Shares in Phytopharm Plc (LON:PYM) edged up 10% to 9.6p this morning after the drugs developer said a investigational new drug (IND) application for its lead pharmaceutical candidate Cogane for the treatment of Parkinson's disease had been granted by the US Food and Drug Administration (FDA). The FDA has agreed the protocol for the Phase II proof of concept trial with Phytopharm, which will look at the efficacy, safety and tolerability of Cogane administered for 28 weeks to patients with early stage Parkinson's disease. Definitive results from the trial are expected to take two years to come through.

Shares in Phytopharm soared from 5p to 26p last October on the back of positive results from two key studies into the efficacy and safety of Cogane. Shortly afterwards the company raised £24.1m in a placing and open offer priced at 10p per share to fund Phase II studies of the drug.

The main aim of the study will be to identify 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. 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. The study will be conducted in a number of countries, including the USA and the UK, and regulatory submissions in the other countries will be submitted shortly. The company said it expects recruitment of patients into the study to begin in the next six months.

Sandy Morrison, Phytopharm’s interim chief executive, 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 two years before we have definitive results from the study. Nevertheless this is an important next step towards bringing a potentially disease-modifying new therapy for Parkinson's disease closer to market fruition.”

Unlock the rest of this article with a 14 day trial

Already have an account?
Login here