FDA advances Neuren's Phase III to next year

NZ-based Neuren (ASX:NEU) has received confirmation from the US Food and Drug Administration (FDA) that the company can bypass a previously planned Phase IIb study for its lead drug Glypromate and advance directly to a major Phase III efficacy study.

Glypromate is a naturally-occurring peptide fragment found in normal brain tissue. The Phase III trial will assess Glypromate's effectiveness in protecting brain tissue from disturbance following coronary artery bypass grafting surgery.

The trial is expected to begin in 2006, rather than 2008, once the company completes a small Phase IIa trial, involving 30 patients and scheduled for completion at the end of 2005, plus other standard prerequisites.

Neuren CEO David Clarke said the Phase III trial would require more precursors -- the company will need to collate a drug master file, complete a drug stability study, stress tests, have fully documented QA systems, have formulations in manufacturing inspected and audited, and complete additional toxicology tests.

However, Clarke said, Neuren will only need three months to complete these precursors, as well as those the company had already planned for Phase IIb trials. "It means that we'll just have to bring that forward the money we were going to have to spend if we were going to Phase II," said Clarke. "We'll save the IIb costs, which won't be insubstantial -- it's about AUD$6 million."

The Phase III trial will involve 400 to 500 patients, a similar number of patients to the planned IIb trial.

Clarke said that the FDA looked at the science, the clinical packaging, the design of the trial and the compound safety of Glypromate before deciding that a Phase IIb trial would not be needed.

"A trial done under the FDA IND [investigational new drug] is regarded very highly by the US biotechs and US pharmaceutical companies, who are our market at the end of the day," Clarke said.

While the acceleration of the Phase III study means that Neuren may not need to partner or out-license, Clarke said that "there will be some form of capital raising -- to be determined, how and when."