Why Lipocine Stock Is Moving Higher Today?

Lipocine Inc LPCN shares are trading higher after the company released topline results from a Phase 2 clinical study of LPCN 1148, an oral candidate under development for the clinical management of cirrhosis. 

This Phase 2 proof of concept study is an ongoing randomized placebo-controlled study in sarcopenic male patients with cirrhosis (scarring) on the liver transplant waitlist. 

The study's primary endpoint was a change in L3-SMI at week 24. L3-SMI estimates whole-body skeletal muscle mass and is the standard for sarcopenia assessment in cirrhosis. 

Secondary endpoints included rates of decompensation events, including hepatic encephalopathy, and participant-reported change in symptoms using the PGI-C scale.

All LPCN 1148-treated patients completed Week 24 (n=15), whereas ten of fourteen placebo patients completed Week 24. 

1148-treated patients experienced significantly fewer cases of hepatic encephalopathy > Grade 1 compared to placebo, despite the two treatment groups having a similar number of patients with a medical history of hepatic encephalopathy. 

Patients who received active treatment reported significant improvement in symptoms as early as Week 4, which persisted through Week 24. 

LPCN 1148 patients showed a significant increase in hemoglobin and trended towards resolving anemia, improving ascites, and reducing the number of days hospitalized. 

CT scans suggest improved muscle quality and reduced visceral and subcutaneous fat with LPCN 1148 therapy.

LPCN 1148 was well-tolerated, with adverse event (AE) rates and severities similar to placebo; no mortality was noted in the LPCN 1148 treatment group. 

Rates of diarrhea and nausea were low and similar in both groups. There were no cases of drug-induced liver injury.

Price Action: LPCN shares are up 17.1% at $5.03 on the last check Thursday.