Recce Pharmaceuticals (ASX: RCE) has entered into a second Cooperative Research and Development Agreement with the United States Army Institute of Surgical Research (USAISR), marking a significant expansion of the company’s collaboration with U.S. military institutions. The Recce Pharmaceuticals U.S. Defense CRADA will evaluate RECCE® 327 Gel (R327G) against two clinically significant bacterial pathogens in infected burn wounds.
This second CRADA builds on Recce’s existing collaboration with the United States Army Medical Research Institute of Infectious Diseases (USAMRIID), positioning the biotech firm as a key partner in advancing next-generation anti-infectives for military and civilian applications. USAISR, located at Joint Base San Antonio-Fort Sam Houston, Texas, is recognised globally as a leader in combat casualty research and burn care.
The study will assess whether R327G can significantly reduce bacterial burden in the Walker-Mason rat model of burn wound infection, specifically targeting Methicillin-Resistant Staphylococcus aureus (MRSA) (ATCC43300) and Pseudomonas aeruginosa (ATCC27853). Both pathogens are frequently isolated from burn patients and represent major contributors to burn wound mortality due to antimicrobial resistance.
Chief Executive Officer James Graham stated: “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.”
The CRADA validates R327G’s potential for practical field deployment as a hydrogel wound dressing, with broader applications extending to clinical settings and post-operative care.
What is a CRADA and why it matters for biotech investors
A Cooperative Research and Development Agreement (CRADA) is a formal partnership between private companies and U.S. federal agencies designed to advance research without direct funding exchange. These agreements allow companies to collaborate with government institutions, leveraging their expertise and facilities whilst retaining intellectual property rights.
For biotech investors, CRADAs represent a critical validation signal. U.S. military institutions conduct rigorous vetting processes before entering into these agreements, assessing both the scientific merit and potential operational utility of technologies under consideration. Securing a CRADA indicates that a company’s platform has passed this stringent evaluation.
CRADAs can also open pathways to future procurement contracts and broader government engagement. Whilst they do not guarantee funding, they position companies favourably for subsequent grant applications, contracts, or adoption into military supply chains.
Recce now has two active CRADAs with U.S. military institutions, demonstrating sustained government interest in its synthetic anti-infective platform across multiple therapeutic applications. This provides non-dilutive validation and establishes commercial pathways that do not require shareholder dilution.
CEO Commentary
“We are thankful for the ability of R327G to be delivered as a hydrogel dressing, which positions it 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.” — James Graham, Chief Executive Officer
R327G targets the antibiotic resistance crisis in burn care
Burn wound infections remain one of the leading causes of mortality in burn patients and are clinically difficult to manage due to the growing challenge of antimicrobial resistance. There is an urgent need for new, broad-spectrum anti-infectives that can rapidly treat wound infections without contributing to resistance development.
R327G is a topical formulation of Recce’s lead compound, RECCE® 327, designed to provide rapid, broad-spectrum anti-infective action against Gram-positive and Gram-negative bacteria, including multidrug-resistant superbugs. The formulation is being developed as a next-generation amorphous gel wound dressing.
The compound’s mechanism offers key differentiators in the burn care space. R327G demonstrates no loss of efficacy upon repeated use and presents minimal risk of bacterial resistance development, addressing the core limitation of conventional antibiotics. This positions the therapy as a potential solution to the escalating crisis of antimicrobial resistance in wound care.
The USAISR study will specifically evaluate R327G’s efficacy against MRSA and Pseudomonas aeruginosa, two major pathogens frequently isolated from burn patients. Both are known for their resistance profiles and their contribution to treatment failure in burn wound infections.
| Feature | R327G Specification |
|---|---|
| Formulation | Amorphous gel wound dressing |
| Spectrum | Gram-positive and Gram-negative bacteria |
| Resistance risk | Minimal development of bacterial resistance |
| Efficacy retention | No loss upon repeated use |
| Target pathogens (USAISR study) | MRSA, Pseudomonas aeruginosa |
R327G addresses an urgent unmet need in both military and civilian burn care. Its differentiated mechanism and resistance profile may provide a competitive moat in the topical anti-infective space, particularly as antimicrobial resistance continues to erode the efficacy of existing treatments.
