Recce Pharmaceuticals Ltd (ASX: RCE, FSE: R9Q) is developing a New Class of Synthetic Anti-Infectives designed to address the urgent global health problems of antibiotic-resistant superbugs.

Recce’s anti-infective pipeline includes a broad-spectrum, synthetic polymer anti-infective: RECCE® 327 (R327) as an intravenous and topical therapy that is being developed for the treatment of serious and potentially life-threatening infections due to Gram-positive and Gram-negative bacteria, including their superbug forms. Through their multi-layered mechanisms of action, Recce’s anti-infectives have the potential to overcome the processes utilised by bacteria and viruses to overcome resistance – a current challenge facing existing antibiotics.

The World Health Organization (WHO) added R327 to its list of antibacterial products in clinical development for priority pathogens, recognising Recce’s efforts to combat antimicrobial resistance. The FDA 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.

Recce wholly owns its automated manufacturing, supporting current clinical trials. Recce’s anti-infective pipeline aims to address synergistic, unmet medical needs by leveraging its unique technologies.

Why work with us

Pioneering a New Class of Anti-Infectives

Recce is advancing a patented, synthetic polymer platform with a unique, multi-layered mechanism of action that disrupts bacterial energy production (ATP). This first-in-class approach is designed to overcome resistance where traditional antibiotics fail.

Clinical Momentum Across Multiple Programs

• Indonesia: Phase 3 Registrational Trial for Diabetic Foot Infections (R327G) is underway, with patient dosing commenced and multiple hospital sites activated.
• Australia: Preparations for a Phase III ABSSSI trial and Phase II UTI/Urosepsis trial are progressing.
• Strong Phase II ABSSSI data showed 93% efficacy at day 14 with no serious adverse events.

Global Recognition and Strategic Partnerships

• Selected by the World Health Organization (WHO) for inclusion in its global antibacterial pipeline report – the only synthetic polymer listed.
• Multiple collaborations with leading institutions, including the U.S. Department of Defense (Burn Wound Program, USD $2M grant) and USAMRIID under a CRADA to test R327 against biothreat pathogens.
• Regional expansion supported by a Memorandum of Understanding with PT Etana Biotechnologies in Indonesia, aligning with ASEAN healthcare markets.

Scalable, Proprietary Manufacturing

Recce wholly owns and operates automated GMP-grade manufacturing, currently producing up to 5,000 doses per week, with rapid scalability to support clinical and future commercial demand.

Strong IP Position

• Broad international patent portfolio with protection extending beyond 2040.
• The FDA granted R327 Qualified Infectious Disease Product (QIDP) designation under the Generating Antibiotic Initiatives Now (GAIN) Act, providing Fast Track Designation and 10 years of market exclusivity post approval.

Focused on High-Impact Indications

Programs target critical unmet needs: diabetic foot infections, burn wound infections, ABSSSI, urosepsis, and hospital-acquired infections – all areas with high resistance and global health priority.