SoftOx Solutions AS (“SoftOx”) is pleased to announce that its fully owned subsidiary SoftOx Defense Solutions AS has formally submitted its Phase 1 Clinical Trial Application (CTA) to the Irish Health Products Regulatory Authority (HPRA) for approval. The trial is part of the European Defense Fund (EDF) program, which aims to develop inhaled pharmaceuticals as medical countermeasures against biological warfare threats.
This submission represents the second CTA delivered by the SoftOx group within a short period, marking another important milestone in the Company’s clinical development strategy and execution capability.
The planned Phase 1 trial will evaluate the safety and tolerability of the SoftOx Inhalation Solution (SIS) at higher concentrations to establish a broader therapeutic window and support further clinical advancement as a medical countermeasure.
Study start is expected in Q1 2026, subject to approval.
Successful progress and positive data from this study are expected to further strengthen SoftOx’s strategic position as a developer of dual-use technologies — addressing both civilian health needs and biological defense preparedness — and enhance its attractiveness as a potential partner for global pharmaceutical companies.
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.