Phytopharm plc announced the results of the Phase 2, randomized, double blind, placebo controlled, doseranging trial of Cogane in unmedicated patients with early-stage Parkinson’s disease (“CONFIDENT-PD”).
Analysis of the headline results indicated that Cogane had no beneficial effects on patients’ symptoms measured by the primary or secondary endpoints in the study.
Over four hundred subjects with early-stage Parkinson’s disease were randomly allocated to receive either Cogane 60 mg, 120 mg or 180 mg, or placebo, which was taken orally, once daily for up to 28 weeks. Measurements were taken during the study to determine the efficacy, safety and tolerability of each dose of Cogane compared with placebo and also the systemic exposure to Cogane.
The prospectively defined primary endpoint in this study was the change in the combined UPDRS II/III (an assessment of activities of daily living and motor symptoms) score from baseline to end-oftreatment for each dose of Cogane vs. placebo. A number of secondary efficacy outcome measures were also explored.
No statistically significant effects or trends towards improvement were seen in any of these endpoints. Analysis of the results indicates that the study was well conducted and gave a clear, albeit negative result.
Review of the safety data confirmed that Cogane administered orally once daily for up to 28 weeks was well tolerated. The full results of the study will be published in an appropriate scientific forum in due course.
Professor C Warren Olanow, Professor of Neurology and Neuroscience at Mount Sinai Medical School and Co-chief Investigator for the study commented: “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. Sadly, the results are negative. Nonetheless, the search for more effective therapies for the millions of patients who suffer from Parkinson’s disease must continue.”
Commenting on these results, Tim Sharpington, CEO said: “We are naturally disappointed with the outcome of this study of Cogane in patients with Parkinson’s disease. 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. I would like to thank the investigators who conducted the trial, our collaborators and especially the patients who participated in the study, along with the Parkinson’s disease community and all our stakeholders who have supported the development of Cogane. During the coming weeks we will further analyse these results with our scientific advisors to better understand whether to continue the development of Cogane and Myogane. In addition, a review of other strategic options for the Company will be initiated by the Board and shareholders will be kept informed of progress. No further R&D expenditure will be committed whilst this review is taking place.”
Date: February 19, 2013