Phytopharm suffers Parkinson’s loss
pharmafile | February 20, 2013 | News story | Research and Development, Sales and Marketing | Parkinson's, Phytopharm, cogane
Phytopharm is facing an uncertain future after the failure of one of its most promising drugs in a Phase II trial in Parkinson’s disease.
Cogane ‘had no beneficial effects’ on patients’ symptoms on both the primary and secondary endpoints in the CONFIDENT-PD study.
“We are naturally disappointed,” said the UK firm’s chief executive Tim Sharpington.
This must be an understatement since Phytopharm – whose shares are traded on the London Stock Exchange – has emphasised Cogane’s importance to its pipeline and admits that its entire future business strategy is now under review.
As of the end of January, Phytopharm had unaudited net cash and cash equivalents, which include stock market investments, of around £5.5 million.
Cogane, a once-daily oral medication, had demonstrated ‘encouraging efficacy’ in standard pre-clinical models “but this promise has not translated into clinically meaningful efficacy in this study”, Sharpington added.
More than 400 unmedicated patients in North America and Europe with early-stage Parkinson’s disease were randomly allocated to receive either Cogane 60 mg, 120 mg or 180 mg – or placebo – once-daily for up to 28 weeks.
Primary endpoint 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 versus placebo.
These activities range from routine tasks like doing up buttons and shoe laces while the motor symptoms include such elements as gait, bradykinesia, postural stability and tremor.
No statistically significant effects or trends towards improvement were seen in this or any of several secondary endpoints, which included cognitive function, depression and excessive daytime sleepiness.
Full results will be published in due course, Phytopharm says, with the review now in place concentrating on further analysis of the results plus a look at what strategic options are available to the company.
“No further R&D expenditure will be committed whilst this review is taking place,” a statement from the firm said.
Charles Warren Olanow, professor of neurology and neuroscience at Mount Sinai Medical School and co-chief investigator for CONFIDENT-PD, admitted it was “disappointing news for the Parkinson disease community”.
Cogane had offered the potential of providing trophic effects – which enhance and restore function to remaining nerve cells throughout the brain – and was an ‘extremely promising approach’, he added.
This therapy area remains of great intrest to pharma companies: last July Prexton Therapeutics, which specialises in novel treatments for Parkinson’s, was spun out of Merck Serono’s R&D operations in Geneva.
Prexton focuses on developing drugs that target the metabotropic glutamate receptors mGluR3 and mGluR4.
Meanwhile in August Elan Corporation separated off its drug discovery arm Neotype Biosciences, which also focuses on chronic degenerative diseases such as Parkinson’s.
Adam Hill
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