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Albireo Pharma (Nasdaq: ALBO) has initiated the BOLD Phase 3 clinical trial, the first pivotal trial for pharmacological therapy targeting biliary atresia, a common pediatric cholestatic liver disease. Odevixibat, a bile acid modulator, has orphan drug designation for this condition. The trial aims to enroll around 200 patients globally, assessing the efficacy of odevixibat in prolonging liver function post-Kasai procedure. This trial underscores the urgent need for effective therapies as approximately 70% of biliary atresia patients require liver transplants during childhood.
Albireo Pharma, Inc. (Nasdaq: ALBO) announced a Key Opinion Leader (KOL) call on clinical outcome assessments (COAs) set for June 16th, 2020, at 8:00 am ET. The call will feature Dr. Chad Gwaltney, who will discuss the design and implementation of COAs in clinical trials, emphasizing the importance of patient-reported outcomes. Additionally, Albireo's Chief Medical Officer, Dr. Patrick Horn, will provide insights into the Phase 3 clinical trial of odevixibat for treating progressive familial intrahepatic cholestasis (PFIC). For further details, the public can access a webcast of the event.
Albireo Pharma (Nasdaq: ALBO) reported first-quarter 2020 financial results amidst COVID-19 challenges, with revenues increasing to $1.5 million, up from $0.6 million in Q1 2019. R&D expenses rose to $16.1 million, driven by program costs and increased personnel. The net loss widened to $31.5 million, or $(2.23) per share, compared to a loss of $16.7 million or $(1.39) per share last year. The company is progressing in pivotal trials for PFIC, biliary atresia, and NASH, with topline results expected mid-2020 and cash reserves projected to last into 2021.
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