SoftOx Solutions AS announced top line results from its Phase 1 clinical 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. In addition, the company provides an update on its financial situation.

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. Data from the SBE-01 study demonstrate that SBE was safe and well-tolerated.

There were no statistically significant differences in the evaluation of pain during and after the wound cleaning procedure comparing SBE with placebo. Treatment with all SBE formulations consistently reduced the absolute number of bacteria (bacterial burden) in the wound compared with pre-treatment (baseline). A dose dependent reduction in wound size was also observed in the multiple dose SBE treatment groups.

Proof of concept The SoftOx technology platform is highly versatile, new generation antimicrobial agent with the potential to treat different types of wounds, from infection prevention in acute surgical or non-surgical wounds to infection removal in wounds typically associated with biofilm such as chronic leg ulcers and traumatic penetrating injuries. SoftOx has previously published clinical data supporting the association between the use of SoftOx technology and improved wound healing in acute wounds. Taken together with the results from the SBE-01 study of antimicrobial effects in chronic leg wounds over a safe and tolerable dose range, these combined results are early proof of concept for the SoftOx wound care technology platform for a range of potential acute and chronic wound care indications.