Recce Pharmaceuticals (ASX: RCE) has entered into a second Cooperative Research and Development Agreement (CRADA) with the U.S. Army Institute of Surgical Research (USAISR), marking an expansion of its collaboration with American military research institutions. The agreement will evaluate the company’s topical formulation, RECCE® 327 Gel (R327G), using USAISR’s validated Walker-Mason rat model of burn wound infection at Joint Base San Antonio-Fort Sam Houston, Texas.
The study aims to assess whether R327G can significantly reduce bacterial burden in infected burn wounds, specifically targeting Methicillin-Resistant Staphylococcus aureus (MRSA) (ATCC43300) and Pseudomonas aeruginosa (ATCC27853). These two pathogens are frequently isolated from burn patients and represent clinically significant bacterial threats in combat casualty care. This second CRADA builds on Recce’s existing collaboration with the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) and follows a recent Congressionally Directed Medical Research Programs (CDMRP) grant award, demonstrating accelerating U.S. Government interest in the company’s R327 platform across multiple operational and therapeutic applications.
Why burn wound infections demand new anti-infectives
Burn wound infections remain one of the leading causes of mortality in burn patients. The clinical challenge is compounded by the growing problem of antimicrobial resistance, which makes existing treatments increasingly inadequate for managing these life-threatening infections. The urgent need for new, broad-spectrum anti-infectives that can rapidly treat wound infections without contributing to resistance has positioned novel approaches like R327G as potential solutions to this unmet medical need.
The Walker-Mason rat model employed by USAISR was developed to mimic battlefield injuries and study systemic responses to burns and subsequent infections. This clinically relevant platform provides a robust testing environment for evaluating burn wound infection and treatment interventions. MRSA and Pseudomonas aeruginosa were selected as target pathogens due to their frequent isolation from burn patients and their clinical significance in both military and civilian healthcare settings.
MRSA represents a major Gram-positive threat with resistance to standard antibiotics, while Pseudomonas aeruginosa is a Gram-negative pathogen known for its intrinsic resistance mechanisms and ability to form biofilms in wound environments. The dual application potential of R327G extends beyond military field deployment to civilian clinical settings.
Burn wound infections affect both combat casualties and civilian patients requiring post-operative care, creating a substantial addressable market. The antimicrobial resistance trend creates sustained demand tailwinds as healthcare systems globally seek alternatives to conventional antibiotics losing efficacy against resistant pathogens.
R327G’s practical advantages for field and clinical deployment
R327G is being developed as a next-generation amorphous gel wound dressing that delivers broad-spectrum anti-infective action through a hydrogel delivery format. The topical formulation of Recce’s lead compound, RECCE® 327, is designed to provide rapid action against both Gram-positive and Gram-negative bacteria, including multidrug-resistant superbugs. The formulation’s practical utility for frontline deployment in military field kits, alongside potential application in clinical settings and post-operative care, positions it as a versatile solution addressing multiple care environments.
| Feature | R327G Advantage |
|---|---|
| Spectrum | Gram-positive and Gram-negative bacteria |
| Resistance Profile | Minimal risk of bacterial resistance development |
| Efficacy Retention | No loss upon repeated use |
| Delivery Format | Hydrogel wound dressing |
| Applications | Military field kits, clinical settings, post-operative care |
The hydrogel delivery format expands the commercial addressable market beyond military applications. Wound care represents a significant market opportunity in civilian healthcare, where post-surgical infections and chronic wounds require effective antimicrobial management. R327G’s design as a wound dressing provides practical advantages for field medics requiring rapid deployment solutions, whilst also meeting the needs of clinical environments where sustained antimicrobial action is required.
CEO commentary on strategic momentum
“We are proud to strengthen our relationship with the United States Army through the establishment of a CRADA with the USAISR. This new agreement, together with our existing collaboration with the United States Army Medical Research Institute of Infectious Diseases, and our recent CDMRP grant award, demonstrates the accelerating U.S. Government interest in R327 across multiple operational and therapeutic applications. We are thankful for the ability of R327G to be delivered as a hydrogel dressing, positions as a truly unique solution for combat wound care and broader military and civilian healthcare needs continues to show promise with the U.S. Government,” said James Graham, Chief Executive Officer.
