According to SoftOx Solutions, the Danish Medicines Agency has approved the company’s application for a Phase 2a trial of SoftOx hypochlorous acid inhalation solution in healthy volunteers and in patients with cystic fibrosis. SoftOx announced in September 2025 that it would change the development focus of the inhalation solution from ventilator associated pneumonia to chronic lung disease.
In 2022, SoftOx announced results from a Phase 1 trial of the inhalation solution delivered via jet nebulizer. The company says that it expects to have topline data from the first part of the Phase 2a study in the first half of this year and data from the second part of the study in the first quarter of 2027.
SoftOx CEO Thomas Bjarnsholt commented, “Regulatory approval of our Phase 2a trial is a transformative step for SoftOx. This milestone substantially de-risks the program and gives us a clear, predictable path into human testing. The upcoming dose escalation readout in 1H 2026 and the PoC results expected in Q1 2027 are major catalysts for the company as we advance SIS toward later-stage development.”
Read the SoftOx press release
