SAN DIEGO, May 21 /PRNewswire/ --
- Three Presentations and Four Additional Posters Reinforce Efficacy and Safety Profile of RESOLOR
Movetis NV, a European-based GI specialist pharmaceutical company, today announces that it has presented substantial new data from different studies this week at the prestigious Digestive Disease Week (DDW) 2008 Congress. The data, that are part of a comprehensive development program with over 82 trials, reinforce the efficacy and safety profile of RESOLOR(R) (prucalopride), the most advanced in the class of novel and highly selective, high-affinity 5-HT4 receptor agonists that has the potential to normalize impaired lower GI motility. RESOLOR has been studied in the treatment of patients suffering from chronic constipation for whom laxatives do not provide adequate relief (1-7).
A combined analysis of three identical and pivotal phase III studies, including 1,924 patients, demonstrated that over the 12 weeks treatment period both 2 mg and 4 mg RESOLOR significantly improved bowel function (as measured by a number of rigorous primary and secondary endpoints) as well as a variety of predominant symptoms in patients with chronic constipation compared with placebo. These results are also reflected in other efficacy parameters including quality of life(1), adding support to RESOLOR data presented for the first time at UEGW (United European Gastroenterology Week) in October 2007.
Additional data over 24 months (2) presented at DDW shows that RESOLOR has a favourable safety profile and is well tolerated, and that patients' satisfaction with bowel function was maintained during this long treatment period (2). Furthermore, in a specifically designed safety trial, RESOLOR showed favourable CV safety and tolerability data (including comprehensive set of QTc measurements) at repeated doses of up to 20 mg daily - 10 times the anticipated therapeutic dose for chronic constipation (4).
Jan Tack, Professor and Head of Clinic, Division of Gastroenterology, University Hospital Gasthuisberg, University of Leuven, Belgium, and author of one of the abstracts, commented, "The debilitating effects of chronic constipation on work, mental health and relationships are often underestimated, and there is a recognised and significant unmet need for an effective treatment with a novel mechanism of action for this condition. RESOLOR's unique selectivity means it is likely to be safer than older motility agents and more effective than existing treatments, and may also potentially provide a faster return to normalized bowel health. The variety and strength of new RESOLOR data presented at DDW demonstrates how RESOLOR may potentially help fill the unmet need and offer hope towards normal bowel habits, symptom relief and improved quality of life to the many patients who suffer from the condition."
Further data were also presented on treatment with RESOLOR of various sub-populations of patients, where there remains a significant challenge of treating chronic constipation. In these studies, RESOLOR improved bowel function and was shown to be safe and well tolerated in the elderly (5), in whom chronic constipation is a common problem due to a combination of factors including reduced colonic motility. It was also safe and well tolerated in a phase II trial in Post Operative Ileus and in a phase II trial in those who receive high dose opioid medication for chronic pain, and for whom constipation is the most common and debilitating symptom. (6)
Staf Van Reet, Chairman of Movetis, added, "We are delighted that all three presentations and four abstracts submitted to DDW were accepted. The data, that are part of our overall and comprehensive development program with RESOLOR, further supports the depth of the data package, and illustrates our continued commitment to bring this product to the market and to patients with chronic constipation. Millions of people worldwide with constipation visit physicians seeking help after unsatisfactory results with over-the-counter medicines. RESOLOR is different from existing therapies in that it is expected to not only improve bowel habits in a satisfactory way but also to alleviate the broad range of symptoms in these patients with minimal side effects. We believe RESOLOR helps address this debilitating condition and may therefore improve the lives of these patients, especially those who are more challenging to treat."
About the studies presented at Digestive Disease Week
Seven abstracts (three oral presentations and four posters) were presented at DDW focusing on evaluating the efficacy and safety of RESOLOR in a wide variety of patient populations with chronic constipation (1-3,5-7), including patients that do not respond adequately to laxatives, the elderly (5) and those with opioid-induced constipation (6), and patients undergoing elective partial colectomies (7). These studies assessed a wide range of primary and secondary endpoints covering bowel movements, symptoms and disease-related quality of life, including overall satisfaction with treatment. RESOLOR was also investigated for impact on cardiovascular variables (ECG, blood pressure, heart rate, QTc) in healthy subjects at very high doses (4). In all populations, RESOLOR had a favourable efficacy and safety profile.
RESOLOR is a novel enterokinetic treatment for chronic constipation in a patient population not adequately relieved by laxative treatments. It is a highly selective, high-affinity 5-HT4 receptor agonist, which increases colon motility and restores the slow movement of the bowels in a dose-dependent manner. It is intended to become available in film-coated tablets of 1 mg and 2 mg for oral administration at a recommended dose level of 2 mg once daily (o.d.) in adults. RESOLOR has completed three Phase III studies and has been tested in more than 3,000 patients.
About chronic constipation
Chronic constipation is a disorder of the gastrointestinal tract. It is a prevalent and debilitating condition that is not always well recognized and understood and is in many cases inadequately treated. The recent 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 (8). In Europe, an estimated 10 million patients frequently visit their Doctors with complaints of constipation after dissatisfactory results with over-the-counter medication (9). Constipation is more common in women than men (estimated prevalence ratio of 2.2:1)(10).
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 and four in preclinical development, all addressing important GI areas with fewer innovative products, including chronic constipation, ascites, reflux in infants, diabetic gastroparesis, non-erosive and refractory reflux disease and post-infectious IBS. In addition, Movetis owns a large library of qualified lead compounds for further development addressing GI disorders such as secretory diarrhoea. 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 chronic constipation currently in final preparation for filing. - M0002, a selective V2 receptor antagonist compound for the treatment of ascites that has concluded a Phase IIa trial. Results are expected before the end of Q2 2008. - M0003, a gastrokinetic compound for the treatment of 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).
1. Camilleri M et al. Efficacy of 12-week treatment with prucalopride (Resolor(R)) in patients with chronic constipation: combined results of three identical randomized, double-blind, placebo-controlled phase III trials. Poster 435293, DDW 2008
2. Van Outryve MJ et al. Long-term follow-up study of oral prucalopride (Resolor(R)) administered to patients with chronic constipation. Poster 438541, DDW 2008
3. Tack JF et al. Safety and tolerability of prucalopride (Resolor(R)) in patients with chronic constipation: pooled data from three pivotal phase III studies. Poster 437976, DDW 2008
4. Boyce MJ et al. Cardiovascular safety of prucalopride (Resolor(R)) in healthy subjects: results from a randomized, double-blind, placebo-controlled, cross-over trial. Poster 430410, DDW 2008
5. Mueller-Lissner SA et al. Randomized double-blind placebo-controlled trial to evaluate efficacy and safety of prucalopride (Resolor(R)) in elderly patients with chronic constipation. Research Forum 438210, DDW 2008
6. Moulin DE et al. Randomized, double-blind, placebo-controlled trial to evaluate efficacy and safety of prucalopride (Resolor(R)) in patients with opioid-induced constipation. Topic Forum 438068, DDW 2008
7. Galandiuk S. Evaluation of the efficacy, safety and tolerability of prucalopride (Resolor(R)) given subcutaneously in patients undergoing elective partial colectomies. Research forum 438293, DDW 2008
8. Drossman A. Rome III: The new criteria. Chinese Journal of Digestive Diseases 2006; 7 (4): 181-185.
9. IMS Health
10. Higgins PD, Johanson JF. Epidemiology of constipation in North America: a systematic review. Am J Gastroenterol 2004; 99: 750-9
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