Albireo reports positive topline data from phase 3 trial of bylvay® (odevixibat) in alagille syndrome

Boston, oct. 11, 2022 (globe newswire) -- albireo pharma, inc. (nasdaq: albo), a rare disease company developing novel bile acid modulators to treat pediatric and adult liver diseases, today announced positive topline results from the phase 3 assert study evaluating the safety and efficacy of bylvay in alagille syndrome (algs) patients from birth to early adulthood. the global, double-blind, randomized, placebo-controlled trial met its primary endpoint of improvement in pruritus (p=0.002) and its key secondary endpoint of reduction in serum bile acids (sbas) (p=0.001). there were no patient discontinuations and bylvay was well tolerated, with low rates of drug-related diarrhea (11.4% vs. 5.9% placebo). albireo has engaged in discussions with the fda and ema about the phase 3 study design, both have indicated that a successful single study would be sufficient for approval. the company plans to immediately submit regulatory filings in the u.s. and eu.
ALBO Ratings Summary
ALBO Quant Ranking