Hepion Reports Results of CRV431 in P-IIa AMBITION Trial for the Treatment of NASH
Shots:
- The P-IIa AMBITION study assessing CRV431 (75/ 225mg- qd- PO given as soft gelatin capsules) vs PBO to presumed F2 and F3 NASH patients for 28days- followed by a 14-day observation period for safety
- The study met its 1EPs i.e. safety- tolerability & PK with no SAEs at both doses while some patients experienced mild AEs- reductions in liver transaminases indicate dose-related improvements in NASH biomarker- decrease ALT AUCs with increase dose indicating a positive dose-response
- The company plans to initiate the P-IIb ASCEND-NASH trial in 2021 to evaluate CRV431 in biopsy-proven NASH patients with advanced fibrosis
Ref: Globe Newswire | Image: Hepion Pharma
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