MediWound Announces Positive Initial Data from its U.S. Phase I/II Study of MW005 for the Treatment of Basal Cell Carcinoma
- Category: Proteins and Peptides
- Published on Tuesday, 12 July 2022 10:09
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MW005 Shown to Be Safe and Well-Tolerated
Target Lesions Clearance Data Provides Clinical Efficacy Proof-of-Concept
YAVNE, Israel I July 11, 2022 I MediWound Ltd. (Nasdaq: MDWD) (the “Company”), a fully-integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, today announced positive initial data from eleven patients in its ongoing open-label Phase I/II study of MW005 for the treatment of low-risk Basal Cell Carcinoma (BCC). The initial data shows MW005 to be safe and well-tolerated, with a majority of the patients who completed the study achieving complete histological clearance of their target lesions following treatment with MW005. The Company anticipates announcing the final data in the second half of 2022.
In the first cohort, eleven patients with either superficial or nodular BCC were treated. Patients enrolled into the study received seven topical applications of MW005, once every other day. At the end of eight weeks post treatment period, all patients undergo complete excision, and the specimen is subject to an independent histological clearance examination. Based on the data generated to date, MW005 is safe, well-tolerated and an effective treatment for BCC with a majority of patients who completed the study demonstrating a complete histological clearance of target lesions.
“Non-melanoma skin cancers are the most common of all types of cancer and represent a significant potential market opportunity for MediWound,” said Ofer Gonen, Chief Executive Officer of MediWound. “We recognize that there is a high unmet need for a non-surgical treatment that achieves high rates of clinical and histological clearance with a safe profile. The data continues to validate our technology, providing us with multiple strategic alternatives to advance the development of this asset.”
Prof. Lior Rosenberg, Chief Medical Technology Officer at MediWound said, “These encouraging results from the Phase I/II clinical trial of MW005 suggest that we are on a path to potentially offer a topical treatment for patients with BCC that would be an alternative to surgical excision of these lesions. The data is in line with the previously published clinical experience we had and provides further clinical proof-of-concept.”
BCC is a non-melanoma skin cancer that arises from the basal layer of epidermis and its appendages. According to the American Cancer Society, BCC is the most diagnosed skin cancer in the United States with approximately 4.3 million cases diagnosed every year. The increasing number of diagnosed BCC is a result of better skin cancer detection, increased sun exposure, and greater life expectancy.
About U.S. Phase I/II Study
The Phase I/II open-label single-arm clinical study is designed to evaluate the safety and efficacy of MW005 in BCC using different schedules of administration. The study is comprised of two cohorts of up to 16 adult patients each, with histologically confirmed superficial or nodular BCC. Patients enrolled into the study received seven topical applications of MW005, once every other day. Following the completion of the treatment course, patients are followed-up for eight weeks in which healing status of the wound and adverse events are assessed by the PI. At the end of eight weeks post treatment, all patients undergo complete excision, and the specimen is subject to an independent histological clearance examination. The study’s endpoints include safety and tolerability measurements, as well as efficacy, as measured by the proportion of patients who reach a clinically assessed complete clearance and with complete histological clearance confirmation. The study is being conducted at three leading clinical centers in the United States.
MW005 is a topical biological drug under development for the treatment of non-melanoma skin cancers. Its proprietary formulation is designed to ease self-administration and is based on the same active pharmaceutical ingredient as in NexoBrid® and EscharEx®, a concentrate of proteolytic enzymes enriched in bromelain.
The clinical development program of MW005 is supported by results from several toxicological and other preclinical studies, as well as the vast clinical experience with NexoBrid and EscharEx. In addition, a clinical case series published in a peer review paper, wherein MW005 (a concentrate of proteolytic enzymes enriched in bromelain) was used for destruction of basal cell carcinoma, provides a preliminary clinical proof-of-concept that MW005 may be a safe and effective treatment in this indication.
About MediWound Ltd.
MediWound is a biopharmaceutical company that develops, manufactures, and commercializes novel, cost effective, bio-therapeutic solutions for tissue repair and regeneration. Our strategy leverages our enzymatic technology platform, focused on next-generation bioactive therapies for burn care, wound care and tissue repair.
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 European Union and other international markets and is at registration-stage with the Food and Drug Administration (FDA). NexoBrid is supported by the U.S. Biomedical Advanced Research and Development Authority (BARDA).
EscharEx, our next-generation bioactive topical therapeutic under development in the U.S. for debridement of chronic and hard to heal wounds. EscharEx was well-tolerated and has demonstrated safety and efficacy in the debridement of various chronic and other hard-to-heal wounds, within a few daily applications in several Phase 2 trials. An end-of-phase 2 meeting with the FDA is targeted for the second half of 2022.
MW005, our topical biological drug for the treatment of non-melanoma skin cancers, is a clinical-stage product candidate under development.
Committed to innovation, we are dedicated to improving quality of care and patient lives. For more information, please visit www.mediwound.com.