Programmes
Clinical Programme
The lead compound, A3309, is in clinical development in patients with chronic constipation. Constipation is one of the most common gastrointestinal (GI) complaints. Chronic constipation is a more severe and disabling disease, which is not effectively managed by over the counter (OTC) laxatives. In the US, it is one of the most common self-reported GI disorders; its prevalence increasing with age up to 25% in adults over the age of 65. More than 4 million Americans have frequent constipation resulting in 9 million physician visits annually and in addition leads to more than 92,000 hospitalisations annually in the US. In a survey study of 557 individuals with chronic constipation, 47% of respondents indicated a lack of satisfaction with treatment (82% citing lack of treatment efficacy as the reason for dissatisfaction).
Given the mode of action, A3309 should also be beneficial for patients with constipation-predominant Irritable Bowel Syndrome (IBS-C). 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.
A3309 is an orally available therapeutic alternative with a novel mechanism of action. A3309 modulates the enterohepatic circulation of bile acids by inhibiting the Ileal Bile Acid Transporter (IBAT), also called Apical Sodium Dependent Bile Acid Transporter (ASBT). This will result 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 IBS-C and CIC.
Albireo is currently performing studies in patients with CIC to identify an appropriate dose level for moving forward into Phase III and in order to evaluate gastrointestinal transit changes. Plans are for further evaluation in patients with IBS-C. Given the mechanism of action, patients with dyslipidemia may benefit from treatment with A3309 and such a study is also ongoing. Further information on these studies are available at http://www.clinicaltrial.gov/ct2/results?term=A3309
Preclinical Programme
Albireo has two preclinical programmes, primarily aimed for the treatment of Inflammatory Bowel Disease (IBD) such as ulcerative colitis and Crohn´s disease affecting about 1% of the population. The disease appears often at young age, causing great suffering. The recent development of new drugs for IBD has mainly been biological products. Because present therapies for IBD have either sub-optimal efficacy or safety and/or tolerability issues, there is still a great unmet medical need in this disease area and the major part of the patient population would benefit from a treatment option using low molecular drugs for oral administration.
The first programme is aimed to develop a neurokinin(NK) receptor antagonist as a first-in-class treatment of IBD and/or IBS. The antagonists are potent on both NK1 and NK2 receptors and are efficacious in animal models of both IBD and IBS. The program is in late preclinical development phase.
The second program is aimed to develop a locally active PPAR agonist as a first-in-class treatment of IBD. The mechanism of action is clinically proven. The compounds exhibit gastrointestinal anti-inflammatory effect avoiding systemic exposure. The program is in preclinical phase