Trophos SA, a biopharmaceutical company specializing in the discovery and development of drugs for neurological disorders, said it recently completed the enrolment of the first 90 patients in a phase IIa clinical trial of its of lead product, TRO19622.
The randomised, 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, 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."
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.