Denifanstat achieved statistically significant results on primary and multiple secondary endpoints in a 52-week clinical trial of 168 NASH patients with stage 2 or 3 fibrosis
- Primary efficacy endpoints:
- NASH resolution without worsening of fibrosis with ≥2-point reduction in NAS (NAFLD Activity Score) in 36% of denifanstat-treated patients vs 13% with placebo (p=0.002)
- ≥2-point reduction in NAS without worsening of fibrosis in 52% of denifanstat-treated patients vs 20% with placebo (p=0.0001)
- Multiple secondary endpoints:
- Fibrosis improvement by ≥ 1 stage with no worsening of NASH in 41% of denifanstat-treated patients vs 18% with placebo (p=0.005)
- NASH resolution with no worsening of fibrosis in 38% of denifanstat-treated patients vs 16% with placebo (p=0.002)
- MRI-PDFF decline from baseline ≥30% (responders) in 65% of denifanstat-treated patients vs 21% with placebo (p