MediWound Announces Positive Results in U.S. Phase I/II Study of MW005 for the Treatment of Basal Cell Carcinoma
MW005 shown to be safe and well-tolerated
Data provides clinical efficacy proof-of-concept based on complete clearance of target lesions
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
“Most low-risk BCCs are treated surgically. There is a clear unmet need for an effective, non-surgical, topically-applied, short duration treatment for low-risk BCC with less severe local skin reactions associated with current topical therapies,” said Dr.
BCC is a non-melanoma skin cancer that arises from the basal layer of epidermis and its appendages. According to the
NexoBrid, our commercial orphan biological product for non-surgical eschar removal of deep-partial and full-thickness thermal burns, is a bromelain-based biological product containing a sterile mixture of proteolytic enzymes that selectively removes burn eschar within four hours without harming surrounding viable tissue. NexoBrid is currently marketed in the
EscharEx, based on the same active pharmaceutical ingredient as NexoBrid, is our next-generation bioactive topical therapeutic under development for the debridement of chronic and hard-to-heal wounds. Results from Phase 2 studies show that EscharEx is significantly more effective and faster than SOC or placebo control in debridement of VLUs and DFUs, with a good safety and tolerability profile.
MW005 is our topical biological drug under development for the treatment of low-risk Basal Cell Carcinoma (BCC). Its proprietary formulation is designed for safe and easy self-administration. It contains the same active pharmaceutical ingredient as NexoBrid and EscharEx. In a Phase I/II open-label, multicenter, randomized clinical trial conducted in the
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MediWound cautions you that all statements other than statements of historical fact included in this press release that address activities, events, or developments that we expect, believe, or anticipate will or may occur in the future are forward-looking statements. Although we believe that we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting us and are subject to risks, assumptions, uncertainties, and factors, all of which are difficult to predict and many of which are beyond our control. Actual results may differ materially from those expressed or implied by the forward-looking statements in this press release. These statements are often, but are not always, made through the use of words or phrases such as “anticipates,” “intends,” “estimates,” “plans,” “expects,” “continues,” “believe,” “guidance,” “outlook,” “target,” “future,” “potential,” “goals” and similar words or phrases, or future or conditional verbs such as “will,” “would,” “should,” “could,” “may,” or similar expressions.
Specifically, this press release contains forward-looking statements concerning the anticipated progress, development, study design, expected data timing, objectives anticipated timelines, expectations and commercial potential of our products and product candidates, including MW005. Among the factors that may cause results to be materially different from those stated herein are the inherent uncertainties associated with the uncertain, lengthy and expensive nature of the product development process; the timing and conduct of our studies of our products and product candidates, including the timing, progress and results of current and future clinical studies, and our research and development programs; the approval of regulatory submission by the FDA, the
These and other significant factors are discussed in greater detail in MediWound’s annual report on Form 20-F for the year ended December 31, 2021, filed with the Securities and Exchange Commission (“SEC”) on March 17, 2022, quarterly Reports of Foreign Private Issuer on Form 6-K and other filings with the SEC from time-to-time. These forward-looking statements reflect MediWound’s current views as of the date hereof and MediWound undertakes, and specifically disclaims, any obligation to update any of these forward-looking statements to reflect a change in their respective views or events or circumstances that occur after the date of this release except as required by law.
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Source: MediWound Ltd.