Sydney-based pharmaceutical company Pharmaxis Ltd has conducted an interim analysis on the Phase IIb clinical trial evaluating Bronchitol™ in patients with the respiratory condition bronchiectasis.
The study is a Phase II blinded, controlled crossover study with a projected total enrolment of 60 patients to determine ’quality of life’ changes as a result of treatment with Bronchitol™. Secondary measures include exercise tolerance and sputum microbiology (a measure of lung infections). Based on the interim analysis of a group of 19 patients, the trend for all components of the quality of life assessment was positive. Compared to the inactive placebo, Bronchitol™ produced an improvement in the major component of quality of life of nine units (an improvement of four units is considered clinically relevant). The quality of life measurements used give a good indication of the benefits that patients would expect to achieve in everyday activities such as walking. No serious adverse events were reported.
This interim analysis provides the basis to complete enrolment of the remaining 41 patients and to prepare for the longer term Phase III studies. Pharmaxis Chief Executive Officer, Alan Robertson, said the results of the interim analysis are extremely encouraging, and exceeded expectations, having found statistical significance in relatively small patient numbers. “This is an important step in the development of Bronchitol™ and brings us closer to providing this important new medicine to patients whose lives are affected by bronchiectasis. “The successful completion of this leg of the study means we are now well positioned to progress with confidence the development and commercialisation of our clinical projects, as well as the scale up of our manufacturing capability,” Robertson said.