Oslo / Dublin: SoftOx Defense Solutions AS (“SoftOx”) announces that the Health Products Regulatory Authority (HPRA) in Ireland has approved the Company’s clinical trial application (CTA) for the SIS-02 Phase 1 clinical study in healthy volunteers.
The SIS-02 study will evaluate the safety, tolerability, and pulmonary exposure profile of SoftOx’s inhalation solution. The approval represents a critical execution milestone, transitioning SIS into controlled human testing and establishing the human safety and dosing foundation required for both civilian development and preparedness-oriented pathways, including defence and biological countermeasure applications.
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Strategic and Scientific Significance
Approval of SIS-02 confirms the readiness of SoftOx’s inhalation platform for human clinical evaluation and validates the Company’s development capabilities across GMP manufacturing, regulatory documentation, and clinical execution.
Conducting SIS-02 enables SoftOx to:
Establish robust human safety and tolerability data
Characterize pulmonary dose and exposure
Generate foundational human data required for emergency-use and preparedness-relevant development routes
Business Implications: Parallel Clinical and Preparedness Execution
With the approval of SIS-02, SoftOx now has two regulatory-approved clinical trials, following the previously announced Phase 2a approval by the Danish Medicines Agency.
This positions the Company to move from sequential development into parallel execution, including:
Phase 1 human safety and exposure (Ireland)
Phase 2a dose escalation and early proof-of-concept in cystic fibrosis (Denmark)
The establishment of human safety and dosing data across these programs also enables SoftOx to consider programs for Dual-use and preparedness-oriented development activities in parallel with clinical execution.
Value and Relevance for Dual-Use and Biodefence Preparedness
SoftOx’s SIS platform is being developed as a broad-spectrum, non-antibiotic inhaled therapeutic with attributes relevant to modern biodefence and medical countermeasure strategies, including:
Activity against bacteria, viruses, and fungi addressing diverse airborne biological threats
Low risk of resistance development, preserving long-term effectiveness and deployment flexibility
Local airway administration enabling rapid onset at the primary site of exposure
Scalable manufacturing and formulation stability are potentially compatible with stockpiling and rapid deployment frameworks
These attributes create potential optionality for future preparedness-oriented development pathways, contingent upon clinical validation and strategic or non-dilutive funding support.
If pursued, this would enable the SIS platform to address both chronic respiratory disease and defence-relevant biological threats within national resilience and pandemic response architectures.
While the dual-use profile thus enhances the long-term commercial flexibility of the platform, it does not alter the current clinical development focus, nor jeopardize the financial discipline applied in execution.
CEO, Thomas Bjarnsholt, comments:
“The approval of SIS-02 by HPRA in Ireland is a key execution milestone for SoftOx. It establishes the human safety and dosing foundation of our inhalation platform and, together with our already approved Phase 2a program, enables us to advance civilian development while progressing preparedness-oriented and defence-relevant applications in parallel.”
Next step
Following approval, SoftOx will proceed with clinical site initiation and dosing of healthy volunteers in accordance with the approved protocol.
For further 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 develops innovative, non-antibiotic antimicrobial inhalation therapies targeting bacteria, viruses, and fungi, with applications spanning civilian healthcare, public health preparedness, and future biological countermeasures.
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