Shares of MediWound (NASDAQ: MDWD) are ticking higher a day after the company reported positive results from its phase 2 study evaluating the safety, pharmacokinetics (transcutaneous absorption) and efficacy of NexoBrid in hospitalized children and adults with severe thermal burns. As a topically administered eschar removal agent, NexoBrid provides a much needed alternative to surgical excision. Surgery of large surfaces of eschar is often limited by the availability of the extensive donor site required. Additionally, surgical excision results in significant surgical burden on these very severe patients including immense blood loss. The phase 2 study included 36 patients with severe burns of 4% to 30% total body surface area (TBSA). Trial results demonstrated NexoBrid as safe and effective. Additionally, the pharmacokinetic profile following NexoBrid’s first and second topical application was comparable, suggesting no concern with accumulation following a second topical application. “Following discussions with the FDA, we amended the protocol for our U.S. Phase 3 DETECT study of NexoBrid to increase patient eligibility from 15% to 30% TBSA. As this study is also a post-approval commitment for European regulators, we obtained the European Medicines Agency’s endorsement for the increase in TBSA in the DETECT study. We are very pleased with the results of the completed PK study and intend to use the data from this study as well as the PK data in large burns obtained from the on-going DETECT study to support a request to FDA and EMA to extend the label for NexoBrid to larger burns,” MediWound CEO Gal Cohen stated in yesterday’s press release.
To learn more, visit www.mediwound.com
About MediWound Ltd.
MediWound is a fully integrated biopharmaceutical company focused on developing, manufacturing and commercializing novel therapeutics based on its patented proteolytic enzyme technology to address unmet needs in the fields of severe burns, as well as chronic and other hard-to-heal wounds. MediWound’s first innovative biopharmaceutical product, NexoBrid, received marketing authorization from the European Medicines Agency for removal of dead or damaged tissue, known as eschar, in adults with deep partial- and full-thickness thermal burns and has been launched in Europe. NexoBrid represents a new paradigm in burn care management, and clinical trials have demonstrated, with statistical significance, its ability to non-surgically and rapidly remove the eschar earlier and, without harming viable tissues. MediWound’s second innovative product, EscharEx® is a topical biological drug being developed for debridement of chronic and other hard-to-heal wounds, a large and growing market. EscharEx® is complementary to the large number of existing wound healing products, which require a clean wound bed in order to heal the wound. EscharEx® contains the same proteolytic enzyme technology as NexoBrid®, and benefits from the wealth of existing development data on NexoBrid®.
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