MediWound begins pivotal Phase III trial for wound therapy

YAVNE, Israel - MediWound Ltd. (NASDAQ:MDWD), a biopharmaceutical company specializing in enzymatic therapies for tissue repair, has launched a Phase III clinical trial for its product EscharEx®, aimed at treating venous leg ulcers (VLUs). With a market capitalization of $186 million and a strong balance sheet showing more cash than debt, the company is well-positioned to advance this clinical program. The study, known as the VALUE trial, is a global endeavor set to evaluate the safety and effectiveness of EscharEx in debridement and aiding wound closure.

The VALUE trial is a double-blind, placebo-controlled study that will span across 40 sites in the United States and Europe. It is set to enroll 216 patients who will be randomized to receive either EscharEx or a placebo. Participants will undergo up to eight applications of the treatment over a two-week period, followed by ten weeks of standardized wound management. The primary endpoints of the trial will be the incidence of complete debridement and complete wound closure, with secondary endpoints including the incidence of complete granulation tissue and time to wound closure, among others.

MediWound’s CEO, Ofer Gonen, highlighted the significance of the trial, noting that there have been no new FDA-approved treatments in this category since 1965. He expressed confidence in EscharEx’s potential, citing its demonstrated efficacy and safety in multiple Phase II trials. According to InvestingPro data, analysts share this optimism, with price targets ranging from $25 to $36, suggesting significant upside potential from current levels.

An interim analysis is planned once 65% of the patients have completed their treatments, expected in mid-2026. This will allow for any necessary adaptive adjustments to the trial. Supporting the VALUE study, MediWound has formed strategic research collaborations with Solventum, Mölnlycke, and MIMEDX to provide advanced products for consistent wound management.

In addition to the VALUE study, MediWound is preparing for a head-to-head Phase II study comparing EscharEx to collagenase for VLU patients, intended to support a Biologics License Application submission in the U.S. The company is also gearing up for a Phase II/III trial targeting diabetic foot ulcers, anticipated to commence in 2026.

VLUs, which affect about 2% of individuals aged 65 and older in the U.S., often lead to severe pain, infection, and disability. EscharEx, a concentrate of proteolytic enzymes enriched with bromelain, has shown promise in previous trials by effectively debriding chronic wounds and preparing them for healing. InvestingPro analysis suggests the stock is currently undervalued, with a healthy liquidity position reflected in a current ratio of 2.11. Subscribers to InvestingPro can access detailed financial health metrics and 6 additional ProTips that provide deeper insights into MediWound’s investment potential.

This article is based on a press release statement from MediWound Ltd.

In other recent news, Enzon Pharmaceuticals has expanded its board with the appointment of Stephen T. Wills, a seasoned executive with prior roles at Palatin Technologies (NYSE:PTN) and board positions at MediWound, Gamida Cell (OTC:GMDAQ), Cactus (NYSE:WHD) Acquisition Corp, and Amryt Pharma. This move coincides with the formation of a special committee, including Wills, to evaluate a proposal from Viskase Companies. This committee will have full authority to negotiate and make decisions regarding the proposal, although no terms have been received yet.

In parallel developments, MediWound reported its Q3 2024 earnings, highlighting strategic and clinical advancements, including FDA approval for pediatric use of NexoBrid and preparations for Phase 3 clinical trials for EscharEx. The company’s Q3 revenue was $4.4 million, showing a slight decrease from the previous year, but the first 9 months saw an increase to $14.4 million. MediWound also raised $25 million through a private investment and reported cash and equivalents of $46 million.

These are the latest developments for both companies. Please note that the information presented is based on recent events and does not include speculative or promotional content.

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