Benzinga | Jan 11, 2021 07:13AM EST

MediWound Announces Phase 2 Adaptive Design Study Sample Size Reduced to 120 Patients; Interim Assessment Expected in Mid-2021 and Completion of Enrollment by Year-End 2021

MediWound Ltd. (NASDAQ:MDWD), a fully integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today provided an update on its EscharEx(r) clinical development program.

Due to COVID-19 related enrollment delays and potentially future pandemic related implications on the conduct of its clinical studies, the company is accelerating its EscharEx phase 2 adaptive design study, for the treatment of venous leg ulcers (VLUs), by adjusting its enrollment target to 120 patients, down from the 174 originally planned. The sample size adjustment is supported by the assessment of the positive results generated in a recent in-vivo study, comparing EscharEx to a commercially enzymatic debriding agent, and the debridement efficacy results demonstrated in a previous phase 2 clinical study with first generation EscharEx. The company continues to actively recruit patients and reiterates its expectation for an interim assessment in mid-2021. As a result of the adjustment, study duration is expected to shorten and the company anticipates completing patient enrollment by year-end 2021.

MediWound recently submitted a protocol to the FDA for a pharmacology study and is preparing to initiate this study in the first half of 2021. The study is an open label, single arm study assessing the pharmacological effects of EscharEx in up to 15 patients with VLUs or diabetic foot ulcers (DFUs), including the effects on biofilm burden and wound inflammation, as well as the impact of EscharEx on wound healing progression. The company anticipates reporting data from this study in the second half of 2021.

"We are very pleased with the progress we have made in our EscharEx development program in 2020, despite the challenges posed by the COVID-19 pandemic," said Sharon Malka, Chief Executive Officer of MediWound. "Chronic wounds present a significant unmet medical need for many patients, and we believe that EscharEx can have a meaningful impact on chronic wound management, offering significant benefits for patients, healthcare professionals and payers. We welcome 2021 with great anticipation and look forward to the pharmacology study data as well as the interim assessment and completion of patient enrollment in our phase 2 adaptive design study."