Practical deployment potential: from battlefield to hospital
R327G’s formulation as a hydrogel wound dressing positions it for practical deployment in frontline military field kits. The Walker-Mason rat model used by USAISR was specifically developed to mimic battlefield injuries and study systemic responses to burns and subsequent infections.
Beyond combat applications, R327G has potential utility across a range of clinical settings. The compound could address wound care needs in hospital burn units, post-operative environments, and trauma care facilities where antimicrobial resistance poses significant treatment challenges.
The dual-use nature of R327G provides commercial optionality. Military adoption could serve as a pathway to civilian clinical markets, whilst regulatory approvals in one domain may support applications in the other.
Potential deployment applications:
- Military field kits for combat wound care
- Clinical burn units
- Post-operative wound management
Recce’s expanding U.S. Government engagement
The USAISR CRADA represents the latest milestone in Recce Pharmaceuticals’ broadening relationship with U.S. Government agencies. The company now has multiple active collaborations and grant awards with military and defence institutions.
U.S. Government collaborations and awards:
- First CRADA with the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) for infectious disease applications
- Second CRADA with the United States Army Institute of Surgical Research (USAISR) for burn wound care
- Recent Congressionally Directed Medical Research Programs (CDMRP) grant award
This strategic pattern demonstrates sustained government interest across multiple R327 applications, spanning infectious diseases, burn care, and broader operational contexts. Multiple touchpoints with U.S. Defense agencies de-risk the development pathway by validating the platform across diverse use cases.
Government recognition may also accelerate clinical development timelines. Access to specialised military research facilities and models (such as the Walker-Mason platform) provides validation infrastructure that would be costly and time-consuming to replicate independently. Future procurement discussions may emerge as data from these collaborations mature.
Regulatory and commercial context
Recce’s lead compound, R327, already holds Qualified Infectious Disease Product (QIDP) designation from the U.S. Food and Drug Administration (FDA) under the Generating Antibiotic Initiatives Now (GAIN) Act. This designation provides Fast Track Designation and 10 years of market exclusivity post-approval.
The GAIN Act was designed to incentivise development of antibiotics targeting serious or life-threatening infections. QIDP designation signals regulatory recognition of R327’s potential to address unmet medical needs in the anti-infective space.
Additionally, the World Health Organization (WHO) has added R327, R435, and R529 to its list of antibacterial products in clinical development for priority pathogens. This recognition acknowledges Recce’s efforts to combat antimicrobial resistance and positions the company’s pipeline within the global health priority framework.
Key regulatory designations:
- QIDP designation under GAIN Act
- FDA Fast Track Designation
- 10 years market exclusivity post-approval
- WHO pipeline inclusion for priority pathogens
These regulatory tailwinds support an accelerated pathway to market and provide extended commercial runway if approval is achieved. Market exclusivity provisions reduce competitive pressure during the critical post-launch period, enhancing the commercial case for investors.
What investors should watch next
Recce Pharmaceuticals now has multiple active streams of validation and development underway. The USAISR collaboration will generate data on R327G’s efficacy in the Walker-Mason burn wound model, whilst the USAMRIID partnership continues to advance infectious disease applications.
Investors should monitor progress across these government collaborations, as study results may serve as catalysts for further commercial or regulatory advancements. The CDMRP grant program will also provide milestones as the company progresses through grant-funded objectives.
Near-term catalysts to monitor:
- USAISR Walker-Mason study results (R327G efficacy in burn wound model)
- USAMRIID collaboration progress updates
- CDMRP grant program milestones
- Clinical trial advancements for R327 pipeline
The clear catalyst pathway provides visibility for investors tracking Recce’s progress. As data from military collaborations emerge, the company may gain additional commercial traction or regulatory momentum that supports broader clinical development.
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Recce Pharmaceuticals’ expanding U.S. Defense collaborations highlight the growing validation of synthetic anti-infectives in addressing antimicrobial resistance. For investors tracking developments across Australian Biotech, Healthcare, and Technology sectors, staying informed on regulatory milestones, partnership announcements, and clinical trial progress is essential for identifying emerging investment opportunities.
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