Pharmaxis' Aridol trial meets its endpoints

Pharmaxis (ASX: PXS) has achieved a major milestone with the successful completion of the Phase III clinical trial for its asthma diagnostic and treatment management tool Aridol.

"[The trial] met all its endpoints," said CEO Alan Robertson. "Needless to say, we're very happy with the result."

The company will now focus on filing for registration in Australia and then in Europe, with an expected launch date for the product in Australia in mid-2005.

Aridol is an inhalable dry powder administered via a handheld device, which can be used to identify patients with active asthma, providing information on the severity of the disease and effectiveness of the current treatment regime.

Among the significant outcomes of the trial was the finding that up to 25 per cent of patients were not being adequately treated for asthma and should have their treatment increased or changed to improve control of the disease. Another 17 per cent of patients could have their medication decreased without adverse effects.

"It's set to change the way asthma is managed worldwide," Robertson said.

He noted that the company was continuing to analyse the data from the 646 patient open label, blinded, randomised, crossover trial.

According to Robertson, the company has a number of hurdles to overcome before next year's launch, in addition to filing for regulatory approval. The TGA-approved manufacturing capability is being expanded to allow production of up to one million Aridol kits annually, up from the current level of 300,000.

"This should take us out to two years post the launch," he said.

The company is also working to establish a sales and marketing team, and to secure distribution arrangements for Europe and later for the US.

Further trials are taking place in Europe at present, and a US clinical trial, which is likely to focus on comparing Aridol with the approved diagnostic test used in the US, is planned for early 2005. US approval will be sought following the trial in late 2005 for a probable US launch in 2006.

The share market reacted positively to the news of the trial results, with heavier than average trading. At the time of writing, Pharmaxis shares were trading at $0.87, up 11.5 per cent from the previous close.