Lipocine Inc. (NASDAQ: LPCN) has released encouraging topline week-36 findings for the Phase 2 proof of concept Liver Fat intervention with oral Testosterone (LiFT) clinical study. LiFT study assessed LPCN 1144 in biopsy-confirmed NASH patients.
LPCN 1144 reduced hepatic fat
There is no approved NASH treatment currently despite NASH being the main liver failure and transplantation cause worldwide. Notably, LPCN 1144 consists of an orally delivered prodrug of endogenous testosterone. In addition, the study enrolled biopsy-confirmed eugonadal r hypogonadal NASH participants with Advanced Fibrosis and steatohepatitis individuals also eligible.
The LiFT study’s primary endpoint was hepatic fat fraction change through MRI-PDFF after 12 weeks of treatment. Also, the secondary endpoints after 36 weeks included histological NASH resolution change or Fibrosis improvement. After 12 weeks of LPCN 1144 treatment, the considerable liver fat reduction was evaluated through MRI-PDFF; thus, the study met the pre-specified endpoint. In addition, there was considerable liver fat reduction relative to the placebo.
Virginia Commonwealth University (VCU) Department of Internal Medicine and VCU Centre for Clinical and Translational Research Education Core Director Arun Sanyal said, “The extent of the LPCN 1144 efficacy results in meeting the NASH resolution regulatory endpoint from the LiFT study is striking with no adverse safety signal. These data strongly support further development of this differentiated novel approach as a treatment of NASH.”
LPCN 1144 is a potential NASH treatment
Lipocine CEO and President Dr. Mahesh Patel said, “We are delighted by the remarkable efficacy results and the overall safety profile of LPCN 1144 in the LiFT study, which we believe demonstrate the potential for LPCN 1144 to be the “best in class” option for treating NASH with a discerning benefit to risk profile as required for a chronic therapy. Additionally, the unique benefits of LPCN 1144 in improving body composition may fulfill an unmet medical need. We look forward to meeting with the FDA regarding the path forward for an accelerated approval and Phase 3 study requirements.”
