Albireo completes full patient enrollment in Phase 2 elobixibat trial
Category: #health  By Saipriya Iyer  Date: 2020-03-12
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Albireo completes full patient enrollment in Phase 2 elobixibat trial

Albireo Pharma, Inc., a clinical stage biopharmaceutical company, has recently announced the completion of full patient enrollment in the Phase 2 clinical trial of elobixibat.

Elobixibat is a once-daily, first-in-class, orally available IBAT (ileal bile acid transporter) inhibitor for treating NASH (nonalcoholic steatohepatitis) and NAFLD (nonalcoholic fatty liver disease). NAFLD patients can further advance to NASH, with a 10-fold greater liver-related mortality risk. According to the company’s estimates, 9 million people in the U.S. and 10 million in the EU are likely to be affected by NASH, with no approved pharmacologic treatment. Furthermore, over 25% of the world’s population is susceptible to NAFLD.

Albireo is expected to announce the topline trial results by mid-2020. The results of the 2nd trial with elobixibat among NASH/NAFLD patients, which is sponsored by EA Pharma (its Japanese partner and exclusive licensee of elobixibat), are anticipated by 2020 end or early 2021. These proof-of-concept trials are designed to evaluate the improvements combination in cardiovascular risk and liver function parameters with favorable patients’ gastrointestinal tolerability profile.

As per Albireo’s President and CEO, Ron Cooper, the company’s preclinical and clinical data from the Phase 1 clinical NASH/NAFLD trial using elobixibat have indicated a strong rationale for modulation of bile acid by IBAT inhibition. The approach could assert a positive impact on a combination of several parameters such as once-daily oral dosing, favorable tolerability profile, liver fibrosis & elevated bile acids, liver inflammation, glucose, and lipids.

Mr. Cooper further added that Albireo is anticipating successful results of the clinical NASH/NAFLD trial, which could pose as a novel therapeutic approach with safety profile as monotherapy or combination therapy to meet the unmet clinical needs of patients. The recent program also opens up significant partnering opportunities to the company.

Additionally, an investigator-sponsored clinical trial has been sponsored by EA Pharma in Japan and other Asian countries. The 16-week trial is expected to enroll 100 patients suffering from NASH and NAFLD to randomized, once in a day 10mg elobixibat dose, bile acid sequestrant cholestyramine, a cholestyramine and elobixibat 10mg combination or placebo.

Source credit:

http://ir.albireopharma.com/news-releases/news-release-details/albireo-completes-enrollment-phase-2-study-elobixibat-nashnafld



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Saipriya Iyer

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Saipriya Iyer

Saipriya Iyer develops content for Market Size Forecasters, Algosonline, and myriad other platforms. A computer engineer by profession, she ventured into the field of writing for the love of playing with words. Having had a previous experience of 3 years under her bel...

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