- Results from a Phase 1 clinical trial assessing Enanta Pharmaceuticals' (ENTA -0.1%) NASH and PBC candidate EDP-305 showed a favorable safety and pharmacokinetic/pharmacodynamic profile.
- The study enrolled 146 subjects who received at least one single or multiple ascending doses of EDP-305 (n=110) or placebo.
- No serious adverse events were reported and all doses were generally well-tolerated. Treatment-emergent adverse events observed in the multiple ascending dose cohorts were headache and itching in healthy volunteers and constipation and itching in obese subjects presumed to have nonalcoholic fatty liver disease with or without prediabetes or type 2 diabetes.
- Strong FXR target engagement was also demonstrated.
- ECP-305 is a Farnesoid X Receptor (FXR) agonist under development for nonalcoholic steatohepatitis (NASH) and primary biliary cholangitis (PBC). The company says it represents a new class of FXR agonists designed to take advantage of increased binding interactions with the receptor.
- Detailed results will be submitted for presentation at a future medical conference.
- Now read: Enanta Pharma (ENTA) Presents At Cantor Fitzgerald Global Healthcare Conference - Slideshow
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