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Trophos starts phase II clinical trial of TRO19622 in liver disease

Marseille, May 15th, 2008 - Trophos SA, a biopharmaceutical company specializing in the discovery and development of drugs for neurological disorders, announced today that the first patients with NonAlcoholic SteatoHepatitis (NASH) have been enrolled in an exploratory Phase IIa clinical trial of its lead product, TRO19622. It is the first study investigating the potential benefits of TRO19622 beyond neurological conditions.

The randomized, double-blind, placebo-controlled, single dose trial will compare the efficacy of TRO19622 to placebo after 4 weeks of treatment in 30 patients with NASH. The exploratory study will assess the safety, tolerability and short term effect of 500mg TRO19622, once-a-day, on circulating liver enzymes and biomarkers of oxidative stress and apoptosis. The study is being conducted at centers in France and is expected to be completed in Q4 2008.

TRO19622 is representative of novel compounds identified using the proprietary neuronal cell screening platform developed at Trophos. Preclinical studies have demonstrated that these compounds promote the function and survival of neurons, cardiomyocytes and hepatocytes under various disease-relevant stress conditions, via a mitochondria-based mechanism of action. TRO19622 has successfully completed Phase I/Ib studies in both healthy volunteers and ALS patients, demonstrating the product is well tolerated, has an excellent safety profile and that once-a-day dosing achieves the predicted exposure level required for efficacy, based on preclinical models.

'The opportunity to perform this exploratory Phase IIa study with TRO19622 in patients with liver disease is a very significant event for the company, as it will provide evidence that the mechanism of action of this class of compounds will have therapeutic and commercial potential beyond neurological conditions,' said Antoine Béret, CEO of Trophos. 'Their mechanism of action and a battery of preclinical studies support the clinical evaluation of compounds in this class as treatments for liver disease, chronic neurological disorders and conditions involving ischemia-reperfusion injury, all indications with significant unmet medical needs and tremendous commercial potential.'

About NonAlcoholic SteatoHepatitis (NASH):
NonAlcoholic SteatoHepatitis is a 'silent' liver disease characterized by fatty infiltration of the liver together with signs of inflammation and hepatocyte injury. NASH affects 2 to 5 per cent of Americans and the worldwide increase in obesity and diabetes has resulted in NASH rapidly becoming recognized as one of the major and most prevalent causes of liver disease, ranking in the top three hepatopathies in different countries and ethnic backgrounds. While diet and lifestyle changes are always recommended, lack of compliance can result in NASH patients failing to achieve these objectives. NASH can lead to cirrhosis (est. 20% of cases) and ultimately to permanent liver damage & failure (est. 2-3% of cases), with organ transplantation the only treatment option. Hepatoprotection in patients with NASH is a significant unmet medical need and there is no approved treatment that decreases hepatic cytolysis or prevents fibrosis. For additional information on NASH see

About Trophos:
Trophos is a biopharmaceutical company committed to the discovery and development of novel therapeutic compounds to treat neurological disorders and other diseases with high unmet medical needs. The Trophos discovery strategy has enabled it to develop a portfolio of proprietary products, such as its lead product TRO19622 and drug candidate TRO40303, that confer a survival benefit to stressed neuronal and non-neuronal cells. This is achieved through a mitochondria-based mechanism of action with a robust scientific rationale predicted to exhibit therapeutic benefits in diseases such as neuropathic pain, ischemia-reperfusion injury and hepatotoxicity. T

Publisher Contact Information:

Andrew Lloyd & Associates
+44 1273 675100

Company profile of Trophos SA
Past press releases of Trophos SA.


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