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news.Phytopharm has received FDA approval for its investigational new drug (IND) application of pharmaceutical candidate Cogane for the treatment of Parkinson's disease. The FDA has agreed the protocol for the Phase II proof of concept trial with Phytopharm.
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The study is expected to evaluate the efficacy, safety and tolerability of Cogane, administered for 28 weeks to patients with early stage Parkinson’s disease.
The primary endpoint for the study is expected to be the change in activities of daily living and motor function as measured by the Unified Parkinson’s Disease Rating Scale (UPDRS) Parts II and III.
According to Phytopharm, the change in the activities of daily living and motor function as measured by the Unified Parkinson’s Disease Rating Scale (UPDRS) Parts II and III is the primary endpoint of the trial.
The Phase II study’s other efficacy endpoints include assessment of cognitive function and quality of life. Safety assessments include standard ECG assessment, effects on blood pressure and pulse, and haematology and clinical chemistry monitoring.
Phytopharm said that preparatory work is continuing with CROs who are expected to conduct the study on behalf of the company.
Sandy Morrison, interim CEO of Phytopharm, said: “This IND for Cogane is an important milestone for Phytopharm. It confirms the quality of our preclinical data and development plan.
“We look forward to the enrolment of patients in this Phase II trial, but recognise that it will be about 2 years before we have definitive results from the study.”