SoftOx Solutions AS (“SoftOx”) is pleased to announce that it has successfully manufactured and released its first Good Manufacturing Practice (GMP) batch of the SoftOx Inhalation Solution (SIS) Drug Substance, marking a significant step forward in the Company’s clinical and technological development.
The newly manufactured GMP-grade salt represents the core drug substance for the next generation of SoftOx products and will be used in both the upcoming Cystic Fibrosis (CF) Phase 2a trial and the European Defence Fund (EDF) Phase 1 trial.
This milestone demonstrates SoftOx’s ability to scale from research to GMP-compliant clinical manufacturing, ensuring quality, stability, and reproducibility in line with international pharmaceutical standards. The development also reinforces SoftOx’s role in creating medical countermeasures against biological threats under the EDF framework, combining healthcare innovation with defense preparedness.
Head of CMC Charlotte Pinholt comments:
“Having successfully manufactured and released the GMP drug substance, we are now finalizing preparations for GMP drug product manufacturing. This progress highlights the robustness of our CMC strategy and ensures that we can supply high-quality, reliable material for our upcoming clinical studies.”
CEO Thomas Bjarnsholt comments:
“The successful GMP manufacturing of our drug substance marks a significant milestone for SoftOx. It validates our technology’s maturity and readiness for clinical deployment in both healthcare and defense applications. This step also strengthens our foundation for future partnerships and commercialization opportunities.”
By achieving GMP manufacturing readiness, SoftOx significantly advances its position in the clinical pipeline, demonstrating operational capability, regulatory compliance, and increasing investor value as the company moves closer to trial execution and long-term product commercialization.
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.