SoftOx Solutions AS announced top line results from its Phase 1 study evaluating SoftOx Inhalation Solution (SIS). SIS is a novel aqueous formulation of hypochlorous acid (HOCl), a biological oxidant with broad spectrum antimicrobial (antiviral and antibacterial) properties. In this Phase 1, first-in-human study, nebulised SIS achieved the primary objective of safety and tolerability in healthy subjects.

There were no observed local tolerability issues, no adverse effects on pulmonary function, and no serious adverse events. SIS-01 is a first-in-human study investigating the safety and tolerability of single and multiple ascending doses of nebulised SIS to healthy subjects. The randomized, double-blind trial was the first systematic, placebo-controlled study investigating the safety and tolerability of inhaled HOCl in humans.

A total of 57 healthy volunteers were randomised to receive SIS formulations of up to 100 µg/ml HOCl, four times daily for five days, or a matching placebo regimen. Data from the study demonstrates that an aqueous formulation of HOCl can be administered to the respiratory tract as an aerosol, as evidenced by dose-response effects on safety parameters, which were predominantly mild, even in the most intensive dosing regimen. With these positive results from the Phase 1 study, SoftOx will continue Phase 2 clinical development of SIS.

The company is already in the process of preparing Phase 2 documentation and is engaged in dialogue with the European Medical Association.