Albireo Pharma Posts Positive Topline Results From Phase 3 Study Of Bylvay In Alagille Syndrome
(RTTNews) - Albireo Pharma, Inc. (ALBO) announced Tuesday 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 and its key secondary endpoint of reduction in serum bile acids (sBAs).
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.
A potent, once-daily, non-systemic ileal bile acid transport inhibitor (IBATi), Bylvay has minimal systemic exposure and acts locally in the small intestine.
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