According to SoftOx Solutions, the company intends to conduct a Phase 1 proof-of-concept dose escalation study of SoftOx inhalation solution (SIS) in cystic fibrosis patients as part of a refocus away from development of SIS for the treatment of ventilator associated pneumonia. The company says, “The chronic lung disease indication offers a tangible and feasible development path, and positive outcomes will demonstrate the ability of SoftOx’s technology to broadly eradicate bacteria in lung infections.”
SoftOx has been developing the hypochlorous acid inhalation solution for VAP and as a military countermeasure. In 2023, the company announced that it was closing its own research facility and outsourcing development of SIS to the University of Copenhagen.
The company says that it expects to submit an application for the new clinical trial by the end of this month and plans to initiate the 12-month study in the first quarter of 2026. The first part of the trial will evaluate SIS first in healthy volunteers and the second part will enroll CF patients with chronic lung infections.
SoftOx CEO Thomas Bjarnsholt commented, “The patients we are targeting for the PoC study live with infections and attend hospitals frequently for treatment. While there are differences amongst them, they form a relatively homogeneous group accessible through established networks. They are familiar with hospitalization, can reliably convey potential adverse events, treatment effects, and provide test samples, directly linked to trial endpoints. These traits are pivotal for generating convincing PoC results within viable timelines, and the revised setup of this initial patient trial allows us to document a larger dosing headroom than would have been possible in VAP.”
Chairman of the Board Ulrik Spork commented, ”Due to the unique mode of action of SIS, SoftOx believes it may be applied effectively in several pulmonary indications. Therefore, the stronger and broader applicable PoC foundation we can generate, the better. Consequently, proving the platform in CF and expanding the therapeutic window makes compelling sense both scientifically and commercially. Although orphan, CF is a highly relevant, tangible, and commercially attractive opportunity, but equally important, results here will directly enable us to pursue NCFB, and the PoC safety and efficacy data will document the broader applicability of SIS as an inhaled pan-microbial pharmaceutical in both chronic and acute settings. We truly believe this new approach to reducing pulmonary infections has the potential to positively impact the lives of thousands of patients and their families.”
Read the SoftOx Solutions press release
