GOTHENBURG, Sweden, November 18 Albireo today announcedthe completion of a phase 1b study showing a favorable tolerability andsafety profile of A3309 in patients with chronic idiopathic constipation. Inaddition, the data revealed appropriate efficacy signals in this patientpopulation. A3309 is a first in class compound developed for the treatment ofchronic idiopathic constipation and constipation-predominant Irritable BowelSyndrome (IBS-C). Based on these results, Albireo expects to recruit 180patients with chronic idiopathic constipation in a US phase 2b study(http://www.clinicaltrials.gov) under an IND recently placed into effect bythe FDA.
Notes for Editors:
Constipation is one of the most common gastrointestinal complaints.Chronic idiopathic constipation is a more severe and disabling disease, whichis not effectively managed by current treatment options. More than 4 millionAmericans have chronic constipation resulting in 9 million physician visitsannually and in addition lead to more than 92,000 hospitalizations annually.In a survey study of 557 individuals with chronic constipation, 47% ofrespondents indicated a lack of satisfaction with treatment (82% citing lackof treatment efficacy as the reason for dissatisfaction).
A3309 is a therapeutic alternative with a novel mechanism of actiondeveloped for the treatment of chronic idiopathic constipation andconstipation-predominant Irritable Bowel Syndrome (IBS-C). A3309 modulatesthe re-uptake of bile acids by inhibiting the ileal bile acid transporter.This will result in an increased concentration of bile acids in the colonwhich, in turn, increase fluid secretion and colonic motility. Thesephysiological responses should provide benefits to patients with chronicconstipation and IBS-C without any effects on other parts of thegastrointestinal tract.
Albireo is an independent Swedish biotechnology company focused on thedevelopment of novel therapeutic alternatives to fulfill medical needs in thegastrointestinal area. Albireo was spun-out of AstraZeneca in February 2008and is financed by a syndicate of growth capital firms, including NomuraPhase4 Ventures, TPG growth, TVM Capital and Scottish Widows InvestmentPartnership. The company has raised $40m in its Series A financing round(http://www.albireopharma.com).