SoftOx Solutions AS announced the end of the Phase 1 clinical study of the SoftOx Biofilm Eradicator (SBE-01) (EudraCT no. 2021-000314-42), SoftOx's antimicrobial solution for 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 the SoftOx Biofilm Eradicator (SBE) in patients with venous leg ulcers.

In Phase 1b the company treated the wounds once and twice daily over 5 days. The original study design included three times daily administration for five days; however, the company expects that data from the two first groups are sufficient to document safety, tolerability, and antimicrobial efficacy in clinically relevant treatment schedules in chronic wounds. SBE is in clinical development as an anti-infective treatment for chronic wounds, designed specifically to penetrate and kill pathogens within biofilms. Due to the broad spectrum and multi-targeted antimicrobial effects, SBE has been shown to kill antibiotic resistant bacteria in biofilms without inducing new antimicrobial resistance in vitro.

SoftOx has previously published clinical data supporting the association between reduced bacterial burden and improved wound healing. These associations will be further investigated in the planned SBE Phase 2 (SBE-02) study. As previously reported, SBE-01 recruitment was delayed in the early stages of the trial due to the Danish nursing strike in 2021.

To maintain overall clinical development timelines, SoftOx has taken the decision to omit the three times daily treatment, stop further patient recruitment and to end the trial.