MediWound Reports Positive Results from U.S. NexoBrid® Expanded Access Protocol

YAVNE, Israel, Aug. 05, 2024 - MediWound (Nasdaq: MDWD), a leading company in enzymatic therapeutics for tissue repair, has announced positive outcomes from the NEXT Protocol, an Expanded Access Protocol for their product NexoBrid®. Launched in 2019, NEXT aimed to ensure continuous access to NexoBrid® in burn centers pre-commercialization, maintain physician expertise, and gather real-world safety and clinical data.

Dr. Jeremy Goverman, Associate Professor of Surgery at Harvard Medical School, highlighted the significance of the NEXT findings, noting that NexoBrid effectively manages severe burns by speeding up the debridement process and reducing the need for surgery, leading to better patient outcomes. These results align with data from previous Phase III trials, DETECT and CIDS, underscoring NexoBrid's essential role in burn care.

The NEXT Protocol was an open-label, single-arm study conducted at 29 burn centers in the U.S. It involved 239 patients, including 215 adults and 24 children, with deep partial and full-thickness thermal burns covering up to 30% of their total body surface area (TBSA).

Key findings from the NEXT Protocol include:

- Efficacy: NexoBrid achieved complete debridement in 94.9% of adults and 100% of children. Only 4.2% of adults required surgical excision for eschar removal post-treatment, while no children needed surgical intervention. The mean wound area needing surgical excision was 3.6% for adults and 0% for children. Eschar removal was completed in less than a day for both groups.
- Healing and Hospitalization: The median wound closure time was 22 days for adults and 28 days for children. Hospitalization lasted a median of 10 days for both adults and children.
- Safety: The safety profile of NexoBrid remained consistent, with no new safety concerns identified by the Data Safety and Monitoring Board (DSMB). The overall benefit-risk ratio for NexoBrid treatment remained favorable.

NexoBrid® is a topical enzymatic treatment designed to remove nonviable burn tissue (eschar) without damaging healthy tissue. It is approved in over 40 countries, including the U.S., EU, and Japan, and is classified as an orphan biologic drug in these regions.

The development of NexoBrid has been supported by the U.S. Department of Health and Human Services, through BARDA, under contract HHSO100201500035C. This contract facilitated funding and technical support for the pivotal U.S. Phase 3 clinical study (DETECT), the randomized, controlled clinical trial for pediatric use (CIDS), the regulatory approval process, and its availability under the NEXT protocol. Additional projects funded under this BARDA contract include the creation of a pre-emergency use data package and a health economic model to assess cost savings for market adoption in the U.S.

About MediWound
MediWound Ltd. specializes in developing enzymatic therapeutics for non-surgical tissue repair. Their products aim to enhance care and patient experiences while reducing costs and unnecessary surgeries. The company's first drug, NexoBrid®, is FDA and EMA-approved for eschar removal in deep partial and full-thickness thermal burns, significantly cutting down on surgical needs. MediWound’s pipeline includes EscharEx®, a Phase III-ready biologic for chronic wound debridement, which promises substantial benefits over existing products in a market valued at over $360 million.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!