New Data Presented at UEGW Confirm Effectiveness and Safety of RESOLOR(R) for Patients With Chronic Constipation
Paris (ots/PRNewswire)
- Novel Compound Offers Hope to Patients not Adequately Responding to Laxative Treatment
Data presented for the first time today at the international gastroenterology meeting UEGW (United European Gastroenterology Week) confirm the effectiveness and safety of RESOLOR(R) (prucalopride), a novel and selective, high-affinity 5-HT(4) receptor agonist, for patients suffering from Chronic Constipation (CC) for whom laxatives do not provide adequate relief(1).
Findings from this randomised, double-blind, placebo-controlled trial evaluating the effectiveness and safety of RESOLOR (2 mg and 4 mg) in patients with CC over 4 and 12 weeks demonstrated similar results for both doses, which were significantly different from placebo (p is less than or equal to 0.01) at the primary endpoint, where the proportion of patients treated with RESOLOR having an average of greater than or equal to 3 spontaneous complete bowel movements (SCBM) more than doubled, over 4 and 12 weeks, versus the placebo group. RESOLOR also reduced perceived severity of symptoms, improved disease-related quality of life (QOL), and was safe and well tolerated.
Lead investigator Jan Tack, Professor and Head of Clinic, Division of Gastroenterology, University Hospital Gasthuisberg, University of Leuven, Belgium, commented "If not treated appropriately, CC can have a significant impact on patients' well-being. The debilitating effects on work, mental health and relationships are often underestimated. Achieving three or more spontaneous complete bowel movements per week for a patient with CC can be considered a return to a normal bowel frequency. The data therefore confirm that treatment with RESOLOR, for this difficult to treat patient population, resulted in normalisation in approximately 25% of patients and a clinically meaningful improvement in an additional 20%. This is a clear step forward in treating a population in need of effective treatments."
Dirk Reyn, CEO of Movetis, added "At Movetis we are committed to discover and develop products targeting gastrointestinal conditions previously neglected by innovation. These convincing Phase III data demonstrate that RESOLOR can really make a difference for the millions of patients who have tried laxatives without success. We are planning to file RESOLOR for European marketing approval in mid-2008."
About the trial
This Phase III trial, the first of three identical, multicentre, parallel-group, randomised, double-blind, placebo-controlled trials, evaluated 713 patients (90.8% female, mean age approximately 43 years), with long-standing (at least 18 years of disease history on average) and more severe CC (less than 2 SCBM/week) with straining or sensation of incomplete evacuation or with hard stools. The primary objective was to assess the proportion of patients reporting on average three or more SCBM/week during 4 weeks and the 12-week treatment period - a very stringent primary endpoint, as agreed with the European Health Authorities. At inclusion, patients had less than 2 SCBM per week and more than 80% declared that previous treatment with laxatives did not provide adequate relief. Patients received oral doses of 2 mg or 4 mg RESOLOR, once daily, for 12 weeks. Percentages of patients with greater than or equal to 3 SCBM/week averaged over 4 and 12 weeks were:
- 10.4% and 9.6% for placebo
- 23.7% and 19.5% for 2 mg RESOLOR
- 26.6% and 23.6% for 4 mg RESOLOR.The following secondary objectives were significantly improved with 2 mg RESOLOR versus placebo (averaged over the 4- and 12-week treatment periods):
- percentage of patients with an increase of one or more SCBM/week (41.0%
vs. 20.9% and 38.1 vs. 20.9%, respectively; p is less than or equal to
0.01)
- percentage of bowel movements with normal consistency (p is less than
or equal to 0.05)
- percentage of BM with no straining (p is less than or equal to 0.01)
- perceived severity of constipation (p is less than or equal to 0.001)
- overall PAC-SYM scores (p is less than or equal to 0.001).
- overall treatment satisfaction scores (p is less than or equal to 0.001)Similar findings (all statistically significant) were observed with 4 mg RESOLOR.
