EX99.1

Albireo Reports 2016 Financial Results

 

Promising Phase 2 data for A4250 in pediatric cholestatic liver disease

Initiation of A4250 Phase 3 trial planned for 2H 2017

JNDA filing for elobixibat by licensee EA Pharma

Consummation of business combination to become NASDAQ listed

Conference call today at 8:30 a.m. ET

 

 

BOSTON — March 14, 2017

— Albireo Pharma, Inc. (NASDAQ: ALBO), an orphan pediatric liver disease company developing novel bile acid modulators, today announced financial results for the year ended December 31, 2016.

 

Albireo reported a net loss of $16.3 million for the year ended December 31, 2016, compared with a net loss of $6.8 million for 2015. As of December 31, 2016, cash and cash equivalents totaled $29.9 million.

 

“2016 was a transformative year for Albireo, as we generated promising Phase 2 data for our lead product candidate, A4250, in children with cholestatic liver disease and successfully became a publicly traded company listed on NASDAQ,” said Ron Cooper, President and Chief Executive Officer of Albireo.  “As we begin 2017, we are engaging with the FDA and EMA to finalize the design for our planned Phase 3 trial of A4250 in children with progressive familial intrahepatic cholestasis, a rare and highly debilitating genetic liver disorder, which we expect to begin in the second half of the year.”

 

Recent Highlights and Corporate Update

A4250

Albireo disclosed preliminary data from the first five cohorts of its ongoing Phase 2 clinical trial in children with cholestatic liver disease and pruritus, which showed that A4250 reduced serum bile acid levels in a substantial majority of participating patients, particularly progressive familial intrahepatic cholestasis (PFIC) patients, with improvement in pruritus across multiple assessment scales and a significant correlation between reduction in serum bile acids and reduction of pruritus.  In addition, no treatment-related serious adverse events have been observed in the trial to date, with A4250 being generally well tolerated.

 

Albireo is engaging with regulatory authorities in the United States and Europe with the objective of designing a coordinated Phase 3 program in patients with PFIC to support the potential approval of A4250 in both regions.  Albireo met with the U.S. Food and Drug Administration (FDA) in the first quarter of 2017, plans to meet with the European Medicines Agency (EMA) in the second quarter of 2017 and expects to initiate its planned Phase 3 trial of A4250 in patients with PFIC in the second half of 2017.

 

The EMA granted access to its PRIority MEdicines (PRIME) program to A4250 for the treatment of PFIC.

 

 


The following information was filed by Albireo Pharma, Inc. (ALBO) on Tuesday, March 14, 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-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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