Albireo Pharma Overview:
Albireo Pharma is a clinical-stage biopharmaceutical company focused on the development of novel bile acid modulators to treat rare pediatric and adult liver diseases. Albireo has deep expertise in bile acid biology and a pipeline of clinical and pre-clinical programs. Albireo’s lead product candidate, odevixibat, is being developed to treat rare pediatric cholestatic liver diseases with Phase 3 pivotal trials in PFIC, Alagille syndrome and biliary atresia. The Company completed IND-enabling studies for new preclinical candidate A3907 and plans to advance development in adult liver disease. Albireo was spun out from AstraZeneca in 2008 and is headquartered in Boston, Massachusetts, with its key operating subsidiary in Gothenburg, Sweden. The Boston Business Journal named Albireo one of the 2020 Best Places to Work in Massachusetts for the second consecutive year.
The company’s first commercial launch will be odevixibat, which is an investigational product candidate being developed to treat rare pediatric cholestatic liver diseases, including progressive familial intrahepatic cholestasis (PFIC), biliary atresia and Alagille syndrome. A potent, once-daily, non-systemic ileal bile acid transport inhibitor (IBATi), odevixibat acts locally in the small intestine. Odevixibat has the potential to become the first approved pharmacologic treatment for patients with PFIC.
The FDA has granted Priority Review and set a Prescription Drug User Fee Act (PDUFA) goal date of July 20, 2021. Odevixibat previously received Fast Track, Rare Pediatric Disease and Orphan Drug Designations in the U.S. In Europe, the Company has submitted odevixibat for a Marketing Authorization Application (MAA) to the EMA seeking approval in PFIC. Odevixibat is the only IBATi granted accelerated assessment by the EMA. It has 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 ALGS, biliary atresia and PBC. With U.S. and EU regulatory filings in PFIC completed, the Company anticipates potential regulatory approvals, issuance of a rare pediatric disease Priority Review Voucher and launch in the second half of 2021.
Odevixibat is also currently being evaluated in a Phase 3, long-term extension study and two pivotal Phase 3 trials: the ongoing PEDFIC 2 Phase 3 open-label trial in patients with PFIC, the BOLD Phase 3 trial in patients with biliary atresia and the ASSERT Phase 3 trial in ALGS. Albireo is also exploring multiple methods for modulating bile acids to significantly change the bile acid transporter approach in adult liver disease, with two promising new candidates with two different mechanisms of action. The Company will initially focus on primary sclerosing cholangitis (PSC) and primary bilateral cholangitis (PBC) as well as viral cholestatic liver disease, including hepatitis B and D.
Reporting to the Senior Director, Data Management, the Senior Manager will be responsible for establishing and managing study data management activities through management/oversight of CRO partners performing data management activities across multiple clinical programs and therapeutic indications.
What makes this role special:
Albireo Pharma, Inc.
Posted on : 10 days ago
Talent is of no use without opportunity and what’s the use of such opportunities that are not accessible. Here at Jobrino, we believe that the most satisfying careers for professionals are the ones that fully embrace the value of their skills and experience.
Jobrino has helped match prospective candidates with employers from across the professional array. Employers turn to Jobrino to source the career-focused individuals they need to expand and inspire their workforce.