The CEO’s statement reflects management confidence in the trajectory of government engagement. The establishment of a second CRADA within a short timeframe, combined with the CDMRP grant award, signals institutional validation of the technology platform and potential pathways to procurement contracts.
Recce’s expanding U.S. Government collaboration footprint
The USAISR agreement represents the third major touchpoint with U.S. Government research and funding bodies, establishing a pattern of institutional engagement that de-risks the technology thesis. Each collaboration addresses different aspects of the R327 platform’s potential military and civilian applications.
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CRADA with USAMRIID – The United States Army Medical Research Institute of Infectious Diseases collaboration focuses on highly hazardous biological threat agents and maximum containment research at Biosafety Level 4.
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CRADA with USAISR – The U.S. Army Institute of Surgical Research agreement targets combat casualty care research and burn wound infection treatment.
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CDMRP grant award – Recent funding through Congressionally Directed Medical Research Programs validates the company’s research direction and provides non-dilutive capital.
The World Health Organization (WHO) has added R327, R435, and R529 to its list of antibacterial products in clinical development for priority pathogens, recognising Recce’s efforts to combat antimicrobial resistance. The U.S. Food and Drug Administration granted R327 Qualified Infectious Disease Product designation under the Generating Antibiotic Initiatives Now (GAIN) Act, providing Fast Track Designation and 10 years of market exclusivity post-approval. R327 is also included on The Pew Charitable Trusts’ Global New Antibiotics in Development Pipeline as the sole synthetic polymer and sepsis drug candidate in development.
These regulatory designations provide commercial runway protection that extends the potential revenue period following regulatory approval. The GAIN Act benefits are particularly material for investors assessing the long-term commercial viability of anti-infective development programs, where development costs are high and reimbursement pressures are significant.
The anti-infective pipeline beyond burn wounds
Recce’s technology platform extends beyond burn wound applications through a three-compound pipeline designed to address multiple pathogen types and delivery formats. Each compound targets distinct infection scenarios whilst leveraging the platform’s multi-layered mechanisms designed to overcome resistance.
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RECCE® 327: Intravenous and topical therapy for serious and potentially life-threatening infections due to Gram-positive and Gram-negative bacteria, including superbug forms.
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RECCE® 435: Orally administered therapy for bacterial infections.
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RECCE® 529: Antiviral applications targeting viral infections.
The platform approach provides multiple shots on goal across delivery formats and pathogen types. This diversification strategy reduces binary risk associated with single-asset biotech companies whilst leveraging shared manufacturing and regulatory pathways. Recce wholly owns its automated manufacturing capabilities, supporting current clinical trials and providing potential cost advantages as the pipeline progresses.
What comes next for Recce’s burn wound programme
The USAISR study will evaluate R327G’s bioburden reduction capability in the validated Walker-Mason rat model. Results are expected to inform potential military field kit integration and broader clinical application pathways. Successful study data could accelerate discussions with military procurement channels and position the company for civilian wound care market entry.
The study design targets two of the most clinically significant pathogens in burn wound infections, providing data relevant to both military and civilian healthcare decision-makers. If R327G demonstrates significant bacterial burden reduction, the results could support regulatory submissions and procurement discussions across multiple markets.
The military procurement pathway offers potential for sustained contract revenue, whilst civilian wound care represents a substantial global market opportunity where antimicrobial resistance continues to drive demand for novel treatment options. The broader context of antibiotic resistance as an increasing problem with serious health consequences for military, veteran, and civilian populations supports the U.S. Government’s continued prioritisation of clinical research partnerships to accelerate development of new therapeutic compounds with broad-spectrum antibacterial activity. Recce’s expanding government collaboration footprint positions the company within this strategic priority area.
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