SoftOx Solutions AS (SoftOx), a clinical-stage biopharmaceutical company based inNorway , announced today 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. "We would like to thank our study participants and the staff atDanTrials ApS . SoftOx is looking forward to announcing the top line results in Q4 2022," saidGlenn Gundersen , Sr Medical Director of SoftOx. 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. "With the closure of Phase 1 study, we can turn our attention towards analysing the data and complete our preparations for the Phase 2 study investigating the effect of SBE on wound closure in venous leg ulcers," said Gundersen. Co-funded by theUS Naval Medical Research Center The study is co-funded by theUS Naval Medical Research Center (NMRC) under theMedical Technology Enterprise Consortium (MTEC), a biomedical technology consortium that collaborates under a transaction agreement (OTA) with theUS Army Medical Research and Development Command. "The Phase 2 study will also be co-funded by theUnited States Naval Medical Research Center , and we are confident that the SBE-01 results will support selection of an optimal SBE formulation and dosing schedule for treating patients with chronic wounds in both hospital and long-term community care settings," said Gundersen. 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. Facts about biofilm:Biofilm in chronic wounds is a cluster of bacteria covered by a matrix, which makes it difficult for today's antibiotics to effectively eradicate the infection in chronic wounds. 1-2 % of the population are projected to experience a chronic wound during their lifetime in develop countries. Under the protection of biofilm, microbial cells in biofilm become tolerant and resistant to antibiotics and the immune responses, which increases the difficulties for the clinical treatment of biofilm infection. For further information, please contact: Geir Almås, CEO ofSoftOx Solutions AS , orGlenn Gundersen , Senior Medical Director ofSoftOx Solutions AS Mail: ir@soft-ox.com Phone: Front Desk: (+47) 948-59-599 AboutSoftOx Solutions AS SoftOx Solutions AS (SoftOx, listed on Euronext Growth Oslo) is a Norwegian BioTech company based inOslo with the aim of helping to combat major threats to human health, namely the emergence of antimicrobial resistance (AMR), biofilm infections in chronic wounds and the spread of viruses. For more information on SoftOx, visit www.soft-ox.com
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