FibroGen Misses Primary Endpoint in Phase 3 Clinical Study in Duchenne

  FibroGen, Inc.,  (NASDAQ: FGEN) today announced topline data from the Phase 3 LELANTOS-2 trial of pamrevlumab for the treatment of ambulatory patients with Duchenne muscular dystrophy (DMD) on background systemic corticosteroids. The study did not meet the primary endpoint of change in the North Star Ambulatory Assessment (NSAA) total score from baseline to week 52 (placebo-corrected mean difference -0.528 points; 95% CI -2.308 to 1.251; p=0.5553). Secondary endpoints measured by change from baseline at week 52 in 4-stair climb velocity, 10-meter walk/run test, time to stand, time to loss of ambulation, and proportion of patients with greater than 10 seconds in the 10-meter walk/run test were also not met.

https://www.biospace.com/article/releases/fibrogen-announces-topline-results-from-lelantos-2-a-phase-3-clinical-study-of-pamrevlumab-in-ambulatory-duchenne-muscular-dystrophy/