ALBO Albireo Pharma Inc

Albireo Pharma, Inc. (Nasdaq: ALBO), a rare disease company developing novel bile acid modulators to treat pediatric and adult liver diseases, today announced the winners of the Supporting PFIC Advances Research and Knowledge (SPARK) grants program, established by Albireo to identify and drive forward improvements in the quality of care for rare liver diseases, beginning with progressive familial intrahepatic cholestasis (PFIC). Each of these winning projects was selected due to the tangible and significant contribution it will make to the PFIC patient community, and towards improving the lives of patients and their families.

“We are very excited by the success we’ve had in the inaugural year of our SPARK grants program, and by all the remarkable projects that were submitted and accepted. It is this type of study, focus and innovation that will bring relief to the PFIC and larger liver disease community,” said Ron Cooper, President and Chief Executive Officer of Albireo. “As a company, our mission is to provide hope for patients and their families. The SPARK program, and continuing to fund research, is one of the ways we are making an impact.”

Albireo received a significant number of submissions that addressed the criteria of sustainable, innovative, replicable projects which improve the standard of care of PFIC and optimize the care pathway.

Judging was conducted by a panel of multinational clinical experts in PFIC and rare liver disease as well as Albireo senior management:

• Rainer Ganschow, MD, PhD, Director of General Pediatrics, Center for Pediatrics, University Hospital Bonn, Germany
• Tassos Grammatikopoulos, MD(Res), FRCPCH, Consultant in Pediatric Hepatology, King's College Hospital NHS Foundation Trust, UK
• Giuseppe Maggiore, MD, Managing Director, Division of Hepatogastroenterology and Nutrition, Ospedale Pediatrico Bambino Gesù, Italy
• Karen Murray, MD, Chair, Pediatric Institute, Physician-in-Chief and President, Cleveland Clinic Children’s Hospital for Rehabilitation, US
• Emily Ventura, Chief Executive Director, PFIC Network.

“It was such an honor to take part in the judging for the SPARK grants program,” said Emily Ventura, Executive Director, PFIC Network. “The caliber and quantity of project submissions were impressive and led to a difficult judging process. I am very excited to see the selected programs come to fruition and believe each project will significantly contribute to the PFIC community.”

See below for the full list of winners, as well as the accepted projects:

SPARK 2022 Winners

Dr. Angelo di Giorgio, Hospital Papa Giovanni XXIII, Bergamo, Italy; Prognostic value of sBA levels on disease progression of pediatric patients with PFIC

Dr. Toni Illhardt, University Children's Hospital Tuebingen, Germany; Actigraphy- a tool to assess the degree of pruritus in pediatric cholestatic liver diseases

Dr. Nolwenn Laborde, Toulouse University Hospital, France; Bright smile for Bright life

Prof. Raffaele Lorio, University of Naples “Frederico II”, Italy; ICP: bringing out the submerged

Andrea Pietrobattista, MD, Bambino Gesù Children Hospital, Rome, Italy; Improving care of PFIC patients in clinical practice: focus on sleep disorders and their negative outcome on patients and caregiver quality of life

Giovanni Vitale, MD, University Hospital Bologna, Italy; Optimizing the diagnostic workflow in adult patients with cryptogenic cholestatic liver diseases through a genotype-phenotype screening approach using the Next Generation Sequencing analysis.

Mrs. José Willemse, MSc, Dutch Liver Patients Association, Netherlands; It's going well, right? The hidden burden of parents with a child with liver disease

Prof. Filomena Morisco, University of Naples “Frederico II”, Italy; Intrahepatic cholestasis of pregnancy: a first manifestation of unknown PFIC

Albireo will continue its efforts to drive innovation and best-practice application in patient care with the SPARK program next year, with grant details to come at the European Association for the Study of the Liver’s (EASL) 2023 congress. In the meantime, more information can be found at spark-grants.com.

About Albireo 

Albireo Pharma is a rare disease company focused on the development of novel bile acid modulators to treat pediatric and adult liver diseases. Albireo’s lead product, Bylvay, was approved by the U.S. FDA as the first drug for the treatment of pruritus in all types of progressive familial intrahepatic cholestasis (PFIC), and it is also being developed to treat other rare pediatric cholestatic liver diseases with a completed Phase 3 trial in Alagille syndrome (ALGS), an ongoing Phase 3 study in biliary atresia, as well as Open-label Extension (OLE) studies for PFIC and ALGS. In Europe, Bylvay is reimbursed for the treatment of PFIC in Germany, England, Wales & Northern Ireland, Scotland, Italy, and Belgium. The Company has also completed a Phase 1 clinical trial for A3907 to advance development in adult cholestatic liver disease, with IND-enabling studies progressing with A2342 for viral and cholestatic liver disease. Albireo was spun out from AstraZeneca in 2008 and is headquartered in Boston, Massachusetts, with its key operating subsidiary in Gothenburg, Sweden. For more information on Albireo, please visit www.albireopharma.com. 

Forward-Looking Statements

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 SPARK grant program, including the impact of the program and its selected projects; Albireo’s commercialization plans; the plans for, or progress, scope, cost, initiation, duration, enrollment, results or timing for availability of results of, development of Bylvay, A3907, A2342 or any other Albireo product candidate or program; or Albireo’s plans, expectations or future operations, financial position, revenues, costs or expenses. Albireo often uses words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “planned,” “continue,” “guidance,” or the negative of these terms or other 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 the SPARK program and its selected projects will improve standard of care; whether the regulatory filings to be made for Bylvay in patients with ALGS will be made on the timelines we expect and be approved by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA); whether the FDA and EMA will complete their respective reviews within target timelines, once determined; whether the FDA and EMA will require additional information, whether we will be able to provide in a timely manner any additional information that the FDA and EMA request, and whether such additional information will be satisfactory to the FDA and EMA; there are no guarantees that Bylvay will be commercially successful; we may encounter issues, delays or other challenges in commercializing Bylvay; whether Bylvay receives adequate reimbursement from third-party payors; the degree to which Bylvay receives acceptance from patients and physicians for its approved indication; challenges associated with execution of our sales activities, which in each case could limit the potential of our product; challenges associated with supply and distribution activities, which in each case could limit our sales and the availability of our product; results achieved in Bylvay in the treatment of patients with PFIC or other approved indications may be different than observed in clinical trials, and may vary among patients; potential negative impacts of the COVID-19 pandemic, including on manufacturing, supply, conduct or initiation of clinical trials, or other aspects of our business; whether favorable findings from clinical trials of Bylvay to date, including findings in PFIC, ALGS and other indications, will be predictive of results from other clinical trials of Bylvay; there is no guarantee that Bylvay will be approved in jurisdictions or for indications (such as biliary atresia or ALGS) beyond the jurisdictions in which or indications for which Bylvay is currently approved; there is no guarantee that our other product candidates will be approved; estimates of the addressable patient population for target indications may prove to be incorrect; 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 Bylvay, including BOLD, and the Phase 2 clinical trial of A3907, and the outcomes of such trials; Albireo’s ability to obtain coverage, pricing or reimbursement for approved products in the United States or Europe; delays or other challenges in the recruitment of patients for, or the conduct of, the Company’s clinical trials; any repurchase by the Company of Sagard’s interest in the royalty interest payments under our royalty monetization agreement with Sagard could materially impact our financial condition; and the Company’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. 

Media Contacts:Colleen Alabiso, 857-356-3905, colleen.alabiso@albireopharma.comLance Buckley, 917-439-2241, lbuckley@lippetaylor.com

Investor Contact:Hans Vitzthum, LifeSci Advisors, LLC., 617-430-7578