The U.S. Food and Drug Administration (FDA) granted Qualified Infectious Diseases Product (QIDP) and Fast Track designations to Zambon’s inhalable colistimethate sodium product to help prevent non-cystic fibrosis bronchiectasis (NCFBE) from worsening because of Pseudomonas aeruginosa infection.
QIDP designation is given to antibacterial and antifungal products being developed for the treatment of serious or life-threatening infections. Together with the Fast Track designation, these new regulatory statuses are expected to support the clinical development and regulatory review of Zambon’s colistimethate sodium powder solution.
Colistimethate sodium is an antibiotic that can fight gram-negative bacteria, such as P. aeruginosa.
Zambon has developed the medication to be used with the I-Neb AAD system that was developed in collaboration with Philips. The I-Neb AAD system was designed to deliver nebulized medications directly into the lungs via inhalation. This makes it possible to minimize the risk of systemic exposure and the potential side effects of antibiotics.
The solution is being tested as a treatment for NCFBE patients with chronic lung infections in two Phase 3 clinical trials. The trials are being conducted in collaboration with Xellia Pharmaceuticals, which will provide the active agent for the treatment.
“With our Phase 3 trial on NCFBE, we are among the very few companies committed to continue to develop a treatment against this disease with the aim of offering new prospects to the patients with the seriously disabling disease NCFBE,” Roberto Tascione, CEO of Zambon, said in a press release.
PROMIS-1 trial (NCT03093974) is being conducted at approximately 50 sites in Europe, Israel, Australia, and New Zealand, and PROMIS-2 trial (NCT03460704) is being carried out in Europe, North and South America.
The two studies, which are recruiting, are expected to enroll 840 adult patients who will be randomized to receive either colistimethate sodium or a placebo.
Researchers will evaluate the capacity of the treatment to reduce acute pulmonary exacerbations, reduce pulmonary bacterial burden, and improve patients’ quality of life.
“In recent years, Zambon has met major goals, which allow us to continue to pursue our mission to innovate cures and therapies aimed at improving the quality of life for patients worldwide,” Tascione said.
Zambon plans to request approval of the inhalable colistimethate sodium in the second half of 2021.
NCFBE is a chronic, irreversible disease characterized by dilated, scarred, and inflamed airways that accumulate thick mucus, making gas exchange more difficult. With the buildup of mucus in the airways, patients become more susceptible to lung infections. Recurrence of such infections further exacerbates the disease symptoms, and progressively reduces the patient’s respiratory capacity.