SoftOx Solutions AS announces that the Company has received the final report and analysis of its Phase 1 study evaluating the safety and tolerability of SoftOx Biofilm Eradicator (SBE-01) (EudraCT no. 2021-000314-42), SoftOx's antimicrobial solution for the treatment of chronic wounds. SBE-01 is a first-in-human study investigating the safety, tolerability, and antimicrobial efficacy of single and multiple doses of SBE in patients with chronic leg wounds.

The Phase 1 study was divided into two parts: a randomized, blinded, Single Ascending Dose (SAD) phase, followed by an open label, Multiple Ascending Dose (MAD) phase, where patients were treated once-daily or twice-daily over five days. Key findings The final report reaffirms previous findings that SBE is safe and well-tolerated by patients suffering from chronic leg wounds. There were no statistically significant differences in the evaluation of pain during and after the wound cleaning procedure comparing SBE with placebo.

The study found that formulations of SBE consistently reduced the bacterial burden in the wound compared with pre-treatment. There was also evidence of wound healing with a reduction in wound area of between 24 to 36% after just 5 days' treatment.