Gannex posts midphase data on NASH asset at center of trade secret row

Gannex posts midphase data on NASH asset at center of trade secret row

Gannex Pharma has taken a peek at phase 2 data on its nonalcoholic steatohepatitis (NASH) prospect. The Ascletis Pharma subsidiary linked the THRβ agonist to significant reductions in liver fat and pointed to findings that it sees providing an edge over Madrigal Pharmaceuticals and Viking Therapeutics.

One year ago, Viking accused Ascletis of stealing trade secrets to support the development of a drug candidate to rival its NASH prospect VK2809. That dispute rumbled on throughout last year, during which time Gannex continued to work toward midphase data on the molecule at the center of the row. Tuesday, Gannex revealed interim results from the first 42 patients enrolled in the study.

The biotech saw 55.0% and 68.2% mean relative reduction in liver fat from baseline on the low and high doses of ASC41 at week 12, versus a 13.1% decline in the placebo group. The differences versus placebo were statistically significant.

Gannex’s results suggest ASC41 can hold its own against Viking’s VK2809, although the small size of the interim cohort and challenges of cross-trial comparisons make it hard to draw firm conclusions. Viking’s phase 2b linked VK2809 to a 51.7% mean relative reduction in liver fat, compared to a 3.7% dip in the placebo cohort.

The median relative change in liver fat and percentage of patients with a 30% or greater reduction were higher at the most effective dose of ASC41 than in Viking’s trial, again with the caveat about cross-trial comparisons. Gannex also shared data on liver inflammatory biomarkers, lipids and adverse events. No patients on ASC41 experienced grade 3 or greater treatment-emergent adverse events.

In a statement, Ascletis CEO Jinzi Wu highlighted reductions in the liver enzymes ALT and AST as a way that ASC41 is differentiated from “other THRβ agonists currently at clinical or registration stages.” The big tests are still to come, though, with Gannex yet to show its prospect improves or steadies steatohepatitis and fibrosis, the endpoints that matter most to the FDA.

Shares in Ascletis fell 11% to 1.30 Hong Kong dollars ($0.17) in the aftermath of the data drop.

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