FDA clears LPCN 1144 investigative NASH therapy for expanded trials

Lipocine received clearance from the FDA to clinically investigate LPCN 1144 in an expanded target population of men with nonalcoholic steatohepatitis, according to a press release.

Previously, investigation of LPCN 1144 was limited to only testing patients with NASH and total testosterone levels lower than 300 ng/dL, the threshold for hypogonadism.

“We are excited about receiving FDA clearance to expand our target patient population in adult NASH males regardless of their hypogonadal status,” Mahesh V. Patel, PhD, chairman, president and CEO of Lipocine, said in the release. “We believe testing in the expanded cleared patient population will be a pioneering and differentiated potential indication for LPCN 1144.”

LPCN 1144 is currently under investigation in a randomized control phase 2 study. Investigators designed the study to assess the therapy potential of LPCN 1144 for NASH by evaluating liver fat changes with magnetic resonance imaging-estimated proton density fat fraction.

Interim results showed a 7.6% absolute reduction of liver fat and a 38% relative mean liver fat reduction compared with baseline. Additionally, previous studies of up to 52 weeks of exposure showed that LPCN-1144 was well-tolerated with no adverse liver enzyme signals or treatment-related severe adverse events.

Reference: www.lipocine.com