The Food and Drug Administration (FDA) has granted Fast Track designation to LPCN 1144 for the treatment of noncirrhotic nonalcoholic steatohepatitis (NASH).
LPCN 114 is an oral prodrug of bioidentical testosterone. The designation is supported by data from the phase 2 LiFT study (ClinicalTrials.gov Identifier: NCT04134091), which assessed the efficacy and safety of LPCN 1144 in 56 adult men with biopsy confirmed NASH. Patients were randomly assigned 1:1:1 to receive: twice daily oral dose of 142mg testosterone equivalent (Treatment A), twice daily oral dose of 142mg testosterone equivalent formulated with 238mg of d-alpha tocopherol equivalent (Treatment B), or placebo.
At 12 weeks, results showed LPCN 1144 treatment was associated with a statistically significant reduction in liver fat compared with placebo (primary endpoint; assessed by magnetic resonance imaging proton density fat fraction). At 36 weeks, 46% of the Treatment A group and 69% of the Treatment B group had NASH resolution with no worsening of fibrosis (secondary endpoint) vs 0% of the placebo group (P <.05 and P <.001, respectively).
“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 CEO 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.”
The FDA’s Fast Track designation allows for expedited review of therapies that are meant to treat serious or life-threatening conditions. Generally, the designation is granted to therapies that are expected to have an impact on factors such as survival and daily functioning.
- Lipocine announces FDA grants Fast Track designation to LPCN 1144 for treatment of non-cirrhotic NASH. News release. Lipocine Inc. Accessed November 4, 2021. https://www.prnewswire.com/news-releases/lipocine-announces-fda-grants-fast-track-designation-to-lpcn-1144-for-treatment-of-non-cirrhotic-nash-301416045.html.
- Lipocine’s LPCN 1144 met non-alcoholic steatohepatitis (“NASH”) resolution regulatory endpoint in phase 2 LiFT study. News release. Lipocine Inc. August 25, 2021. Accessed November 4, 2021. https://www.lipocine.com/news-article/lipocines-lpcn-1144-met-non-alcoholic-steatohepatitis-nash-resolution-regulatory-endpoint-in-phase-2-lift-study/.