Shots: 

• Ofer Gonen, CEO at MediWound, in conversation with PharmaShots, sheds light on recent funding from the US Department of Defence to further develop NexoBrid for the US Army 

• NexoBrid an FDA-approved enzymatic therapy to treat severe burns is jointly developed by Vericel and received US FDA approval in Dec’22 

• MediWound secured an additional $6.7M from the US Department of Defence, making the total budget worth $14.4M 

Saurabh: Can we start the conversation about NexoBrid, what is its role? How it works?  

Ofer: NexoBrid® is a biologic drug for the treatment of severe burns. The active pharmaceutical ingredient (API) is a bromelain-based complex mixture of proteolytic enzymes extracted from the stems of pineapples. NexoBrid is approved for the removal of eschar in deep partial and full thickness burns in the U.S., EU, Japan and several other countries.  

For decades, the standard of care for patients with severe burns has been surgery and hospitalization. Since much of the burn tissue is not viable (ie: it will not live), it must be removed it order to enable the healing process. Treatment options will differ depending on whether the burn is deep partial thickness or full thickness. However, surgical excision is not selective, therefore it removes all of the tissue, whether it is dead or viable. This results in blood loss and requires additional surgical grafting procedures which take time and generally lead to less-than-optimal aesthetic outcomes. 

Using NexoBrid in place of surgery enables the patient to progress more quickly. The NexoBrid procedure can be done immediately after hospital admission and takes just four hours. There is virtually no blood loss, and – most importantly – the surgeon can then see which areas of the burn are deep partial thickness versus full thickness and treat the areas appropriately. This can lead to shorter hospital stays and improved healing and aesthetic outcomes. 

Saurabh: Can we talk about the recent funding done from the US DoD (About the funding, its importance and future use, amount)? 

Ofer: Both the U.S. Department of Defense and The Biomedical Advanced Research and Development Authority (BARDA) have provided essential funding to the NexoBrid program for years.  

The latest $14M funding from the DoD is going towards the development of a room temperature stable version of NexoBrid. 

This is important because there are times when it would be optimal to treat burned service members in the field, before taking them to a health care facility. As such, we are developing a room temperature stable version of NexoBrid that can be applied in the field since the current formulation requires refrigeration.  

The recent war in Israel, along with other military conflicts around the world, has underscored the critical importance of casualty preparedness. The vision of NexoBrid's invaluable utility in times of war or mass casualty events has become remarkably evident. 

Saurabh: What are the applications of NexoBrid for DoD and US defense? What are the other areas where NexoBrid has applications beyond defense?  

Ofer: Whether it is within the context of service members fighting in a war or civilians as victims of a mass casualty event, the DoD and BARDA are interested in having tools and therapies at the ready for any given situation. When it comes to burns, NexoBrid provides the capability of treating many patients at the same time, without the need for an operating room. NexoBrid is challenging the standard of care (surgical excision) for patients with deep partial and full thickness burns in all the markets where it has been commercially launched.  

Saurabh: Can you shed some light on how Vericel Corporation fits into the exclusive license agreement that covers NexoBrid's development and commercial rights in North America? 

Ofer: The Vericel partnership with MediWound is a perfect fit. NexoBrid will enhance their burn franchise performance to rival the orthopedic side of their business. NexoBrid complements Vericel’s cell therapy product, Epicel®, a cultured dermal autograft (CEA) that provides skin replacement for patients who have deep dermal or full thickness burns.  

Moreover, the Vericel commercial team is already working with many burn surgeons in the US - the same surgeons who will use NexoBrid. 

Saurabh: What are the plans for the European market? Is MediWound planning to market NexoBrid on its own or looking for a partner?  

Ofer: MediWound has a blended commercial model in Europe. There are direct representatives  in certain countries, distributors in others, and a few locations have agents. We also recently announced a co-promotion deal with PolyMedics covering the DACH and Benelux regions. In addition, we are working with several countries and EU-wide consortiums to ensure that their mass casualty event preparedness programs include NexoBrid, like the United States. 

Saurabh: How does the collaboration between MediWound and the U.S. Department of Defense contribute to the overall development goals of NexoBrid?  

Ofer: This funding helps in multiple ways. First, it facilitated getting the product through the initial clinical development program with FDA approval in December of 2022. It also was instrumental from a product lifecycle management perspective, moving into new indications and formulations. Finally, there is potential for the funding to enhance manufacturing capacity and expedite timely production of this valuable drug.  

Saurabh: Could you elaborate on the potential effects of other projects in MediWound's pipeline, like MW005 and EscharEx, on medical treatments? 

Ofer: Among all of our drugs – either commercially available or in development -  EscharEx® for chronic wound treatment has the largest market potential – over $2B. 

Chronic wounds are a large and growing issue globally. Very high levels of mortality are associated with them, such as with Diabetic Foot Ulcers. The current standards of care for debridement of these wounds, which is required in around 60% of all chronic wounds, are widespread. These range from using surgical instruments, to gels, powered washing equipment, and a legacy enzymatic debridement drug that has been on the market for over 50 years. 

While sharp debridement (surgery) is quick, it has many drawbacks. That is why there are so many other options. However, the gels and the legacy drug are known to be slow acting, leaving healthcare professionals with an unmet need for fast non-surgical debridement. EscharEx will be the answer. With excellent Phase II data already in hand, the drug is set to enter Phase III towards the end of 2024. MediWound will soon announce head-to-head data against the legacy enzymatic debridement drug, which will highlight the product’s relative effectiveness.  

Our product MW005 has a similar story. Surgery is the current standard of care for the treatment of basal cell carcinomas. When surgery is not optimal, topical treatments are prescribed. However, these topicals have been on the market for decades, take many weeks to work, and have suboptimal effectiveness. They also produce negative side effects which are unpleasant for patients. Our API could work as a more targeted and more efficacious solution for treating basal cell carcinomas with fewer side effects.  

Image Source: Canva 

About the Author: 

Ofer Gonen is CEO of MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic therapeutics focused on non-surgical tissue repair. Prior to his CEO appointment in 2022, Mr. Gonen served as CEO of Clal Biotechnology Industries Ltd. (TASE: CBI), Israel’s leading life science investment company, as well as a managing partner at the Anatomy Medical Technologies Fund. Mr. Gonen previously served as the General Manager of Biomedical Investments Ltd., a managing partner at Arte Venture Group, and held a variety of executive positions in the industry. Mr. Gonen received a B.Sc. in Physics, Mathematics and Chemistry from the Hebrew University of Jerusalem, and an M.A. in Economics and Finance from Tel Aviv University, with distinction. He graduated the prestigious “Talpiot” program of the Israeli Defense Forces. 

Related Post: Vericel and MediWound Receive the US FDA’s Approval of NexoBrid for Severe Thermal Burns