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Albireo Announces Positive Results From a Study With A3309 in Patients With Chronic Constipation
Date:4/29/2010

GOTHENBURG, Sweden, April 29, 2010 /PRNewswire/ -- Albireo today announced that additional clinical data will be reported from a recent study assessing the safety, tolerability and efficacy of A3309 in patients with chronic constipation. A3309 is a first-in-class investigational compound for the treatment of irritable bowel syndrome with constipation (IBS-C) and chronic constipation (CC). The results will be presented during the 2010 Digestive Disease Week (DDW) annual meeting being held in New Orleans, US.

The presentation was selected as a "poster of distinction", meaning that the poster was in the top 10% of all AGA Institute abstracts selected for poster presentation. In addition, a poster presenting the preclinical A3309 data has been accepted.

    Details of the DDW session:

    Session Type: Poster Session
    Session Title: Constipation and IBS: Diagnosis and Treatment
    Session Date & Time: May 2, 2010 from 8:00 a.m. to 5:00 p.m.

    Title of the clinical abstract:
    The IBAT inhibitor A3309 - A Promising Treatment option for Patients with
    Chronic Idiopathic Constipation

    Title of the abstract describing preclinical findings:
    The IBAT inhibition by A3309 - A potential mechanism for the treatment of
    constipation

"The results show that A3309 was found to be safe and well tolerated and identified clear signs of improving colonic motility and bowel habits," said Magnus Simren, Principal Investigator (Institute of Medicine, Sahlgrenska Academy, University of Gothenburg , Sweden). "We are excited about the results of the trial, which confirms the potential that A3309 will benefit all those patients suffering from constipation and abdominal pain/discomfort who are refractory to OTC drugs," said Hans Graffner, Chief Medical Officer at Albireo. "The Albireo team looks forward to advancing the development of A3309, a first-in-class compound with a novel mode of action, and to create a new tool in the therapeutic armamentarium for these patients with limited treatment options."

A3309 is currently being evaluated in a large Phase IIb study in chronic constipation enrolling approximately 180 patients in the US and further investigation of A3309's enhancement of large bowel transit is being conducted at the Mayo Clinic. Also, given the mode of action, A3309 may be beneficial in patients with dyslipidemia and a study to evaluate A3309 in patients with high cholesterol levels is conducted in Sweden. Results of these clinical studies will be available late this year and plans are to move forward into Phase III in chronic constipation during 2011.

About the Results Presented at DDW

In the randomized, double-blind, placebo-controlled, prospective dose-escalating study, 30 patients were administered placebo or A3309 in a dose range of 0.1 mg - 10 mg for 14 days. In addition to evaluating safety and tolerability, bowel habits and gastrointestinal symptoms from patient diaries and radiographic assessments of transit were used to assess the efficacy of A3309.

There were no serious adverse events reported and no patient discontinued the trial. Adverse events were evenly distributed across the different dose levels and no difference was observed compared to placebo.

The mode of action - inhibition of bile acid re-absorption in the small bowel - was clearly demonstrated by biomarker analysis and colonic transit was improved in the higher dose groups as was the number of bowel movements. In addition, stool consistency improved.

In the poster describing the preclinical experiments, A3309 is identified as a highly potent and selective compound for the ileal bile acid transporter (IBAT or ASBT), ameliorating meal-induced constipation in dogs.

About A3309

A3309 is a therapeutic alternative with a novel mechanism of action developed for the treatment of chronic idiopathic constipation and Irritable Bowel Syndrome with constipation (IBS-C). A3309 modulates the re-uptake of bile acids by inhibiting the ileal bile acid transporter (IBAT or ASBT). This results in an increased concentration of bile acids in the colon which, in turn, increase fluid secretion and colonic motility. These physiological responses should provide benefits to patients with chronic constipation and IBS-C without any effects on other parts of the gastrointestinal tract.

About Chronic Constipation (CC) and IBS-C Irritable Bowel Syndrome with constipation (IBS-C)

Chronic constipation is among the most common diseases, affecting approximately 15 % of the general population in particular women and the elderly population. CC adversely affects a person's quality of life and is associated with significant health care expenditure. Studies show that approximately 50 % of individuals with CC are not satisfied with available treatments underscoring the unmet medical need in this area.

IBS-C is a disease characterized by a combination of abdominal pain and constipation. Throughout the world, about 10%-20% of adults have symptoms consistent with IBS, and most studies find a female predominance. IBS symptoms come and go over time, often overlap with other functional disorders, impair quality of life, and result in high health care costs. There is a high rate of dissatisfaction with available therapies.

About DDW

DDW is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. The conference is jointly sponsored by four medical societies: the American Association for the Study of Liver Diseases, the American Gastroenterological Association, the American Society for Gastrointestinal Endoscopy and the Society for Surgery of the Alimentary Tract. More information on the annual meeting is available at http://www.ddw.org.

About Albireo

Albireo is an independent Swedish biotechnology company, which brings unique translational approaches to develop drugs that fulfill unmet medical needs in the gastrointestinal (GI) area. The Albireo team has a broad experience in drug development, primarily in the GI area and has an extensive network in the international scientific and clinical communities. Albireo was created as a spin out of AstraZeneca and was based on a platform of clinical and preclinical GI programs emanating from within AstraZeneca. Albireo has raised $40m in a Series A financing round from leading healthcare investors including Nomura Phase4 ventures, TPG Biotech, TVM Capital and Scottish Widows Partnership.

To learn more about Albireo, visit http://www.albireopharma.com. The posters will be available on the web site on May 3.


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