SAN FRANCISCO, Calif., July 27, 2026
Revagenix, Inc. announced that the first participant has been dosed in the Phase 1 clinical trial evaluating Rev-56, a first-in-class inhaled therapy being developed for non-cystic fibrosis bronchiectasis (NCFB). The investigational treatment is designed to specifically target chronic Pseudomonas aeruginosa infections, a major cause of disease progression, frequent exacerbations, hospitalizations, and increased mortality in patients with NCFB. According to the company, Rev-56 has been engineered for once-daily inhalation, combining optimized delivery directly to the lungs with a novel mechanism of action intended to improve treatment adherence and clinical outcomes. The milestone marks the transition of Rev-56 into human clinical testing, with topline data from Part A of the Phase 1 study expected by the end of 2026.
Phase 1 Study Evaluates Safety and Pharmacokinetics
The Phase 1 trial is divided into two parts to evaluate the safety profile of Rev-56 before advancing into patients with bronchiectasis. Part A is enrolling healthy volunteers to assess the therapy’s safety, tolerability, and pharmacokinetics following inhaled administration using a nebulizer. Following completion of this portion, Part B will evaluate the same safety and pharmacokinetic parameters while also examining initial pharmacodynamic measurements in NCFB patients with chronic Pseudomonas aeruginosa infection. The study has been registered on ClinicalTrials.gov and is supported by the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH), which has provided funding and scientific support from early discovery through clinical development.
Targeting a Significant Unmet Need in Bronchiectasis
Non-cystic fibrosis bronchiectasis is a progressive respiratory disease affecting an estimated 350,000 to 500,000 adults in the United States and millions more globally. Patients with chronic Pseudomonas aeruginosa infection experience more frequent disease flare-ups, accelerated decline in lung function, higher hospitalization rates, and increased mortality compared with other patients. Despite the significant clinical burden, there are currently no FDA-approved therapies specifically indicated to treat chronic Pseudomonas aeruginosa infections in NCFB. Revagenix Chief Executive Officer Ryan Cirz, Ph.D., said the company designed Rev-56 specifically for long-term management of bronchiectasis, focusing on convenient inhaled delivery and patient adherence. Clinical expert Dr. George M. Solomon of the University of Alabama at Birmingham noted that a targeted anti-pseudomonal therapy optimized for lung delivery could represent an important advancement for patients with limited treatment options.
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Revagenix Expands Respiratory Disease Pipeline
The advancement of Rev-56 into Phase 1 clinical development represents a significant milestone for Revagenix, a biotechnology company focused on developing targeted therapies for serious chronic respiratory diseases. Founded in 2020, the company is backed by Novo Holdings and Tenmile, with additional support from the National Institutes of Health through NIAID funding. Revagenix stated that federal support played a key role in advancing the investigational therapy from laboratory discovery into clinical testing. If successful, Rev-56 has the potential to become the first therapy specifically developed to address chronic Pseudomonas aeruginosa infection in non-cystic fibrosis bronchiectasis, offering a new treatment option that could reduce exacerbations, lower hospitalization rates, preserve lung function, and improve long-term quality of life for patients living with this chronic respiratory disease.
Source: Revagenix press release
