Following its strategic decision to initiate the first proof-of-concept (PoC) trial in people with cystic fibrosis, SoftOx announces published breakthrough data on the stability of hypochlorous acid (HOCl), the core component of its inhaled therapy (SIS).
The preformulation study, published in the Journal of Drug Delivery Science and Technology (Pham et al., 2025), demonstrates that storing HOCl as a solid precursor and generating it only when needed overcomes the long-standing stability barrier that has limited higher-strength HOCl formulations. The powder was highly stable for ≥24 months at ~23 °C when stored dry (≈≤5% degradation) and showed near-instant conversion on activation (≥99% within seconds).
CEO Thomas Bjarnsholt: “These findings validate the foundation of our inhaled SIS program. Combined with our focused clinical path in cystic fibrosis, they mark a pivotal moment for SoftOx.”
This breakthrough, based on the stability of the salt precursor, serves as the technological foundation for both the EDF Phase 1 study and the SIS Phase 2a study and represents the first step toward the next generation of SoftOx Inhalation Solutions (SIS) with extended shelf life for clinical use as well as for biological defense and terrorist countermeasure applications. The salt is also applied in the PoC trial in cystic fibrosis patients, where bacteria reside in biofilms that are less responsive to conventional antibiotics.
The upcoming PoC trial, planned for Q1 2026, will evaluate safety at higher doses in healthy volunteers and demonstrate bacterial load reduction in pwCF. Positive results would open the way to broader indications, including non-CF bronchiectasis (NCFB).
For more information, please contact:
Ulrik Spork, Chairman of the Board, SoftOx Solutions AS, +45 31 38 83 87
Thomas Bjarnsholt, CEO, SoftOx Solutions AS, +45 20 65 98 88
Mail: ir@soft-ox.com
About SoftOx Solutions AS:
SoftOx Solutions AS (ticker: SOFTX) is a clinical-stage pharmaceutical company listed on Euronext Growth Oslo. The company is developing highly effective pan-antimicrobial pharmaceuticals targeting bacteria, viruses, and fungi. The technology is based on extensive research and development in partnership with leading Nordic research institutes.
Reference: Pham AK, Hiorth M, Rongved P. A novel and stable formulation of powdered high-assay calcium hypochlorite as a solid precursor of the antimicrobial compound hypochlorous acid: a preformulation study. Journal of Drug Delivery Science and Technology 113 (2025) 107292. https://doi.org/10.1016/j.jddst.2025.107292