— Potential first therapy to target chronic Pseudomonas aeruginosa in non-cystic fibrosis bronchiectasis
— Chronic Pseudomonas is a key driver of inflammation, exacerbations, and disease progression in bronchiectasis
— Topline Phase 1 data expected by year-end 2026
SAN FRANCISCO, July 27, 2026 (GLOBE NEWSWIRE) -- Revagenix, Inc., a biopharmaceutical company developing targeted, purpose-built medicines for serious chronic diseases, today announced that the first participant has been dosed in the Phase 1 clinical trial of Rev-56, a first-in-class, inhaled, anti-pseudomonal therapy for non-cystic fibrosis bronchiectasis (NCFB).
Rev-56 targets a key driver of increased exacerbations, hospitalizations, disease progression and mortality in NCFB — chronic Pseudomonas aeruginosa. NCFB is a serious, progressive respiratory disease affecting an estimated 350,000 to 500,000 adults in the United States—and millions more worldwide. Rev-56 was engineered with optimized physical properties to be delivered via convenient inhalation, works through a novel mechanism of action, and has the potential for once-daily dosing.
“Dosing our first participant is a defining milestone for Revagenix 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 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. We look forward to sharing topline data from Part A of this study later in 2026.”
About the Phase 1 trial
Part A of the study evaluates the safety, tolerability, and pharmacokinetics of inhaled (nebulized) Rev-56 in healthy volunteers. Topline data for Part A are expected by year-end 2026. Part B of the study will evaluate those same parameters, as well as initial pharmacodynamic metrics in NCFB patients with P. aeruginosa. The study is registered on ClinicalTrials.gov (NCT07709494). The development of Rev-56 has been supported by the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health, whose backing helped bridge the program from discovery through early clinical development.
“NIAID backed Rev-56 when a solid product vision was in place, but the science was still too early to attract significant private investment. That support, alongside the expertise of the therapeutics development scientists at NIAID, is a big reason the program is in the clinic today,” said Andrew McCandlish, PhD, COO of Revagenix. “NIAID’s support has enabled advancement of a U.S.-produced, first-in-class product candidate with the potential to improve the lives of NCFB patients who have limited treatment options, including reducing hospitalizations with the associated burden to the patient and the healthcare system.”
About Non-Cystic Fibrosis Bronchiectasis (NCFB)
NCFB is marked 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. There are currently no therapies indicated to address P. aeruginosa in patients with NCFB.
“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 and Director of Clinical Research for the Gregory Fleming James CF Research Center 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. I look forward to seeing the Phase 1 data.”
About Revagenix
Revagenix is a biopharmaceutical company developing targeted, purpose-built medicines for serious chronic diseases — with an initial focus on respiratory disease. Launched in 2020 and backed by Novo Holdings, Tenmile, and supported by the U.S. National Institutes of Health, Revagenix designs each candidate with the real-world patient experience front of mind. Its lead program, Rev-56, is in Phase 1 development for non-cystic fibrosis bronchiectasis. Learn more at revagenix.com.
This project has been funded in whole or in part with Federal funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Contract No. 75N93022C00061. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Reference (US prevalence): Weycker D, Hansen GL, Seifer FD. Prevalence and incidence of noncystic fibrosis bronchiectasis among US adults in 2013. Chron Respir Dis. 2017;14(4):377–384.
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