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New Published Data Support Safety and Efficacy of RESOLOR(R) for Treatment of Chronic Constipation

Turnhout, Belgium (ots/PRNewswire)

- New Generation Compound Provides Significant Benefit in
Patients who  do not Adequately Respond to Laxatives
New phase III data for RESOLOR(R) (prucalopride) published today
in The New England Journal of Medicine (NEJM) shows statistically and
clinically significant improvement of bowel function and reduced
severity of symptoms in patients with chronic constipation(1).
Prucalopride is the most advanced in a new generation of selective,
high-affinity 5-HT4 receptor agonists, specifically designed to help
patients for whom laxatives do not provide adequate relief.
In this randomized, placebo-controlled trial of 620 patients with
severe chronic constipation, the proportion of patients achieving the
primary study endpoint of average greater than or equal to 3
spontaneous complete bowel movements per week (SCBM/week) was
significantly higher in both Prucalopride groups (2mg and 4mg)
compared with placebo over both 4 and 12 weeks of treatment.
Additionally, Prucalopride significantly improved the secondary
efficacy endpoints, including satisfaction with bowel function and
treatment, abdominal and stool symptoms, perception of constipation
severity, and disease-related quality of life.
Jan Tack, Professor and Head of Clinic, Division of
Gastroenterology, University Hospital Gasthuisberg, University of
Leuven, Belgium, commented, "These are valuable and relevant findings
because the demanding endpoint in this study combines both a
subjective measure of the completeness of evacuation with an
objective measure of the number of bowel movements, reflecting relief
of chronic constipation and normalization of bowel function. The high
selectivity of Prucalopride towards the 5-HT4 receptor offers the
benefit that patients are unlikely to suffer from the side effects
associated with the older generation, nonselective compounds. This
meets the needs of doctors and patients by offering an effective
treatment with an improved side effect profile."
Dirk Reyn, CEO of Movetis, added, "We are pleased with the
publication of this data in NEJM because it gives credibility and
support to the strength of our phase III dataset. It also reflects
the need for a safe, efficacious treatment of chronic constipation
which is currently unmet. For years, the impact of chronic
constipation has been underestimated and research relating to this
condition has been much less than in other medical fields. In Europe
alone, approximately 10 million patients visit their doctors seeking
help after unsatisfactory results with over-the-counter medications.
We hope that RESOLOR(R) will help to improve the lives of these
patients both in Europe and worldwide."
About the trial
The phase III trial, the second of three identical, multi-centre,
parallel-group, randomized, double-blind, placebo-controlled trials,
evaluated 620 adult patients with a history of chronic constipation
(defined as less than or equal to 2 SCBM/ week for a minimum of 6
months prior to the selection visit). In addition, patients had to
experience very hard or hard stools, a sensation of incomplete
evacuation, or straining during defecation with at least 25% of their
bowel movements. The primary objective was to assess the proportion
of patients reporting on average three or more SCBM/week during a 12
week treatment period - a very demanding primary endpoint.
Patients received oral doses of 2mg or 4mg Prucalopride, once
daily, for 12 weeks. Percentages of patients with greater than or
equal to 3 SCBM/week averaged over 12 weeks respectively were:
  • 12.0% for placebo
  • 30.9% for 2mg Prucalopride
  • 28.4% for 4mg Prucalopride.
The following secondary endpoints were significantly improved
with 2mg and 4mg Prucalopride over 12 weeks:
  • Percent of patients with an average increase of greater than or equal to 1 SCBM/week (p<0.001)
  • Average number of spontaneous complete bowel movements per week (p<0.001)
  • Percentage of bowel movements with normal consistency (p<0.001)
  • Patients rating treatment effective or extremely effective (p<0.001)
  • Stool and abdominal symptom scores (p<0.001)
  • Percent of patients with an improvement of greater than or equal to 1 point on a disease specific and validated Quality of Life scale (PAC-QOL) (p<0.001)
Prucalopride (2mg and 4mg) also significantly reduced time to
first spontaneous complete bowel movements and reduced laxative use
during treatment compared to placebo (both p<0.001)
Prucalopride was well tolerated in this study population. The
most frequent Adverse Events were headache, nausea and diarrhea.
There were no significant cardiovascular effects of treatment. There
were no differences between treatment groups in lab values, vital
signs or ECG parameters.
About RESOLOR(R)
RESOLOR (prucalopride ) is a novel enterokinetic treatment for
chronic constipation in a patient population not adequately relieved
by laxative treatments. It is a selective, high-affinity 5-HT4
receptor agonist, which increases colon motility and restores the
slow movement of the bowels in a dose-dependent manner. RESOLOR has
completed three Phase III studies and has been tested in more than
3,000 patients. Movetis filed for European marketing approval in
April 2008.
About chronic constipation
Chronic constipation is a disorder of the gastrointestinal tract.
It is a prevalent and debilitating condition that is not always well
understood and in many cases inadequately treated. The ROME III
guidelines define chronic constipation as two or more of the
following symptoms at least a quarter of the time for at least six
months: straining, lumpy or hard stools, a sensation of incomplete
evacuation, a sensation of anorectal obstruction or blockage, and/or
less than 3 defecations per week(2) . In Europe, an estimated 10
million patients frequently visit their doctors with complaints of
constipation after dissatisfactory results with over-the-counter
medication(3). Constipation is more common in women than men
(estimated prevalence ratio of 2.2:1)(4).
About Movetis
Through a clear focus on gastroenterology, Movetis seeks to
improve the lives of millions of patients - both adults and children
- by discovering, developing and ultimately commercializing
innovative treatments targeting GI conditions with a high unmet
medical need. Movetis NV - founded in Belgium in December 2006 - aims
to become a leading European specialty pharmaceutical organization
focused on GI diseases. Movetis has a broad GI portfolio with four
products in clinical development and four in preclinical, all
addressing important GI areas with fewer innovative products,
including chronic constipation, ascites, paediatric reflux in
infants, diabetic gastroparesis and non erosive reflux disease. In
addition, Movetis owns a large library of qualified lead compounds
with potential for development in disease areas such as secretory
diarrhea. The current portfolio has been licensed from Janssen
Pharmaceutica NV, Belgium and Ortho-McNeil Pharmaceutical Inc., two
Johnson & Johnson (J&J) companies.
The current portfolio includes:
  • RESOLOR (prucalopride), a compound for the treatment of chronic constipation currently filed for review for Marketing Authorisation in Europe
  • M0002, a selective V2 receptor antagonist compound for the treatment of ascites that has concluded recruitment of a Phase IIa trial. Results are expected before the end of Q2 2008.
  • M0003, a gastrokinetic compound for the treatment of paediatric reflux in infants and symptoms of gastroparesis, which has entered a Phase IIa clinical trial in Q1 2008.
  • M0004, another gastrokinetic compound for motility complaints related to non erosive or refractory gastro-oesophageal reflux disease (GORD) ready to move into clinical development.
References
1. Camilleri M, Kerstens R, Rykx A, Vandeplassche L. A
Placebo-Controlled Trial of Prucalopride for Severe Chronic
Constipation. NEJM 2008 In Press
2. A Drossman (2006) Rome III: The new criteria. Chinese Journal
of Digestive Diseases 7 (4) , 181-185.
3. IMS Health.
4. Higgins PD, Johanson JF. Epidemiology of constipation in North
America: a systematic review. Am J Gastroenterol 2004;99:750-9.

Contact:

Vicki Martin, Tel: +44(0)20-8439-9407, vmartin@axon-com.com; Sarah
Griffin, Tel: +44(0)20-8439-9582, sgriffin@axon-com.com

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