Pharmaxis completes Bronchitol trial

Pharmaxis (ASX:PXS) has wrapped up a Phase III trial of respiratory treatment Bronchitol in people with bronchiectasis.

The double blind, controlled, randomised trial involved 485 participants at 83 hospitals in the US, Europe, South America and Australia. Patients not in the control group were given 52 weeks of treatment with Bronchitol. The trial first began in October 2009.

The study’s primary endpoint was a reduction of graded pulmonary exacerbations in bronchiectasis compared to the control, with secondary measures including quality of life, sputum weight and lung function.

Pharmaxis said it aims to publish the results of the trial in the second quarter of the year.

Bronchiectasis is an obstructive lung disease characterised by irreversible dilation and scarring of part of the bronchial tree. There are no currently approved products to assist with mucus clearance.

Bronchitol is a proprietary formulation of the sugar alcohol mannitol, administered into the lungs as a dry powder. It is designed to hydrate the lungs and improve lung clearance.

Besides bronchiectasis, Bronchitol is also being positioned as a treatment for cystic fibrosis. While the product has approvals for this purpose in Australia and in the EU, and is listed on the PBS in Australia, an advisory panel to the US FDA recently recommended that Bronchitol not be approved for treating cystic fibrosis.

Pharmaxis has pledged to consult with the FDA to work through any concerns with its submissions.

Pharmaxis (ASX:PSX) shares climbed 15% to $0.610 by 3:30 pm on Monday as the market reacted to the news.