US-based biopharm Revagenix announced that it has initiated a Phase 1 trial of Rev-56, which it describes as an “inhaled, anti-pseudomonal therapy for non-cystic fibrosis bronchiectasis (NCFB).” The first part of the study will evaluate single doses of 5 strengths of nebulized Rev-56 versus placebo in healthy volunteers. The second part will enroll NCFB patients with P. aeruginosa lung infections who will receive nebulized Rev-56 or placebo once a day over 7 days.
The announcement notes that NIH’s National Institute of Allergy and Infectious Diseases (NIAID) has provided funding for development of Rev-56. According to the company’s web site, Revagenix is also developing a dry powder formulation of Rev-56 that is “intended to enhance patient convenience and expand the program’s reach.”
Revagenix CEO Ryan Cirz commented, “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. 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.”
Chief Operating Officer Andrew McCandlish added, “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. NIAID’s support has enabled advancement of a US-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.”
Read the Revagenix press release
