Two Movetis Compounds Successfully Progressing Through Phase II Clinical Trials In Gastrointestinal (GI) Disorders

Main Category: GastroIntestinal / Gastroenterology
Also Included In: Clinical Trials / Drug Trials
Article Date: 08 Jan 2008 - 13:00 PDT

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Turnhout, 08 January 2008, Movetis NV, a European-based specialist pharmaceutical company, announced today that M0002, an orally-active selective V2 vasopressin antagonist for the treatment of ascites has successfully completed enrollment in a Phase IIa clinical trial, and that M0003, an innovative gastrokinetic compound for the treatment of paediatric reflux and gastroparesis has now begun a Phase IIa clinical trial in patients with gastroparesis.

M0002 is an aquaretic, electrolyte-sparing treatment that promotes the excretion of bodily water without extra loss of sodium. It is currently being studied for the treatment of ascites or accumulation of water in the abdomen of patients with liver cirrhosis as a result of hepatitis C or alcoholism. M0002 has the potential to reduce the number of invasive hospital procedures (paracenthesis) currently used to reduce the accumulation of water in the abdomen. Trial results for M0002 to date show that it is well tolerated and maintains aquaretic activity in healthy volunteers. Single dosing of M0002 in cirrhotic patients resulted in a significantly increased output of diluted urine. Results from the Phase IIa clinical trial are expected to be available at latest by the end of Q2 2008.

M0003 is a powerful, and specific, high affinity 5-HT4 agonist that stimulates upper GI motility and accelerates gastric emptying at low dose. It is currently being studied for the treatment of gastroparesis, a disorder in which the stomach takes too long to empty its contents, as well as paediatric reflux, or involuntary regurgitation of gastric contents into the oesophagus. Results from the Phase IIa clinical trial of M0003 in gastroparesis are expected in 2009.

In a further boost to its commitment to bring innovation back to GI, Movetis was granted 1.67 million Euros by the Institute for the Promotion of Innovation by Science and Technology in Flanders (IWT) at the end of 2007 to support early and innovative development for M0002 and start discovery efforts with its library of 5-HT4 agonists.

'We are encouraged to see that our compounds are successfully progressing through research on time and within budgets. Obviously we are honoured that the IWT institute feels our programme merits such a grant and we are committed to work with them to progress innovation and create jobs in our region." commented Dirk Reyn, CEO of Movetis "Through these grants and the support of our distinguished investors, we can pursue our path to discover, develop and ultimately commercialise innovative treatments targeting selected GI conditions where patients do not get adequate relief from older drugs with less favourable benefit/risk profiles" .

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 that have recently benefited less from 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 aiming to address important areas of unmet medical need, including chronic constipation (CC), ascites, paediatric reflux, diabetic gastroparesis, specific subgroups of patients with severe forms of IBS or dyspepsia and secretory diarrhoea. In addition, Movetis has rights to 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, which has completed 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 and gastroparesis, which has recently entered Phase IIa clinical trials in gastroparesis

- M0004, another gastrokinetic compound for nocturnal heartburn and other 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.

Movetis NV