Australia’s Pharmaxis is moving closer to seeking approval for Bronchitol after the firm revealed that all of the patients on a late-stage study looking at the compound as a treatment for a chronic lung condition have completed the efficacy phase of the trial.
The 362-patient placebo-controlled Phase III trial of Bronchitol (mannitol) for bronchiectasis, an incurable, degenerative and chronic lung condition affecting more than half a million people in the western world alone, was conducted at 22 hospitals across Australia, New Zealand and the UK and is designed to evaluate the impact of the drug on mucus clearance, disease symptoms, cough severity, exercise capacity and lung function. The outcome from the trial will be available this quarter after the individual patient data has been checked, the study unblinded and the statistical analysis completed, Pharmaxis said.
The Sydney-headquartered firm noted that “there have been no new therapeutic advances for this patient group in the last 20 years” and it has the only product in Phase III for bronchiectasis anywhere in the world. The firm is understandably enthusiastic about the product as at least 110,000 patients in the USA are receiving treatment for the disease, and the medical care expenditure is over $630 million per year, so the market and an unmet medical need are there.
Also, Pharmaxis added that widespread availability of high-resolution scanners is leading to increases in diagnosis rates “and the understanding that bronchiectasis is more common than previously thought”. The Australian firm, which is also listed on the Nasdaq, has Phase III trials ongoing looking at Bronchiole as a treatment for cystic fibrosis and chronic bronchitis