Zambon has presented results from its Phase 3 PROMIS-I study of CMS colistimethate sodium powder demonstrating that a CMS solution delivered via the Philips I-neb nebulizer significantly reduced exacerbations in patients with non-cystic fibrosis bronchiectasis (NCFB) and chronic P. aeruginosa lung infections. The company received Fast Track and QIDP designations for nebulized CMS for this indication in 2018.
The study enrolled 377 patients who received either CMS I-neb or placebo twice daily over 12 months. Patients who got CMS I-neb experienced an average of 0.58 exacerbations per year compared to 0.95 for patients who got the placebo. In addition, the CMS I-neb group had significant reductions in the density of P. aeruginosa after 28 days compared to the placebo group and also had a longer time to first exacerbation and reported better quality of life.
Zambon Chief Medical Officer and R&D Head Paola Castellani commented, “We would like to extend our sincere gratitude to all of the patients and study centers for their collaboration throughout PROMIS-I. We are delighted to see that the hard work and commitment from all parties has paid off and provided us with encouraging data. We hope that these data will prove to be an important step as we seek a much-needed treatment to manage NCFB.”
CEO Roberto Tascione said, “At Zambon, we are committed to developing treatments for severe respiratory diseases with limited treatment options. This trial is testament to our growing credibility in this area, representative of our drive for innovation and creates a strong foundation upon which we can continue to grow and provide needed medicines to improve patients’ lives. With a number of our other mid- and late-stage trials in respiratory diseases ongoing, we are encouraged by the positive data of PROMIS-I which we hope is the first of many successes.”
The company’s pipeline also includes L‑CsA‑i inhaled liposomal Cyclosporine A for the treatment of bronchiolitis obliterans syndrome (BOS), which received Fast Track designation from the FDA in 2020. Zambon acquired L‑CsA‑i when it acquired PARI Pharma spin off Breath Therapeutics in July 2019.
Read the Zambon press release.
