Albireo Reports Q4 and Year-End 2020 Financial Results and Business Update
February 25, 2021 at 08:00 AM EST
– NDA and MAA for odevixibat accepted, on track for anticipated H2 21 launch –
– Announces odevixibat co-promotion agreement with Travere, a leading rare disease company –
– ASSERT global pivotal Phase 3 trial in Alagille syndrome initiated and enrolling –
– BOLD global pivotal Phase 3 study in biliary atresia initiated and enrolling –
– Pipeline expansion with two new lead compounds in adult cholestatic and viral liver diseases –
- Company to host a conference call and webcast today at 10:00 a.m. ET –
BOSTON, Feb. 25, 2021 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq: ALBO), a clinical-stage rare pediatric liver disease company developing novel bile acid modulators, today provided a business update and reported financial results for the fourth quarter and year ended December 31, 2020.
“2020 was a tremendous year as we delivered on several key milestones, including announcement of positive results from our pivotal PEDFIC 1 Phase 3 study in PFIC patients, completion of regulatory filings in the U.S. and EU in record time, and initiation of two additional pivotal Phase 3 studies in Alagille syndrome and biliary atresia,” said Ron Cooper, President and Chief Executive Officer of Albireo. “We anticipate 2021 to be a similar year of significant accomplishments with the planned approval and commercialization of odevixibat in the U.S. and EU, issuance of our priority review voucher, enrollment advancing in our Phase 3 trials and fully characterizing our two new bile acid modulators with novel MOAs.”
Recent and Upcoming Highlights
Fourth Quarter 2020 Financial Results
Financial Results for the Year Ended December 31, 2020
Odevixibat also been granted Orphan Designation, as well as access to the PRIority MEdicines (PRIME) scheme for the treatment of PFIC. The EMA’s Pediatric Committee has agreed to Albireo’s odevixibat Pediatric Investigation Plans for PFIC and biliary atresia. In addition to PFIC, odevixibat has Orphan Drug Designations for the treatment of Alagille syndrome, biliary atresia and primary biliary cholangitis. With FDA and EMA regulatory submissions complete, odevixibat has the potential to become the first approved drug treatment for patients with PFIC in the U.S and Europe. The Company anticipates potential regulatory approvals, issuance of a rare pediatric disease priority review voucher and launch in the second half of 2021.
The MAA and NDA filings are supported by results from PEDFIC 1 and PEDFIC 2 Phase 3 studies. PEDFIC 1 was the first and largest, global, pivotal Phase 3 study conducted in PFIC, which evaluated the efficacy and tolerability of odevixibat in reducing pruritus and serum bile acids in a randomized, double-blind, placebo-controlled trial. In the PEDFIC 1 study, odevixibat met both primary endpoints and was well tolerated with very low incidence of diarrhea/frequent bowel movements (9.5% of odevixibat treated patients vs. 5.0% of placebo patients). ir.albireopharma.com/news-releases/news-release-details/albireo-phase-3-trial-meets-both-primary-endpoints-odevixibat. PEDFIC 2 is a long-term, open-label Phase 3 extension study. The Company also provides an Expanded Access Program (EAP) for eligible patients with PFIC in the U.S., Europe, Canada and Australia. Odevixibat is also currently being evaluated in the BOLD Phase 3 trial in patients with biliary atresia, and the global Phase 3 ASSERT trial for ALGS.
Albireo Pharma, Inc.
Albireo Pharma, Inc.