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Neurodegenerative disease specialist completes enrolment of first 90 patients in European Phase II trial of lead molecule expected to have wide applicability in painful neuropathy
MAREILLA, France | January 18, 2008 | Trophos SA, a biopharmaceutical company specializing in the discovery and development of drugs for neurological disorders, announced today that it recently completed the enrolment of the first 90 patients in a Phase IIa clinical trial of its of lead product, TRO19622.
The randomized, double-blind, placebo-controlled, single dose study will compare the efficacy of TRO19622 to placebo after 6 weeks of treatment in a total of 180 patients with painful diabetic neuropathy. The primary endpoint of the trial will be symptomatic pain relief as measured on the 11 point Likert scale on daily diary, as well as a number of other pain scales. The trial is based in Europe and is being conducted at centres in Germany, Serbia, Croatia, and Latvia. The study is expected to be completed in 1H 2008, with results available in the 2H 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 and other cell types under disease relevant stress conditions. More specifically, studies employing widely accepted in vivo models of diabetic and chemotherapy-induced neuropathic pain support the clinical evaluation of TRO19622 as an effective treatment for both the pain and underlying neuropathy associated with these diseases. TRO19622 has successfully completed Phase I/Ib studies in healthy volunteers and ALS patients. These clinical trials demonstrated that the product is well tolerated and has an excellent safety profile, and that once-a-day oral dosing achieves the predicted exposure level required for efficacy, based on preclinical models.
"Reaching this mid-point represents a significant milestone for Trophos in the execution of our Phase IIa clinical trial in painful diabetic neuropathy, an indication with tremendous commercial potential," said Jean-Louis Abitbol, CMO at Trophos. "The inclusion of additional countries and centres in the trial is expected to maintain the pace of enrolment. We now expect the trial to complete towards the end of 1H 2008, with top line results to follow shortly thereafter."
Antoine Béret, CEO at Trophos added: "The preclinical profile of TRO19622 in neuropathic pain, in particular the potential to address the underlying neuropathy as well as provide pain relief, has generated significant interest in discussions with potential partners. TRO19622 represents a significant therapeutic advance and attractive commercial profile compared to current therapies for these indications."
About neuropathic pain
Neuropathic pain can be defined as a pain, caused by nerve injury, which is often difficult to treat and does not respond to treatments effective in other types of pain. The global prevalence of neuropathic pain is believed to be at least 2.4%, and greater in those over 55 years of age. Diabetic neuropathies are a family of nerve disorders caused by diabetes leading to numbness, weakness and sometimes pain in the hands, arms, feet and legs. About 15 percent of diabetics in the USA (about 3 million people) are thought to experience diabetic nerve pain. The market for neuropathic pain treatments is estimated at around US$ 2.5 billion and growing.
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 upon stressed neuronal and non-neuronal cell types (such as cardiomyocytes & hepatocytes). This is achieved through a mitochondria-based mechanism of action with a robust therapeutic rationale predicted to exhibit a therapeutic benefit in diseases such as neuropathic pain, ischemia-reperfusion injury and hepatotoxicity. The company is focusing its efforts on the orphan indicates ALS and SMA while seeking to establish clinical proof of concept and partnerships in other indications, such as neuropathic pain, ischemia-reperfusion injury and hepatotoxicity. The company is currently performing two clinical studies with TRO19622, a Phase IIa trial in painful diabetic neuropathy and a Phase Ib study in SMA.
Trophos was founded in 1999, is based in Marseille, France and currently has 32 employees.
SOURCE: Trophos SA |
