The Problem: Chronic Infections remain difficult to treat
CF illustrates the core challenge of chronic respiratory infections: persistent bacterial colonization and biofilm formation that render antibiotics ineffective – challenges equally seen in bronchiectasis. Despite advances with CFTR modulators, people with CF still require lifelong antimicrobial therapy. Still, they are not adequately helped by traditional antibiotics, which fail to eradicate biofilms, fuel resistance, and fall short of long-term treatment needs.
The Opportunity: Proof-of-concept in CF
SIS represents a new therapeutic principle by targeting tolerant bacteria in biofilms without inducing resistance. In CF, ~13,000 patients in the US and EU4+UK receive chronic inhaled antibiotic therapy, representing an annual market of >$600M, and provides a direct segway to substantially larger indications and market value in other airway diseases such as non-CF bronchiectasis (NCFB). A pivotal Phase IIa CF trial – with topline results expected in Q2 2027 – represents a near-term market validation and a major value inflection point for SoftOx, while confirming the safety, efficacy, and clinical applicability of SIS’s patented mode of action.
The Execution: Phase IIa – validating approach and unlocking significant market potential
Conducted with Rigshospitalet’s world-leading CF center, the trial combines dose escalation in healthy volunteers with an efficacy arm in 15–25 CF patients. The primary endpoint is a ≥ 2 log10 reduction in bacterial load in sputum – a clinically meaningful outcome validating SIS’s antimicrobial profile. Positive data will drive regulatory progression and unlock strategic partnering opportunities.
The Potential: Beyond CF
CF serves as the strategic entry point, but the impact of SIS reaches far beyond. By overcoming biofilms, tolerance, and resistance, SIS has the potential to transform respiratory infection treatment globally. The natural next step is expansion into NCFB, affecting ~1.1 million patients across the US, EU4, and UK, of which ~445,000 form the treatable population – a multi-billion USD annual market. Beyond CF and NCFB, SIS holds promise across a wide spectrum of respiratory infections, including viral and fungal pneumonias – underscoring SIS’s potential as the first truly pan-antimicrobial inhalation therapy.
How it works
SIS is an aqueous, isotonic formulation of hypochlorous acid, stabilized for aerosolization and suitable for administration to the respiratory tract using a standard nebulizer. SoftOx hypothesizes that SIS inactivates and kills intracellular and extracellular bacteria and viruses in the upper and lower respiratory tract, resulting in a reduction in bacterial/viral load, thereby improving symptoms, shortening disease duration, and preventing onward disease transmission. Such a drug would be ideal in the efforts to limit the health and societal impact of Influenza, SARS-CoV-2, etc., and future pandemics as well as for patients suffering from chronic airway infections and Ventilator Associated Pneumonia (VAP).
