SoftOx Solutions AS (SoftOx) announced that the last patient has completed the last single-dose cohort of the SBE-01 clinical study. This marks the end of the first part (SAD phase 1a) of SBE-01 (EudraCT no. 2021-000314-42).

The Safety Monitoring Committee (SMC) has now recommended the study to continue to enter the last phase (MAD** phase 1b) based on encouraging safety and antimicrobial effect measures. In this part of the SBE-01 study company will test the recommended SBE-product once or multiple times daily over 5 days. This will further document the safety, tolerability, and antimicrobial efficacy when SBE is administered on a more intense and clinically relevant treatment schedule.

The phase 1b will establish a tolerable dose and treatment schedule for SBE to be able to develop it into an effective infection-treatment solution in problematic, non-healing wounds. SBE-01 is the first-in-human (phase 1) study with the SoftOx's lead wound care product, SBE (SoftOx Biofilm Eradicator), designed to treat infected chronic wounds. Chronic wounds represent a silent epidemic with an estimated 40 million chronic wounds worldwide and two million related amputations annually.

As these wounds last on average 12/13 months and recur in up to 70% of patients, they can lead to loss of function and decreased quality of life as well as are a significant cause of morbidity. SoftOx is currently exploring different indications such as venous leg ulcers and diabetic foot ulcers with the aim to improve the treatment and quality of life for these patients.