Pharmaxis (ASX:PXS) has formally completed the Phase 3 international trial assessing the effectiveness of Bronchitol in people with bronchiectasis.
The clinical trial which started in October 2009, was a double blind, controlled, randomised trial involving 485 participants and conducted across the US, Europe, South American and Australia.
The purpose of the trial was to examine the efficacy and safety of 52 weeks treatment with Bronchitol in subjects with non‐cystic fibrosis bronchiectasis.
Bronchitol has been developed to help remove inadequately cleared mucus (a major source of lung infections) and reduce exacerbations in patients with cystic fibrosis and bronchiectasis.
It is a proprietary formulation of mannitol administered as a dry powder in a hand‐held inhaler.
A positive outcome from the trial may form the basis for an extension to the existing marketing approvals for Bronchitol in the European Union and Australia where patients seeking treatment are estimated at 210,000 and 18,000 respectively.
The primary goal of the trial was to show a significant difference in the rates of graded pulmonary exacerbations, in patients with bronchiectasis treated with Bronchitol compared to control.
Secondary endpoints included quality of life; sputum weight and lung function as measured by spirometry.
Early results of the trial will be available during the second quarter of 2013.
About 600,000 people in the major pharmaceutical markets have bronchiectasis and no
products have been approved to assist with mucus clearance.
It ended the half-year ending December 2012 with $65 million in cash, and in late January it signed a financing agreement with NovaQuest Pharma under which NovaQuest will invest up to US$40 million to support the continued development, and commercialisation of Bronchitol in the EU and US.
The company's share prices at 54.5 cents has heavy cash backing of 34 cents per share, leaving significant room for upside.
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