SoftOx submits key clinical trial application for biological warfare countermeasure

SoftOx Solutions AS, through its fully owned subsidiary SoftOx Defense Solutions AS, has formally submitted a Phase 1 Clinical Trial Application (CTA) to the Irish Health Products Regulatory Authority (HPRA). This CTA is part of the European Defence Fund (EDF) program, which focuses on developing inhaled pharmaceuticals as medical countermeasures against biological warfare threats. This marks the second CTA delivered by the SoftOx group recently, underscoring the company’s clinical development progress.

The planned Phase 1 trial will assess the safety and tolerability of the SoftOx Inhalation Solution (SIS) at higher concentrations. The objective is to establish a broader therapeutic window for the solution, supporting its further clinical advancement as a medical countermeasure. Study commencement is anticipated in Q1 2026, contingent on regulatory approval.

Successful completion of this study and positive data are expected to reinforce SoftOx’s strategic position as a developer of dual-use technologies, addressing both civilian health needs and biological defense preparedness. This could also enhance its appeal as a potential partner for global pharmaceutical companies.