MediWound says MW005 shown to be safe, well-tolerated in Phase I/II study

MediWound announced data from its Phase I/II study to evaluate the safety and efficacy of MW005 in the treatment of low-risk Basal Cell Carcinoma. The data shows MW005 to be safe and well-tolerated, with patients achieving complete clinical and histological clearance of their target lesions. MW005 contains the same active pharmaceutical ingredient as in NexoBrid and EscharEx. The results of this study represent further demonstration of the efficacy of MediWound’s core enzymatic platform technology across various indications. Based on these positive results, MediWound plans to continue enrolling patients in its Phase I/II study, optimizing its dosing regimen and application technique. The results are expected in 2023. The Phase I/II study is an open-label, multicenter, randomized clinical trial designed to evaluate the safety and efficacy of MW005 in patients with BCC, using different regimens. All patients enrolled in the study must have histologically confirmed superficial or nodular BCC. Enrolled patients receive seven topical applications of MW005 once every other day for 14 days. Eight weeks after the last treatment, all patients undergo a complete excisional biopsy, and the specimen is subject to an independent histological clearance examination. The study’s endpoints include safety and tolerability measurements, as well as efficacy assessment, as measured by the proportion of patients who reach clinically and histologically confirmed complete clearance. Eleven patients with either superficial or nodular histologically diagnosed BCC lesions were treated and completed the study. Based on the data generated, MW005 was shown to be safe, well-tolerated, and an effective treatment for BCC with patients demonstrating complete clinical and histological clearance of target lesions. These results corroborate with previous POC IIT study published by Prof. Rosenberg et al (Basal Cell Carcinoma Destruction by a Concentrate of Proteolytic Enzymes Enriched in Bromelain: A Preliminary Report; TODJ-15-39, 2021), where seven BCC tumors treated with MW005 were completely removed based on clinical assessment, and none reoccurred over the subsequent 18 months.