Neuren initiates phase II trial

Auckland biopharma Neuren Pharmaceuticals (ASX: NEU) has begun to recruit the 30 patients who will take part in its phase II pharmacokinetics and safety trial of its lead drug Glypromate. The trial will take place at multiple sites in Australia and New Zealand including the Alfred Hospital in Melbourne and at the Auckland City Hospital, the Mercy Ascot Hospital, Waikato Hospital and Wakefield Hospital in New Zealand in preparation for phase III trials next year.

"We chose multiple sites as an investment to prepare for larger phase III trials. We are looking at developing skill sets and the relationships both clinically and contractually to make the phase III trials run as smoothly, effectively and event free as possible," said Neuren CEO David Clarke. The trial is aimed at confirming the pharmacokinetic profile and safety of Glypromate ahead of a phase III trial that will assess the effectiveness of the compound as a protection from neurocognitive disturbance following coronary artery bypass graft surgery (CABG). Impaired cognition is a known complication of CABG. In June 2005 Neuren announced that following the successful completion of the phase II trial and other phase III prerequisites, the company will file with the US Food and Drug Administration to proceed directly to a phase III major efficacy study, thereby avoiding a phase IIb trial. If this is accepted by the FDA Neuren will not have to undertake a phase IIb trial, which normally cost an estimated AUD$6-8 million, and will progress to phase III in 2006 rather than 2008.

"This time next year we plan to be running both phase III trials of Glypromate and phase II trials for NNZ-2566 in brain-trauma patients. It is likely we will take one more compound into clinical trials and the rest will be either partnered or out-licensed through the clinical development process", said Clarke.