FDA OKs expanded population for Lipocine’s NASH candidate

Lipocine (NASDAQ:LPCN) announces that the FDA has signed off on expanding the target population of adult male NASH patients for LPCN 1144.

Specifically, the agency has waived the limitation of NASH patients with testosterone levels below 300 ng/dL (threshold for hypogonadism).

The company says a recent report suggests that 75% of biopsy-confirmed male NASH patients have total testosterone levels below 372 ng/dL and the degree of liver fibrosis severity is inversely related to free testosterone levels, supporting the rationale of testing LPCN 1144 in NASH patients regardless of their hypogonadal status.

A Phase 2 clinical trial, LiFT, is ongoing.

https://seekingalpha.com/news/3480132-fda-oks-expanded-population-lipocines-nash-candidate-lpcn-1144