Albireo Pharma Inc. (NASDAQ: ALBO) has announced the presentation of analyses of its PEDFIC 1 and PEDFIC 2 trials that evaluated Bylvay in treating progressive familial intrahepatic cholestasis. The company made the presentation during the Digestive Disease Week Annual meeting.
Alibireo presents data on Bylvay studies
Additional data from a preclinical trial were also shared at the symposium, revealing that the company’s experimental dual-acting kidney/ileal and hepatic bile acid inhibitors can greatly improve the excretion of bile acid. The abstracts can be found on the DDW website.
CEO and President of Albireo Ron Cooper said, “The PEDFIC 1 and PEDFIC 2 Phase 3 clinical trials represent the largest body of data ever collected in PFIC, a rare disease that causes tremendous suffering for patients and their families. We’re pleased to share data demonstrating Bylvay’s efficacy on a wide range of all types of PFIC as well as positive impact on all levels of pruritus in PFIC.”
Bylvay is a non-systemic once per day ileal bile acid transport inhibitor (IBATi) that has been authorized in the United States for pruritus treatment in patients older than 3 months with all PFC types.
Bylvay available in the US and Europe
In Europe for, the treatment of all PFIC forms in patients more than six months is premised on the PEDFIC 1 and PEDFIC 2 open-label extension studies. Bylvay is currently available in the United Kingdom and Germany, with more European nations to follow after pricing and coverage clearance.
Co-founder and Chief Scientific Officer of Albireo Jan Mattson said, “The ASBT and NTCP bile acid transporters play important roles in maintaining bile acid homeostasis. This study shows that dual-acting ASBT/NTCP with different selectivity may represent an attractive strategy to reduce bile acid burden in hepatobiliary diseases, reinforcing the potential of our A3907 and A2342 programs as well as our earlier staged novel bile acid modulators.”
The drug is available in a capsule for patients that can swallow it. Alternatively, patients can be open and sprinkle it on food for those unable to swallow capsules, especially pediatric patients.
