SoftOx Defense Solutions AS, a subsidiary of clinical-stage pharmaceutical company SoftOx Solutions AS (Euronext Growth Oslo:SOFTX), announced on Wednesday that Ireland's Health Products Regulatory Authority has approved its clinical trial application for the SIS-02 Phase 1 study in healthy volunteers.

The trial will assess safety, tolerability, and pulmonary exposure of SoftOx's inhaled SIS solution, marking the transition into controlled human testing and establishing foundational dosing data for civilian and preparedness-oriented pathways.

Irish approval gives SoftOx two active regulatory-cleared trials, alongside a Phase 2a cystic fibrosis study approved by the Danish Medicines Agency. This enables parallel execution across Phase 1 safety and exposure work in Ireland and Phase 2a dose escalation and early proof-of-concept in Denmark, supporting simultaneous clinical development and preparedness-related development activities.

SoftOx's SIS platform is being developed as a broad-spectrum, non-antibiotic inhaled therapeutic with activity against bacteria, viruses, and fungi. It offers localised airway delivery and low risk of resistance development. The company states that scalable manufacturing and formulation stability could support stockpiling and rapid deployment frameworks, contingent on clinical validation and strategic or non-dilutive funding.