RESOLOR was reported safe and well tolerated, and no drug-related serious cardiac events were reported.
About RESOLOR
RESOLOR is a novel enterokinetic treatment for CC in a patient population not adequately relieved by laxative treatments. It is a selective, high-affinity 5-HT(4) receptor agonist, which increases colon motility and restores the slow movement of the bowels in a dose-dependent manner. RESOLOR has now completed three Phase III studies and been tested in more than 3,000 patients. Movetis is planning to file for European marketing approval in mid-2008.
About Chronic Constipation (CC)
CC is a disorder of the gastro-intestinal (GI) tract. It is a prevalent and debilitating condition that is not always well understood and is in many cases inadequately treated. Different guidelines define CC as less than 3 bowel movements per week for at least 6 months. This is usually accompanied by pain and or excessive straining during the passage of a bowel movement. Patients often complain that stools are either too hard, too infrequent, too difficult to pass or incomplete and therefore unsatisfactory(2). In Europe, an estimated 8.5 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). However, the true prevalence of CC is often underestimated since not all patients seek medical advice.
About Movetis
Through a clear focus on GI, Movetis seeks to improve the lives of millions of patients - both adults and children - by discovering, developing and commercialising innovative treatments targeting GI conditions previously neglected by innovation. Movetis NV - founded in Belgium in December 2006 - aims to become the leading European specialty pharmaceutical organisation focused on GI diseases. Movetis has a broad GI portfolio with four products in clinical development and four in preclinical, all addressing important areas of unmet medical need, including CC, ascites, paediatric reflux, diabetic gastroparesis, severe forms of dyspepsia and secretory diarrhoea. In addition, Movetis owns a large library of qualified lead compounds with potential for development. The current portfolio has been licensed from Janssen Pharmaceutica NV, Belgium and Ortho-McNeil Pharmaceutical Inc., two Johnson & Johnson (J&J) companies.
The current clinical portfolio includes:
- RESOLOR (prucalopride), a compound for the treatment of CC currently in
preregistration
- M0002, a compound for the treatment of ascites, currently in Phase II
- M0003, a gastrokinetic compound for the treatment of paediatric reflux
and gastroparesis, which will enter Phase IIa clinical trials in Q1 2008
- M0004, another gastrokinetic compound for motility complaints related
to gastro-oesophageal reflux disease (GORD).In 2006, Movetis secured 49 million Euros in a series 'A' financing from major European and US investors - one of the biggest series 'A' rounds in Europe. These funds are being used to complete the development and registration filing of RESOLOR, and to continue preclinical and clinical development of all other products. Investors include Sofinnova Partners, J&J, Life Sciences Partners, Sofinnova Ventures, KBC Private Equity and KBC Private Equity Fund Biotech, GIMV, Quest for Growth and BIP Investment Partners. Movetis is based in Turnhout, Belgium.
References
(1) J. Tack, G. Tan, L. Vandeplassche. A randomized, double-blind, placebo-controlled trial to evaluate efficacy and safety of prucalopride in patients with chronic constipation. Abstract OP-G-377, UEGW 2007.
(2) P. Pare, S. Ferrazzi, W.G. Thompson, et al. An epidemiological survey of constipation in Canada: definitions, rates, demographics, and predictors of health care seeking. Am J Gastroenterol 2001;96:3130-7.
(3) IMS Health.
(4) Higgins PD, Johanson JF. Epidemiology of constipation in North America: a systematic review. Am J Gastroenterol 2004;99:750-9.
Visit http://www.movetis.com/news.aspx to download the press release (Tuesday 30 October 2007, from 14.00 CET)
Contact:
For further information contact Axon Communications: Ludivine
Delattre, Tel: +44-(0)20-8439-9477, ldelattre@axon-com.com; Sarah
Griffin, Tel: +44-(0)20-8439-9582, sgriffin@axon-com.com