Enanta Pharmaceuticals (NASDAQ:ENTA) announces positive results from a Phase 2a clinical trial, ARGON-1, evaluating EDP-305 in patients with nonalcoholic steatohepatitis (NASH).
The study met the primary endpoints of safety and the change in ALT levels (liver enzyme biomarker of liver stress/damage) at week 12. Specifically, ALT levels dropped 28 U/L in the EDP-305 2.5 mg arm compared to 15 U/L in the control arm (p=0.049).
There was also a statistically significant reduction in liver fat content as measured by the proportion (45%) of participants who responded (liver fat reduction of at least 30%), a secondary endpoint.
On the safety front, most treatment-emergent adverse events were mild or moderate. The most common were pruritis (itchy skin), GI distress, headache and dizziness. The pruritis effect appeared dose-related, with a 51% rate in the 2.5 mg arm versus 10% in the 1.0 mg arm. There was also a modest increase in lipids compared to control.
EDP-305 is a Farnesoid X Receptor (FXR) agonist also under development for primary biliary cholangitis. The company says it represents a new class of FXR agonists designed to take advantage of increased binding interactions with the receptor.
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