The FY19/20 Military Burn Research Program Idea Development Award seeks to develop non-surgical burn wound debridement methods and materials for scenarios involving pre-hospital environments and prolonged field care. Guild BioSciences has identified this as an opportunity to apply its patented ImmobiZyme[TM] technology to enzymatic burn wound debridement. Our objectives in this project are to demonstrate that through ImmobiZyme[TM] enzymatic proteases will not require cold-chain support, will have improved stability in wound environments, and are less damaging to healthy tissue. Additionally, data on formulation and production method optimization, dose response, treatment administration, and anti-microbial compatibility will be established.

One of the primary advantages of enzymatic debridement is that it can be applied to burn wounds by non-surgical practitioners. This allows medics or other field personnel to provide care without needing a surgical theater. Eliminating the cold-chain requirements of current enzyme-based products through this project enables these treatment methods to be carried in kits by combat medics or civilian paramedics so burn wound debridement can begin at or close to the point of injury and before transport to a care center is available. By starting treatment quickly, the time an individual is in a hypermetabolic state will be shortened, the likelihood for sepsis and mortality will be reduced, and overall patient outcomes will improve vs. current practices. This timing is significant for Soldiers injured far afield with limited transport options. Similarly, the enhancements from the ImmobiZyme[TM] technology improve treatment options for burn wounds that occur during natural disasters, terrorist attacks, or for treating collateral damage to civilian populations in wartime, where the supporting treatment infrastructure is likely overwhelmed or disabled.

The advantages offered by ImmobiZyme[TM] products developed through this project do not stop at the point of injury treatments. The developed materials will be equally effective when used in established care facilities. Reducing the storage condition requirements for enzymatic debridement will make this treatment method even more attractive to care facilities. This can be combined with advantages that come from no longer needing to support a surgical theater for effective treatment, opening opportunities for treatment to out-patient, urgent care, and general practice facilities.

Along with the benefits towards treating burn wounds, results from this effort can be expanded to several enzyme-based topical treatments. The most obvious would be to expand treatment formulations to other types of wounds such as lacerations, pressure or diabetic ulcers, or chronic wounds. Knowledge gained from this effort can also be applied to other enzyme-based topical uses such as alternative anti-microbial treatments, chemical-exposure decontamination, scar reduction, and the promotion of growth and healing. As with burn wound debridement, these treatments could be applied outside of a treatment center depending on the care required, allowing for broad use cases and improved patient outcomes. This type of treatment does not come without risk. The most notable risks involve the formulation of the ImmobiZyme[TM] materials. Because enzymes can be significantly different from one another, methods that lead to favorable properties for one enzyme may not apply directly to a second. This can lead to longer product development times related to the identification of a formulation that leads to the desired product propertied. Similarly, the components of a formulation may lead to unexpected adverse reactions in some patients. Early testing will need to be performed to identify problematic materials and replace or neutralize them.

Although there is a current commercial enzyme-based debridement product and one in Phase III clinical trials, we anticipate that as a new material we will need to go through the full approval process. The projected timeline, assuming we follow standard FDA development outlines, is as follows: lead candidate materials will be identified in 2 years, which will be followed by identification of GMP setup for preclinical and clinical studies. Preclinical testing to establish detailed dosing, toxicity, and efficacy data using animal models will be completed in the following 3 years. The next step will be submitting for an IND approval and clinical trials, which may take an additional 7-9 years to complete depending on both patient opportunities and information learned. Clinically relevant outcomes may start to be available early on in this testing.