MediWound shares rose 4.92% to $13.755, with real-time tracking showing a 5.03% gain to $13.77, from a previous close of $13.11, after Chief Executive Officer Ofer Gonen and Chief Financial Officer Barry Wolfenson discussed the company's EscharEx program at an H.C. Wainwright event. Wall Street price targets for the stock range from $22 to $36.
MediWound's bromelain-based wound-care platform has 14 successful clinical trials out of 14 attempts, supported by more than 150 peer-reviewed publications. The company said it holds approvals in the United States, Europe and Japan.
The main upcoming catalyst is the VALUE trial, a Phase 3 study of EscharEx in venous leg ulcers that the company described as the largest wound-care study conducted in the past two decades. The trial is designed to enroll 216 patients across approximately 40 global sites. Patients will be randomized to receive EscharEx or placebo for the first two weeks, followed by standardized treatment. The study is powered at baseline for an 85% to 90% probability of success, with a cost of about $100,000 per patient.
An interim analysis will be triggered after recruitment reaches about 65% of the target, or roughly 140 patients. At that point, the study can continue as planned, increase the sample size by about 50 patients, adding roughly one quarter to the timeline, or increase it by about 120 patients, adding roughly two quarters. CEO Ofer Gonen said an additional 50 patients would cost about $6 million and take about three months. Recruitment completion, the interim analysis and related top-line data milestones are expected by the end of the first quarter of 2027, with top-line results arriving about three months after the interim analysis.
Earlier Phase 2 data from the CHRONEX VLU trial showed complete debridement within two weeks in 63% of patients treated with EscharEx versus 30% for placebo. Head-to-head comparisons also showed EscharEx performed better than Santyl with statistical significance.
NexoBrid, MediWound's burn-care product, has been ordered by about 80 U.S. burn centers since launch. The product is part of a 10-year BARDA contract valued at up to $197 million, with approximately one-third of the value going to MediWound as prime subcontractor and two-thirds to partner Vericel.
Competitor Smith & Nephew's Santyl is a legacy monopoly product that generated about $400 million a year in the United States. It was approved in the 1960s and acquired by Smith & Nephew around 2010. Santyl takes four to eight weeks or more to fully debride a wound, while MediWound's product achieves debridement in about four to five days on average.
Manufacturing modifications are expected to be completed by the end of 2024. Production is expected to begin after completion, with FDA and European Medicines Agency inspections taking place three to six months after production starts. European approval for the new facility is expected around mid-2027. A BARDA-backed backup manufacturing facility for the U.S. government is expected to take about four years to complete.
