Revagenix Doses First Participant in Phase 1 Trial of Rev-56, a First-in-Class Inhaled Anti-Pseudomonal Therapy for Non-CF Bronchiectasis
Key Insights
Revagenix (search) has dosed the first participant in its Phase 1 clinical trial of Rev-56 (search), an inhaled, first-in-class anti-pseudomonal therapy for non-cystic fibrosis bronchiectasis (search) (NCFB).
Rev-56 (search) targets chronic Pseudomonas aeruginosa, a key driver of exacerbations, hospitalizations, disease progression, and mortality in NCFB, for which no FDA-approved therapies currently exist.
Part A of the study will evaluate safety, tolerability, and pharmacokinetics in healthy volunteers, with topline data expected by year-end 2026.
Revagenix (search), Inc. announced today that the first participant has been dosed in the Phase 1 clinical trial of Rev-56 (search), a first-in-class, inhaled, anti-pseudomonal therapy for non-cystic fibrosis bronchiectasis (search) (NCFB). The milestone marks a significant step toward addressing a high-risk patient population that currently has no FDA-approved therapies specifically indicated for chronic Pseudomonas aeruginosa infection.
Rev-56 (search) targets chronic P. aeruginosa, which the company identifies as a key driver of increased exacerbations, hospitalizations, disease progression, and mortality in NCFB. The disease is a serious, progressive respiratory condition affecting an estimated 350,000 to 500,000 adults in the United States, with millions more affected worldwide.
"Dosing our first participant is a defining milestone for Revagenix (search) and, more importantly, a step toward a targeted treatment option for people living with NCFB," said Ryan Cirz, PhD, Chief Executive Officer of Revagenix. "Rev-56 (search) was purpose-built for NCFB, a chronic, progressive disease where high compliance is essential. We started with a long-term vision for the patient experience and worked backwards to the science — an optimized inhaled delivery with a novel mechanism of action, designed to support consistent use and, in turn, deliver maximum impact."
Trial Design and Timeline
The Phase 1 study (NCT07709494) is divided into two parts. Part A will evaluate the safety, tolerability, and pharmacokinetics of inhaled, nebulized Rev-56 (search) in healthy volunteers. Topline data from Part A are expected by year-end 2026. Part B will extend the evaluation to NCFB patients with confirmed P. aeruginosa infection, assessing the same safety and pharmacokinetic parameters alongside initial pharmacodynamic metrics.
Rev-56 (search) was engineered with optimized physical properties for convenient inhalation delivery and works through a novel mechanism of action, with the potential for once-daily dosing — a feature designed to support long-term compliance in a chronic disease setting.
Unmet Need in NCFB
NCFB is characterized by recurrent infection and exacerbations, frequent hospitalizations, and a steady decline in lung function and quality of life. Chronic infection with P. aeruginosa is associated with the most severe disease trajectory, including higher rates of exacerbation, disease progression, and mortality.
"Bronchiectasis patients with chronic Pseudomonas aeruginosa infection suffer from higher rates of exacerbation and hospitalization and greater disease severity; however, there remains no FDA approved therapies specifically indicated for this high-risk, very sick population," said Dr. George M. Solomon, Associate Professor and Director of the Bronchiectasis and NTM program at the University of Alabama, Birmingham. "A targeted anti-pseudomonal therapy optimized for delivery to the lung offers a promising approach to managing these challenging chronic P. aeruginosa infections and improving clinical outcomes for patients."
Development Support
The development of Rev-56 (search) has been supported by the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health, under Contract No. 75N93022C00061. This federal backing helped bridge the program from discovery through early clinical development.
"NIAID backed Rev-56 (search) when a solid product vision was in place, but the science was still too early to attract significant private investment," said Andrew McCandlish, PhD, COO of Revagenix (search). "That support, alongside the expertise of the therapeutics development scientists at NIAID, is a big reason the program is in the clinic today."
Revagenix (search), launched in 2020 and backed by Novo Holdings and Tenmile, focuses on developing targeted, purpose-built medicines for serious chronic diseases with an initial emphasis on respiratory disease.