Movetis Files RESOLOR(R) With EMEA For The Indication Of Chronic Constipation

Main Category: GastroIntestinal / Gastroenterology
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 29 May 2008 - 16:00 PDT

email to a friend   printer friendly   view / write opinions   rate article

Movetis announced that the European Medicines Agency (EMeA) has accepted the Marketing Authorization Application (MAA) submission for RESOLOR® (prucalopride) as a treatment for chronic constipation in adults in whom laxatives fail to provide adequate relief.

RESOLOR is a new selective, high affinity 5-HT4 receptor agonist, which has the potential to improve the symptoms of people with abnormalities in gastrointestinal (GI) motility by restoring the smooth functioning of the lower GI tract.

Chronic constipation affects more than 80 million people worldwide1, of which 37 million live in the European Union, and poses a significant burden for those it affects. In Europe, many patients frequently visit their doctors with complaints of chronic constipation after dissatisfactory results with over-the-counter medication, primarily because of a lack of efficacy.

The application for marketing authorization is supported by an extensive clinical development programme consisting of three identical Phase III studies and by data derived from a comprehensive clinical trial programme including an additional 79 studies, which fully explored the clinical profile of RESOLOR for a variety of medical needs and patient populations. The studies also offer a robust and in depth evaluation of safety, pharmacokinetics, potential for drug interactions, bioequivalence and pharmacodynamics.Total RESOLOR exposure in the programme exceeds 3000 patients and 2,500 patient years.

"The RESOLOR filing is a major milestone for Movetis and demonstrates our commitment to providing an effective treatment for patients with chronic constipation," said Dirk Reyn, CEO of Movetis. "Despite the millions of patients worldwide who visit their doctors seeking help after unsatisfactory results with over-the-counter medicines, chronic constipation remains overlooked and the impact of the condition underestimated. We look forward to working with the Regulators as we progress through the registration process."

Studies submitted in the filing

The three pivotal studies were randomised, parallel-group and placebo-controlled, with a run-in period of two weeks and a treatment period of 12 weeks. The primary efficacy endpoint in these studies was the proportion of patients with a mean of three or more spontaneous complete bowel movements (SCBMs) per week over the 12 weeks of the study. A bowel movement was defined as spontaneous if no laxatives were taken in the 24 hours preceding the bowel movement. This is in line with the EMEA Scientific Advice that was obtained, and from a clinical perspective would be considered to equate to normalisation of bowel movements.

The RESOLOR studies also assessed a wide range of secondary endpoints covering bowel movements, symptoms and disease-related quality of life, including overall satisfaction with treatment.

About RESOLOR

RESOLOR 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. 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. The Marketing Authorization Application was submitted with EMeA 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 is 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 week2. In Europe, an estimated 10 million patients frequently visit their doctors with complaints of constipation after dissatisfactory results with over-the-counter medication3. 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 and four in preclinical development, all addressing important GI areas with fewer innovative products, including chronic constipation, ascites, paediatric reflux in infants, diabetic gastroparesis, non erosive and refractory reflux disease, post-infectious IBS and secretory diarrhoea. In addition, Movetis owns a large library of qualified lead compounds for further 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 chronic constipation currently under review for Marketing Authorisation in Europe.

- 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 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).

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 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. http://www.movetis.com

References

1. Reyn D. Opportunities in Gastroenterology. Drug Discovery World Winter 2007/8.
2. Drossman A (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.

http://www.movetis.com