Albireo's Bylvay Shows Further Evidence Of Sustained, Durable Effect In Pediatric Liver Disease Study
Albireo Pharma Inc (NASDAQ: ALBO) has announced pooled analysis from Phase 3 PEDFIC studies with Bylvay (odevixibat) and advancement in the characterization of A3907 in adult liver disease.
Data will be presented at the EASL International Liver Congress 2021.
Results in children with familial intrahepatic cholestasis (PFIC) from two Phase 3 studies showed that Bylvay was associated with rapid reductions in serum bile acid levels and improved pruritus severity, with durable clinical benefits sustained through 48 weeks of treatment.
The observed safety and tolerability profile of Bylvay was consistent across studies, treatment groups, and doses. No drug-related serious adverse events were reported.
One patient in PEDFIC 1 and 3 patients in PEDFIC 2 treated with Bylvay withdrew due to an adverse event.
There were low gastrointestinal adverse events; treatment-related diarrhea/frequent bowel movements were reported in 10% of Bylvay treated patients in PEDFIC 1 and 5% of placebo-treated patients.
Patients with PFIC who responded to Bylvay treatment had sustained improvements in cholestasis-related parameters over 48 weeks that were not observed to the same extent in treatment non-responders.
The Company will also have a presentation and poster on Phase 1 candidate, A3907, with preclinical data showing efficacy on markers of cholestatic disease.
Price Action: ALBO shares are up 2.21% at $35.03 during the market trading session on the last check Monday.
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