Phytopharm has announced results of its Phase II, randomised trial of Cogane in unmedicated patients with Parkinson's disease.
More than four hundred subjects with early-stage Parkinson's disease were randomly chosen to receive either Cogane in various sizes or placebo for 28 weeks, with measurements taken to determine the efficacy, safety and tolerability of each dose.
The primary endpoint in this study was the change in combined UPDRS II/III (an assessment of daily living and motor systems) score, ranging from baseline to end-of-treatment for each dose of Cogane vs placebo.
Cogane has been known to demonstrate neuroprotective and neurorestorative properties in a number of models of Parkinson's disease.
A review of the safety data showed that, when taken orally once a day for up to 28 weeks, Cogane was well tolerated, though it was found to be no more effective than placebo.
Professor C Warren Olanow, professor of Neurology and Neuroscience at Mount Sinai Medical School and co-chief Investigator for the study, said: "This is disappointing news for the Parkinson disease community. Trophic factors that enhance and restore function to remaining nerve cells is an extremely promising approach for the treatment of neurodegenerative disorders such as Parkinson's disease.
"Cogane offered the potential of providing trophic effects throughout the brain with an oral medication that was relatively safe and well tolerated. The company is to be congratulated for carrying out this important study in such a high quality manner."
Tim Sharpington, chief executive of Phytopharm, also commented on the news, expressing his disappointment with the study.
"Cogane had demonstrated encouraging efficacy in a wide range of industry standard pre-clinical models but this promise has not translated into clinically meaningful efficacy in this study," Mr Sharpington stated.
He went on to thank the investigators and patients for taking part in the trial.
Phytopharm is set to advance studies into Cogane and Mogane in the coming weeks, while a review of the company's strategic options will always take place.
