Hope for non-cystic fibrosis bronchiectasis patients following positive Phase III results
pharmafile | September 9, 2021 | News story | |
Pharmaceutical company Zambon has announced positive results from the Phase III PROMIS-I study, which examined the use of colistimethate sodium powder for patients with non-cystic fibrosis bronchiectasis (NCFB).
NCFB is a chronic lung disease characterised by recurrent infection, inflammation, and a persistent cough. The prevalence of NCFB varies among populations, and the incidence of NCFB also appears to be rising in females as well as older individuals.
The CMS powder was delivered by the I-neb AAD system for the prevention of pulmonary exacerbations for patients, and the data from the study showed that CMS I-neb significantly reduced the annual rate of exacerbations in patients with NCFB who are chronically infected with P. aeruginosa.
The PROMIS-I randomised, controlled trial met its primary endpoint, demonstrating that use of CMS I-neb twice-daily significantly reduced pulmonary exacerbations over the course of the 12-month study. The trial also met its secondary endpoints, one of which showed that CMS I-neb also delayed the time of first exacerbation compared to placebo. Quality of life also drastically improved in the CMS I-neb arm, with 4.55 point difference vs placebo after 12 months of treatment.
Zambon, in collaboration with its long-standing partner Xellia, are currently working towards making the CMS I-neb drug approved across the globe. The positive data PROMIS-I marks a crucial step in developing treatments for severe respiratory diseases with limited treatment options.
Charles Haworth, Respiratory Physician at the Cambridge Centre for Lung Infection at Royal Papworth Hospital, and PROMIS-I Chief Investigator, says: “The data demonstrate that 12 months treatment is well tolerated. These results are encouraging for patients as there is currently no approved drug treatment for this indication.”
Lina Adams
