Albireo Announces Positive Results From a Study With A3309 in Patients With Chronic Constipation
At Digestive Disease Week 2010, Data Will be Presented Demonstrating That A3309 is Well Tolerated and Improves Both Colonic Motility and Bowel Habits in Chronic Constipation
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.
Source: Albireo AB
Albireo: Jan P. Mattsson (COO), +46(0)768-08-35-04,
info@albireopharma.com
Posted: April 2010
