- Albireo Pharma Inc ALBO announced 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 trial met its primary endpoint of improvement in pruritus and its key secondary endpoint of reduction in serum bile acids.
- Statistically significant improvements in multiple sleep parameters were observed as early as week 1-4 compared to patients on placebo, with continued improvement through week 24.
- Bylvay (odevixibat) is the first drug approved in the U.S. for pruritus in patients three months and older in all progressive familial intrahepatic cholestasis.
- There were no patient discontinuations, and Bylvay was well tolerated, with low rates of drug-related diarrhea (11.4% vs. 5.9% placebo).
- The company continues to enroll patients in the Phase 3 BOLD study in biliary atresia. Enrollment is expected to conclude by the end of this year. Topline data is planned for 2024.
- Albireo has engaged in discussions with the FDA and European Medicines Agency about the Phase 3 study design. Both have indicated that a successful single study would be sufficient for approval. The company plans to submit regulatory filings in the U.S. and EU immediately.
- Price Action: ALBO shares are up 7.96% at $22.10 on the last check Tuesday.
© 2023 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.