- Top-line data for a phase 3 trial of Albireo Pharma's ( NASDAQ: ALBO ) Bylvay (odevixibat) in Alagille syndrome showed the candidate met its primary endpoint of significant improvement in pruritus .
- Shares are up 17% in premarket trading.
- It also met a secondary endpoint, reduction in serum bile acids.
- Data showed that in the treatment arm, the reduction in pruritus was 1.69 points based on the PRUCISION Observer-Reported Outcome scratching score (0-4 point scale), from baseline to month 6 compared to a 0.8 point improvement in the placebo group.
- Alagille syndrome is a rare disease characterized by bile buildup in the liver impacting ~25K people worldwide.
- Albireo ( ALBO ) is patients is also examining Bylvay in a phase 3 trial for biliary atresia. Top-line data is anticipated in 2024.
- In the US, Bylvay is already approved for pruritus in patients 3 months and older in all types of progressive familial intrahepatic cholestasis.
- Check out why Seeking Alpha contributor BioSci Capital Partners is bullish on Albireo ( ALBO ).
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Albireo Pharma achieves positive phase 3 top-line results of Bylvay in Alagille syndrome