Trophos Completes Enrolment Of Phase II Clinical Trial Of TRO19622 In Painful Peripheral Diabetic Neuropathy
Trophos SA, a biopharmaceutical company specializing in the discovery and development of drugs for neurological disorders, announced that it has completed the enrolment of 180 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 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 centers in Germany, Poland, Serbia, Croatia, and Latvia. The study is now expected to be completed in Q3 2008, with results available in Q4 2008.
TRO19622 is representative of novel cholesterol-like compounds targeting the mitochondria that were identified in 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 the underlying peripheral neuropathy associated with these diseases (Bordet et al., JPET, in press, available online in Fast Forward section at http://jpet.aspetjournals.org).
TRO19622 has successfully completed Phase I/Ib studies in healthy volunteers and ALS patients. These clinical trials demonstrated that the product is well tolerated, has an excellent safety profile and that once-a-day oral dosing achieves the predicted exposure level required for efficacy, based on preclinical models. The company is currently performing three clinical studies with TRO19622: a Phase Ib study in Spinal Muscular Atrophy (SMA) and two Phase IIa trials in painful diabetic neuropathy and nonalcoholic steatohepatitis (NASH).
"Completing enrolment into this Phase IIa clinical trial in painful peripheral diabetic neuropathy, an indication with tremendous commercial potential, represents a significant clinical milestone for Trophos," said Jean-Louis Abitbol, CMO at Trophos. "We now expect the trial to complete in Q3 2008, with top line results to follow shortly thereafter."
Antoine Béret, CEO of Trophos added: "The preclinical profile of TRO19622, a new class of analgesic that has the potential to address the underlying peripheral neuropathy, has generated considerable interest in discussions with potential partners. TRO19622 represents a significant therapeutic advance with an attractive commercial profile compared to current therapies for neuropathic pain."
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 around USD 4.0 billion and growing.
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 neurodegenerative diseases and indications such as ischemia-reperfusion injury and hepatitis. 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. Trophos is currently performing three clinical studies with TRO19622: a Phase Ib study in SMA and two Phase IIa trials to assess i) the analgesic effect in patients with painful diabetic neuropathy and ii) the effect on circulating liver enzymes, markers of oxidative stress and apoptosis in patients with NASH, respectively.
Trophos was founded in 1999, is based in Marseille, France and currently has 32 employees.