drugs to improve patient compliance
- Rationale: Historical data showed ~75% biopsy confirmed NASH patients had decreased testosterone levels. LPCN 1144 is an oral prodrug of bioidentical testosterone
- This top-line data established the first proof-of-concept for LPCN 1144 in improving both liver fat and markers of liver injury in NASH patients
- Lipocine plans to report 36-week biopsy data in mid-2021
– Akshat Gulati, CI Scientists