Successful completion of Phase Ib study in AD and PD drugs

Phytopharm has successfully completed a phase Ib clinical study of its orally active synthetic neuroprotective and neuroregenerative product, PYM50028, which is under development as a treatment for a range of neurological disorders, including Alzheimer's and Parkinson's diseases (programmes P58 and P63, respectively).

This study utilised a randomised, double blind, placebo controlled design to examine the safety, tolerability, pharmacokinetics and cognitive effects of PYM50028. Thirty healthy men and women aged 50 years and older were enrolled and randomly allocated to receive either PYM50028 or placebo once daily for 28 days. Results indicate that the product has absorption and pharmacokinetic characteristics suitable for once-daily dosing and is well tolerated with a good emergent safety profile. A phase II clinical study in Alzheimer's patients is now anticipated to begin shortly, during which PYM50028 will be compared with placebo over a three-month dosing period.

The phase Ib data have now been submitted to Yamanouchi Pharmaceutical, the results of which are the subject of the second milestone payable under the licence agreement announced on 1 May 2003 between Yamanouchi and Phytopharm for marketing of PYM50028 in Japan and some other Asian countries. A total of US$33m in milestones was specified in the agreement, subject to the achievement of specific objectives, of which $17m will be potentially payable to Phytopharm over the next 18 months. Phytopharm will also receive royalties on the sale of PYM50028 by Yamanouchi.

Dr Richard Dixey, chief executive of Phytopharm, said: 'We are making rapid progress in the development of PYM50028 and are encouraged with the dosing profile of this product.'