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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