Lipocine: Positive Topline Results Support LPCN 1144 Development For Regulatory Approval

(RTTNews) - Lipocine Inc. (LPCN) said the topline 36-week results from phase 2 proof of concept LiFT clinical study, NCT04134091, with LPCN 1144 met Non-Alcoholic Steatohepatitis or NASH, resolution regulatory endpoint. The company said it looks forward to meeting with the FDA regarding the path forward for an accelerated approval and phase 3 study requirements.

In the study, both LPCN 1144 treatment arms met with statistical significance the pre-specified histology based regulatory endpoint of NASH resolution with no worsening of fibrosis. LPCN 1144 was well tolerated in the study.

Shares of Lipocine were up 7% in pre-market trade on Wednesday.