ALBO - Albireo Pharma's odevixibat shows durable response in a rare pediatric liver disease

Albireo Pharma (ALBO) announces new data in progressive familial intrahepatic cholestasis ((PFIC)) confirming statistically significant reductions in serum bile acids (sBAs) and improvements in pruritus for odevixibat, a potent, once-daily, non-systemic ileal bile acid transport inhibitor (IBATi).Full results from Phase 3 PEDFIC 1 study, confirm both U.S. and EU primary endpoints were met.Proportion of positive pruritus assessments (Mean): 53.5?% in Odevixibat (n=42, P-value: 0.004) vs. 28.7% in placebo (n=20).Clinically meaningful improvement in pruritus score: 42.9% in Odevixibat (p-value: 0.018) vs. 10.5% in placebo.Bile acid reduction of 33.3% in Odevixibat compared to 0% in palcebo.Interim results from PEDFIC 2, an open-label Phase 3 extension study, also showed continued treatment effect for sBAs, pruritus, growth and liver parameters across PFIC1, PFIC2 and PFIC3 patients. Across both studies, odevixibat was generally well tolerated, and treatment-emergent adverse events were mostly mild or moderate.The data support near-term regulatory filings in the U.S. and EU.Data will be presented at the AASLD Liver

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Albireo Pharma's odevixibat shows durable response in a rare pediatric liver disease