Trophos Starts Phase II Clinical Trial Of TRO19622 In Painful Diabetic Neuropathy

Main Category: Diabetes
Also Included In: Clinical Trials / Drug Trials
Article Date: 18 May 2007 - 12:00 PDT

email to a friend   printer friendly   view / write opinions   rate article

Trophos SA, a biopharmaceutical company specializing in the discovery and development of drugs for neurological disorders, announced today that the first patients have been enrolled 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 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 18 centers in Germany, Poland and Serbia. The study is expected to be completed in 1H 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 survival of a wide range of neurons under disease relevant stress conditions. Data from preclinical studies employing widely accepted in vivo models of diabetic and chemotherapy-induced neuropathic pain supports the clinical evaluation of TRO19622 as an effective treatment for neuropathic pain. 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.

"It is a very exciting time for the company as our lead product, TRO19622, enters its first proof of concept efficacy trial in the clinic for painful diabetic neuropathy, an indication with tremendous commercial potential," said Antoine Béret, CEO at Trophos. "Furthermore, based on the mechanism of action and a battery of preclinical studies in both neuronal and non-neuronal cell types, there is increasing evidence to support the clinical evaluation of compounds in this class as treatments for other chronic neurological disorders and conditions involving ischemia-reperfusion injury and hepatotoxicity."

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 percent, 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 about USD 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. Trophos has pioneered an innovative phenotypic screening platform which has enabled it to develop a proprietary portfolio of products, such as our lead product TRO19622, that confer a survival benefit upon both neuronal and non-neuronal cell types (such as cardiomyocytes & hepatocytes) through a mitochondria-based mechanism of action with a robust therapeutic rationale, one that is 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, SMA & Huntington's disease while seeking to establish clinical proof of concept in other indications, such as neuropathic pain, ischemia-reperfusion injury and hepatotoxicity. www.trophos.com

Trophos was founded in 1999, is based in Marseille, France and currently has 32 employees.