Pharmaceutical company Pharmaxis announced that it has presented new data from its large scale study of Bronchitol, called B305, and conducted in patients with bronchiectasis, at the European Respiratory Society (ERS), which took take place from September 6th to 10th at the International Congress Center München in Munich, Germany.
The presentation, which was led by the Honorary Consultant Physician and Senior Lecturer in Respiratory Medicine at Newcastle University UK, Dr. Anthony de Soyza, was focused on a higher risk subgroup from the trial who managed to experience breathlessness, even though they received the best standard of care, were at rest, and yet still had frequent exacerbation.
The subgroup registered a high risk of further exacerbating, and Bronchitol was shown clinically relevant as it revealed significant improvements in exacerbation, antibiotic use, and total St George’s Respiratory Questionnaire (SGRQ) scores, a measurement instrument to assess overall health, daily life, and perceived well-being in patients with obstructive airways disease.
Researchers also demonstrated best standard of care over a 12 month period, which led to the conclusions that Bronchitol caused greater effects on higher risk patients than in the broader non-CF bronchiectasis patients. However, while the overall multi center study of Bronchitol in non-CF bronchiectatic patients, reported in April 2013, was not able to accomplish its primary purposes of an improvement in bronchiectasis exacerbation rate, the scientists believe that they made significant improvements in time to first exacerbation, SGRQ scores, and days of antibiotic use.
“Bronchiectasis continues to be a disease with very few treatment options and showing a clear treatment effect in such a heterogeneous patient population has proven difficult. The benefit shown in this subgroup of our B305 phase 3 study is therefore quite interesting. While Pharmaxis is not currently planning to progress the B305 data with another study, the authors of this new analysis noted that the positive findings should encourage further investigation,” stated Pharmaxis’ CEO, Gary Phillips.
Bronchiectasis is a chronic degenerative and incurable lung condition, which affects more than 600,000 people in the world. It is known to be a disease with high unmet medical needs, and patients suffer with an economic burden estimated at $1.45 billion in annual healthcare costs in the United States alone.
Other companies have also announced that they would present findings at the European conference. Insmed Incorporated was scheduled to announce its novel inhalation technologies for the treatment of orphan pulmonary diseases. Used for the treatment of rare lung infections in patients with limited alternatives,