Bylvay is being evaluated in the ongoing PEDFIC 2 open-label trial (NCT03659916) designed to assess long-term safety and durability of response in a cohort of patients rolled over from PEDFIC 1 and a second cohort of PFIC patients who are not eligible for PEDFIC 1.
Bylvay is also currently being evaluated in the BOLD (NCT04336722) Phase 3 clinical trial in patients with biliary atresia. BOLD, the largest prospective intervention trial ever conducted in biliary atresia, is a double-blind, randomized, placebo-controlled trial which will enroll approximately 200 patients at up to 75 sites globally to evaluate the efficacy and safety of odevixibat in children with biliary atresia who have undergone a Kasai procedure before age three months.
The Company has also initiated the ASSERT (NCT04674761) double-blind, randomized, placebo-controlled global Phase 3 trial of Bylvay in Alagille syndrome to evaluate the safety and efficacy of Bylvay in relieving pruritus in patients with Alagille syndrome.
Bylvay™ (odevixibat) is approved for the treatment of pruritus in PFIC in the U.S. and for PFIC Europe. Elobixibat is approved for chronic constipation in Japan and Thailand. All other drugs and indications are currently investigational.