M0004

Next generation gastrokinetic for Non-Erosive Reflux Disease

M0004 is, along with M0003, part of our “next generation gastrokinetic” development programme at Movetis. M0004 is a specific and high-affinity 5-HT4 receptor agonist that acts on the motility of the upper gastrointestinal tract. It is considered for development in the treatment of bloating, heartburn, fullness and nausea in patients with refractory gastro-oesophageal reflux disease (GERD) or Non-Erosive Reflux Disease (NERD).

Potential market

Despite the widespread use of PPIs (proton pump inhibitors), which is currently probably the best medical therapy for the majority of GERD patients, there remains a persistent medical need in a large group of them.

Older, non-specific 5-HT4 agonists have shown reduction in reflux episodes and heartburn. With a more targeted and specific 5-HT4 profile and improved benefit/risk profile, M0004 may be able to help those patients where current PPI treatment is not sufficient.

In in vitro models, M0004 is hardly susceptible to metabolism, suggesting a longer half-life, which we believe would be a significant competitive advantage.

Development status

We have completed initial toxicology studies, which show a high safety margin and support progressing M0004 into human testing in 2009. We intend to undertake further long-term toxicology testing as part of the continuing development process.

Based upon the medical need, we believe that a gastrokinetic such as M0004 has two potential development paths: as a monotherapy in patients with Non-Erosive Reflux Disease (NERD); or as a combination therapy with PPIs in patients with refractory GERD not adequately controlled with standard PPI regimens.

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.