Road clear for Neuren phase III trials
Wednesday, 01 February, 2006
The US FDA has given the all-clear for Auckland biopharma Neuren Pharmaceuticals (ASX:NEU) to move straight into a phase III major efficacy trial for lead molecule Glypromate.
Neuren CEO David Clarke said the company had put together a package of preclinical data for the FDA from its ongoing phase II trials of Glypromate. "We put the package together and everything went well, there is a great feeling of relief," Clarke said. "Even though you have a gold standard in clinical trials you never know until it happens."
According to Clarke, Neuren is on target to announce the results of its phase IIa pharmacokinetics and safety trial of Glypromate in its first indication as a protection from neurocognitive disturbance following coronary artery bypass grafting surgery in March/April this year.
The phase III trial is scheduled to start in the last quarter this year and will take place in sites in the US, Australia, New Zealand and the UK.
Following a meeting with the FDA in April 2005, it was agreed that Neuren would conduct additional work that would enable the company to move Glypromate directly into a pivotal FDA phase III trial, avoiding a phase IIb trial and saving Neuren approximately $6-8 million and two years in the development program.
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