EX99.1

 

Albireo Reports First Quarter 2017 Financial Results

 

BOSTON — May 10, 2017

— Albireo Pharma, Inc. (NASDAQ:ALBO), a clinical-stage orphan pediatric liver disease company developing novel bile acid modulators, today reported its financial results for the first quarter ended March 31, 2017.

 

Albireo reported a net loss of $6.7 million for the quarter ended March 31, 2017, compared with a net loss of $3.2 million for the corresponding 2016 period. As of March 31, 2017, cash and cash equivalents totaled $20.1 million.

 

“In the first part of 2017, we continued to make significant progress toward our goal of bringing A4250 to children suffering from progressive familial intrahepatic cholestasis (PFIC).  We were delighted to have had clinical data from our Phase 2 study in children with cholestatic liver disease selected for a recent oral presentation at The International Liver Congress 2017,” said Ron Cooper, President and Chief Executive Officer of Albireo. “Following consultation with regulatory authorities in both the United States and Europe, we are currently finalizing the design of our Phase 3 program for A4250, which we plan to initiate in the second half of 2017.”

 

Recent Highlights and Corporate Update

A4250

 

Following meetings with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), Albireo is finalizing the design of a Phase 3 program for A4250 in patients with PFIC with the objective of supporting approval of A4250 in both regions.  Albireo expects to initiate its planned Phase 3 clinical trial of A4250 in patients with PFIC in the second half of 2017.

 

Data from Albireo’s Phase 2 open label, dose-finding clinical trial of A4250 in children with cholestatic liver disease and pruritus were presented in April in the late-breaker session at The International Liver Congress 2017 in Amsterdam.  The data, from the trial’s first five cohorts, showed that four weeks of treatment with A4250 reduced serum bile acid levels in a substantial majority of participating patients, particularly PFIC patients, with improvement in pruritus across multiple assessment scales and a significant correlation between reduction in serum bile acids and reduction in pruritus.  There were no serious adverse events determined to be treatment-related observed in the trial, and most adverse events, including some increased transaminases, were transient.  A4250 exhibited a favorable overall tolerability profile in the trial.

 

Albireo hosted a Key Opinion Leader breakfast meeting focused on rare pediatric liver diseases in New York City in April 2017.

 

Elobixibat

 

Data from a Phase 2 clinical trial of elobixibat in chronic constipation conducted by licensee EA Pharma Co., Ltd. (EA Pharma) in Japan was presented at Digestive Disease Week® 2017.  

 


The following information was filed by Albireo Pharma, Inc. (ALBO) on Wednesday, May 10, 2017 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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