Courier obtained FDA fast track qualification, innovative inhaled antibiotic therapy reached phase 3 clinical endpoint

▎ WuXi AppTec's content team editor recently, Zabon announced that it will use its I-neb adaptive inhalation aerosol drug delivery system to deliver myxomycete sodium (CMS) in non-cystic fibrosis bronchiectasis (NCFB) patients.
The primary endpoint was reached in the phase 3 clinical trial PROMIS-I
.

Compared with placebo, the annual incidence of acute exacerbations in NCFB patients in the CMS I-neb group was significantly reduced (0.
58 vs.
0.
95, RR: 0.
61, 95% CI 0.
46-0.
82, p=0.
00101)
.

Non-cystic fibrosis bronchiectasis (NCFB) is a chronic lung disease characterized by repeated infections, inflammations, persistent coughing and sputum production.
Its prevalence is increasing worldwide
.

Among NCFB patients, Pseudomonas aeruginosa (Pseudomonas aeruginosa) pulmonary infection is associated with frequent acute exacerbations of the disease and hospital admissions, reduced quality of life, and increased mortality
.

There is currently no approved treatment for the disease
.

CMS is a prodrug of the antibiotic colistin.
As a surfactant, it works by binding to the bacterial cell membrane and changing its permeability, causing bacterial death
.

I-neb is the third generation nebulizer for adaptive aerosol delivery (AAD)
.

It is a small, light and silent drug delivery device that can deliver accurate and repeatable drug doses
.

Image source: A total of 377 patients were enrolled in the 123RF trial, who were randomized to receive CMS I-neb (n=177) or placebo (n=200)
.

The results of the trial showed that in addition to the primary endpoint, the trial also reached important secondary endpoints.
Compared with placebo, the CMS I-neb group delayed the patient’s first acute exacerbation (HR=0.
59, 95% CI 0.
43- 0.
81, p=0.
00074); reduced the frequency of severe exacerbations (RR: 0.
41, 95% CI 0.
23-0.
74, p=0.
00300)
.

In addition, after 12 months of treatment, the quality of life measured by the St.
George's Respiratory Questionnaire (SGRQ) in the CMS I-neb group was significantly improved, with a difference of 4.
55 points compared with the placebo group (p=0.
0055)
.

After 28 days of treatment, the density of Pseudomonas aeruginosa in the treatment group was significantly reduced (P<0.
00001)
.

In terms of safety, the treatment system is well tolerated
.

The percentages of patients with adverse events were similar in the two groups
.

Bronchospasm and antibiotic resistance were rarely observed (2.
8% and 1%, respectively)
.

In addition, this therapy has obtained the US FDA Qualified Infectious Disease Product (QIDP) and Fast Track qualification to prevent the acute exacerbation of adult NCFB patients caused by Pseudomonas aeruginosa
.

"PROMIS-I data shows that taking CMS through I-neb twice a day can reduce the frequency of disease exacerbations in patients with bronchiectasis and chronic Pseudomonas aeruginosa infection, and improve the quality of life
.

" PROMIS-I principal researcher Dr.
Charles Haworth said, " The test data also proved that the system was well tolerated for 12 months
.

These results are encouraging for patients because there are currently no approved drug treatment options for this indication
.

"Reference: [1] Positive Results from Phase 3 PROMIS-I Study of CMS I-neb® in Patients with Non-Cystic Fibrosis Bronchiectasis Presented at European Respiratory Society (ERS) Annual Meeting.
Retrieved September 8, 2021, from https: // Disclaimer: WuXi content teams to focus progress of biomedical research on global health introduction
.

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in the
article .
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.

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.