VIENNA, Austria, October 22 /PRNewswire/ -- New data presented at the United European Gastroenterology Week (UEGW) confirm the efficacy and safety of prucalopride, a novel enterokinetic compound, in patients with chronic constipation for whom laxatives do not provide adequate relief.
Prucalopride was evaluated in a large double-blind (n=231), placebo-controlled, phase II dose-finding trial (USA-3) that supports the choice of 2 mg as the lowest effective dose. Both the 2 mg and 4 mg dosing of prucalopride were superior to the 0.5 mg and 1 mg dosing with 4 mg showing a marginal benefit over 2 mg but a less favourable AE profile. There was no rebound effect during the run-out phase. Prucalopride was well tolerated at all doses tested.
In a phase III trial (USA-28) aimed at studying the effects of retreatment with prucalopride, the product demonstrated rapid and sustained symptom relief in patients with chronic constipation. The efficacy findings during 4 weeks of treatment were comparable to those during 4 weeks of re-treatment. It was also shown that episodic use of 4 mg prucalopride was well tolerated.
From a safety perspective, prucalopride is well tolerated at repeated doses up to 5 times the anticipated therapeutic dose for treatment of chronic constipation. In a randomized, double-blind, placebo-controlled, cross-over trial (GBR-9) focusing on cardiovascular safety of prucalopride in healthy subjects, no significant difference versus placebo was noted on a variety of CV parameters including BP, QT and HR.
Furthermore, at UEGW, data from a small double-blind, placebo-controlled, cross-over trial (GBR-7) to evaluate the effects of prucalopride in patients with chronic intestinal pseudo-obstruction (CIP) due to visceral myopathy or neuropathy, were presented that demonstrated the favourable effect prucalopride had a on pain, nausea, vomiting, bloating and analgesic intake.
The pharmacokinetic (PK) profile of prucalopride was documented in a trial involving male and female subjects. The product has a predictable PK profile and can be taken with or without meals. Its half-life allows for once daily (o.d.) dosing. Prucalopride has a low potential for metabolic drug-drug interactions, including CYP 450 iso-systems. This further confirms the wide safety margin of the product.
. Dirk Reyn, CEO of Movetis, commented: We are pleased with the presentation of these data at UEGW because it reinforces the strength of our dataset after recent publications in peer reviewed journals like the New England Journal of Medicine (NEJM). Lieve Vandeplassche, VP late clinical development for Resolor at Movetis continues: There is a serious unmet need for a well tolerated, efficacious treatment for chronic constipation. For years, the impact of chronic constipation has been underestimated and research relating to this condition has been much less than in other medical areas. In Europe alone, approximately 10 million patients visit their doctors seeking help after unsatisfactory results with over-the-counter medications. We hope that prucalopride will help to improve the lives of these patients both in Europe and worldwide.
Prucalopride is a novel enterokinetic treatment, and the first compound in a new generation of selective, high-affinity 5-HT4 receptor agonists, specifically designed to restore impaired bowel motility and help patients with chronic constipation for whom laxatives do not provide adequate relief. By direct action on the wall of the gut, prucalopride offers a novel approach to a debilitating disease. Prucalopride has completed three identically designed Phase III studies and has been tested in more than 3,000 patients. Movetis filed for marketing approval in May 2008 in Europe and is currently under review by the EMEA and Swissmedic.
About chronic constipation
Chronic constipation is a general disorder of the gastrointestinal tract that affects an estimated 80 million people worldwide and at least 37 million in Europe(1). It is a prevalent and debilitating condition with a clear impact on quality of life. 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 many cases available prescription or over the counter drugs, offer inadequate treatment. There is need for an alternative and novel approach to help chronic constipation patients.
Through a clear focus on gastroenterology (GI), 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 one product for which the marketing application was filed, two products in clinical development, one product ready to move into clinical development and four in preclinical, all addressing important GI areas including chronic constipation, ascites, paediatric reflux in infants, diabetic gastroparesis, specific subgroups of patients with severe forms of irritable bowel syndrome or dyspepsia. In addition, Movetis has rights to a large library of qualified lead compounds with potential for development in different GI indications and access to know how for compounds in secretory diarrhoea. The current portfolio has been licensed from Janssen Pharmaceutica NV, Belgium and Ortho-McNeil Pharmaceutical Inc., two Johnson Johnson (JJ) companies.
The current portfolio includes:
- Prucalopride, which has completed clinical development for chronic constipation and has been filed with the EMEA and Swiss health authorities. - M0002 is in Phase II clinical development for ascites - M0003 is in clinical development for gastroparesis and paediatric reflux. - M0004 is ready to go into clinical development for refractory GORD and/or non erosive reflux disease (NERD); - four compounds in preclinical development; - two compound libraries, each with more than 600 ligands.
(1) Reyn. D. Opportunities in gastroenterology. Drug Discovery World - Winter 2007/8.
(2) Drossman (2006) Rome III: The new criteria. Chinese Journal of Digestive Diseases 7 (4) , 181-185
Ingrid Jansen Company Communication Manager Tel: +32-14-404-360 Mobile: +32-494-707-459 Ingrid.Jansen@movetis.com
Ingrid Jansen, Company Communication Manager, Tel: +32-14-404-360, Mobile: +32-494-707-459, Ingrid.Jansen@movetis.com