Date: 2013-02-18
Type of information:
phase: 2
Announcement:
Company: Phytopharm (UK)
Product: Cogane™ (smilagenin)
Action
mechanism: Cogane® is a member of the sapogenin class of compounds. This orally bioavailable neurotrophic factor inducer readily crosses the blood-brain barrier. It has demonstrated neuroprotective effects in a range of preclinical models of neurodegenerative diseases. Specifically, it has been shown to induce and modulate the production of neurotrophic factors. The neuroprotective and neurotrophic actions of Cogane® suggest potential beneficial effects in a range of neurodegenerative diseases, including Parkinson’s disease and orphan diseases such as ALS.
Disease: Parkinson\'s disease
Therapeutic area: Neurodegenerative diseases - CNS diseases
Country: USA, Canada, Czech Republic, France, Germany, Hungary, Poland, Romania, Serbia, UK
Trial details: 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-of-treatment for each dose of Cogane™ vs. placebo. (NCT01060878)
Latest
news: * On February 18, 2012, Phytopharm has announced the results of the Phase II, randomised, double blind, placebo controlled, dose-ranging 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.
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-of-treatment for each dose of Cogane™ vs. placebo. 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.
During the coming weeks Phytopharm will further analyse these results with its scientific advisors to better understand whether to continue the development of Cogane™ and Myogane™, both members of the sapogenin class of compounds. In addition, a review of other strategic options for the Company will be initiated by the Board and no further R&D expenditure will be committed whilst this review is taking place.
