Lipocine talks up interim data from small NASH study

Lipocine is working toward 16-week liver fat data. (Database Center for Life Science/CC BY-SA 2.1)

Lipocine has shared interim data from a small clinical trial of its NASH candidate LPCN 1144. Shares in the nanocap biotech shot up more than 100% in premarket trading before falling away somewhat as people dug deeper into the data.

Salt Lake City-based Lipocine framed results from the single-arm, open-label trial as evidence that its oral prodrug of bioidentical testosterone can deliver “meaningful” reductions in liver fat. To make its case, Lipocine singled out nine participants with baseline liver fat of 10% or more from the study of 36 hypogonadal males. Two of the patients were excluded from the analysis due to missing data.

Among the seven people selected for analysis, the baseline mean liver fat was 21%. After eight weeks of treatment, the magnetic resonance imaging, proton density fat fraction technique found relative and absolute mean reductions in liver fat of 7.6% and 38%, respectively.

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Lipocine also looked at how many of the seven patients experienced an absolute reduction in liver fat of 4.1% or more, a figure it selected as another study found that was the mean change in histological responders to a NASH intervention. Six of the seven patients in the analyzed subgroup experienced a 4.1% improvement. Five of the subjects experienced the relative change identified in the other study.

Multiple limitations of the study make it hard to gauge what the data say about the efficacy of the drug. A full picture will only emerge once LPCN 1144 is tested against a control in more patients, but Stephen Harrison was willing to talk up the drug’s prospects on the strength of the available data.

“The interim results strongly suggest the potential benefit of LPCN 1144 therapy for patients with NAFLD and support further study to validate a histopathologic benefit in patients with NASH,” Harrison, medical director at liver trial service provider Pinnacle Clinical Research, said in a statement.

Lipocine will now continue to gather data in the 16-week study.