01/23/2020 | Press release | Distributed by Public on 01/23/2020 07:40
BOSTON, Jan. 23, 2020 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq: ALBO), a clinical-stage orphan pediatric liver disease company developing novel bile acid modulators, commemorates the first International Alagille Awareness Day on January 24, 2020, acknowledging pediatric hepatologist and researcher Dr. Daniel Alagille, who first characterized the syndrome. Alagille syndrome (ALGS)is a rare genetic disorder associated with liver, heart, eye and skeletal abnormalities without an approved pharmacological treatment.
'International Alagille Syndrome Awareness Day brings this condition to the forefront and it is an occasion to acknowledge and celebrate our ALGS families,' said Cher Bork, Executive Director of Alagille Syndrome Alliance (ALGSA). 'We are grateful to our partners like Albireo Pharma, who have taken time to meet families in our community, and who are committed to supporting our efforts to increase understanding about this condition.'
ALGSA (www.alagille.org) is an international advocacy group representing patients and families. The nonprofit facilitates in-person and digital forums to increase community education and awareness among families, healthcare providers, and scientists. ALGSA also provides assistance programs to families in need and sponsors grants to advance scientific research.
'We celebrate the Alagille community's successes in raising awareness. Each win is a step in the right direction towards what, hopefully, will be a better quality of life for everyone affected by rare cholestatic liver diseases,' said Ron Cooper, President and Chief Executive Officer of Albireo. 'Since our inception in 2008, Albireo has been relentlessly focused on developing treatments for serious cholestatic liver diseases.'
Albireo is committed to improving treatment options and outcomes for people with rare cholestatic liver diseases. Albireo initiated the first pivotal trial in the cholestatic liver disease progressive familial intrahepatic cholestasis, and plans to advance development of its investigational product, odevixibat, in other rare cholestatic liver diseases, which could include Alagille syndrome.
Albireo Pharma is a clinical-stage biopharmaceutical company focused on the development of novel bile acid modulators to treat orphan pediatric liver diseases, and other liver and gastrointestinal diseases and disorders. Albireo's lead product candidate, odevixibat, is being developed to treat rare pediatric cholestatic liver diseases and is in Phase 3 development in its initial target indication, progressive familial intrahepatic cholestasis. Albireo's clinical pipeline also includes two Phase 2 product candidates. Albireo's elobixibat, approved in Japan for the treatment of chronic constipation, is the first ileal bile acid transporter (IBAT) inhibitor approved anywhere in the world.
Albireo was spun out from AstraZeneca in 2008. Albireo Pharma is based in Boston, Mass., and its key operating subsidiary is in Gothenburg, Sweden. The Boston Business Journal named Albireo one of the 2019 Best Places to Work in Massachusetts. For more information on Albireo, please visit www.albireopharma.com.
This press release includes 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements, other than statements of historical fact, regarding, among other things: the plans for, or progress, scope, cost, duration or results or timing for availability of results of, development of odevixibat, including regarding the Phase 3 clinical program for odevixibat in patients with PFIC; the target indication(s) for development, the size, design, population, location, conduct, objective, enrollment, duration or endpoints of any clinical trial, or the timing for initiation or completion of or reporting of results from any clinical trial, including the double-blind Phase 3 PFIC trial for odevixibat; the potential approval and commercialization of odevixibat; the potential benefits or competitive position of odevixibat or the commercial opportunity in any target indication. Albireo often uses words such as 'anticipates,' 'believes,' 'plans,' 'expects,' 'projects,' 'future,' 'intends,' 'may,' 'will,' 'should,' 'could,' 'estimates,' 'predicts,' 'potential,' 'planned,' 'continue,' 'guidance,' and similar expressions to identify forward-looking statements. Actual results, performance or experience may differ materially from those expressed or implied by any forward-looking statement as a result of various risks, uncertainties and other factors, including, but not limited to: whether favorable findings from clinical trials of odevixibat to date, including findings in indications other than PFIC, will be predictive of results from the trials comprising the Phase 3 PFIC program or any other clinical trials of odevixibat; whether either or both of the FDA and EMA will determine that the primary endpoint for their respective evaluations and treatment duration of the double-blind Phase 3 trial in patients with PFIC are sufficient, even if the primary endpoint is met with statistical significance, to support approval of odevixibat in the United States or the European Union, to treat PFIC, a symptom of PFIC, a specific PFIC subtype(s) or otherwise; the outcome and interpretation by regulatory authorities of the ongoing third-party study pooling and analyzing of long-term PFIC patient data; the timing for initiation or completion of, or for availability of data from, clinical trials of odevixibat, including the trials comprising the Phase 3 PFIC program, and the outcomes of such trials; Albireo's ability to obtain coverage, pricing or reimbursement for approved products in the United States or European Union; delays or other challenges in the recruitment of patients for, or the conduct of, the double-blind Phase 3 trial; and Albireo's critical accounting policies. These and other risks and uncertainties that Albireo faces are described in greater detail under the heading 'Risk Factors' in Albireo's most recent Annual Report on Form 10-K or in subsequent filings that it makes with the Securities and Exchange Commission. As a result of risks and uncertainties that Albireo faces, the results or events indicated by any forward-looking statement may not occur. Albireo cautions you not to place undue reliance on any forward-looking statement. In addition, any forward-looking statement in this press release represents Albireo's views only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. Albireo disclaims any obligation to update any forward-looking statement, except as required by applicable law.
Bill Berry, Berry & Company Public Relations, (212) 253-8881, [email protected]
Source: Albireo Pharma, Inc.
Source: Albireo Pharma, Inc.