Skip to main content

Market Overview

Albireo's Bylvay Shows Further Evidence Of Sustained, Durable Effect In Pediatric Liver Disease Study

Share:
Albireo's Bylvay Shows Further Evidence Of Sustained, Durable Effect In Pediatric Liver Disease Study
  • Albireo Pharma Inc (NASDAQ: ALBOhas 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.
 

Related Articles (ALBO)

View Comments and Join the Discussion!

Posted-In: Briefs Liver DiseaseBiotech News Health Care Small Cap FDA General

Don't Miss Any Updates!
News Directly in Your Inbox
Subscribe to:
Benzinga Premarket Activity
Get pre-market outlook, mid-day update and after-market roundup emails in your inbox.
Market in 5 Minutes
Everything you need to know about the market - quick & easy.
Fintech Focus
A daily collection of all things fintech, interesting developments and market updates.
SPAC
Everything you need to know about the latest SPAC news.
Thank You

Thank you for subscribing! If you have any questions feel free to call us at 1-877-440-ZING or email us at vipaccounts@benzinga.com