M0003

Next Generation Gastrokinetic for Refractory Gastro-Oesophageal Reflux Disease (GERD) and Paediatric Reflux

Movetis is developing M0003 for the treatment of upper GI disorders focusing initially on patients with symptoms of GERD (such as heartburn and regurgitation) after insufficient response or with intolerance to proton pump inhibitors (PPI) treatment (refractory GERD) and on paediatric reflux in infants.

M0003 is a novel chemical entity which binds potently and selectively to 5-HT4 receptors in the upper GI tract. It has been shown to promote more pronounced and coordinated movements of the oesophagus and the stomach (gastrokinetic).

Potential market

Movetis believes that refractory GERD is an attractive indication for M0003 as there is a large group of patients, a high unmet medical need and favourable pricing and reimbursement environment. Movetis estimates that there are 90 million adult patients in the EU and the US with GERD.

Approximately 25% of GERD patients treated with PPI's (approximately 50% of all GERD patients) in the EU and the US (or 11.9 million patients) have currently been defined to be inadequately treated for their symptoms, with PPIs, double dose PPIs, long acting PPIs or with combined H2 receptor antagonists and PPI treatment. Furthermore, this patient population has been recognised by the EMEA and novel therapies focusing on motility-related mechanisms have been suggested in discussions on new guidelines for the treatment of GERD (February 2009).

Development status

A broad range of in vitro and in vivo cardiovascular and electrophysiological preclinical studies suggest the cardiovascular safety of M0003. The preclinical and early clinical program has also confirmed that the compound has a clean cardiovascular and CNS profile.

The next step in the  will be to further characterise the refractory GERD patient population via surveys and mechanistic studies and by assessing the potential effect of the product on LESP, TLESRs and oesophageal and gastric function. These studies will start in H1 2010 and are expected to be followed by a Phase II proof of concept study in GERD patients in H2 2010.

Commercial rights

Movetis has exclusive commercial rights in EU countries (excluding Bulgaria and Romania), Switzerland and Liechtenstein, Canada and the US for all indications, while Johnson & Johnson has the commercial rights in the rest of the world.