Recce Pharmaceuticals Takes Bold Step Forward: Administers First Doses in Phase I/II Clinical Trial of RECCE® 327, a Potential Breakthrough for Diabetic Foot Infections

“Recce Pharmaceuticals Achieves Major Milestone: Administers First Doses in Game-Changing Clinical Trial of RECCE® 327, a Potential Revolution for Diabetic Foot Infections”

SYDNEY, Australia, Aug. 24, 2023 (GLOBE NEWSWIRE) — In a remarkable leap forward, Recce Pharmaceuticals Ltd (ASX: RCE, FSE: R9Q) (the Company) has embarked on a groundbreaking journey, dosing patients in a Phase I/II clinical trial that could redefine the treatment landscape for diabetic foot infections (DFI) using their cutting-edge anti-infective candidate, RECCE® 327 (R327). This is no ordinary trial – it stands as Australia’s most extensive DFI study1, taking place at Liverpool Hospital’s South West Sydney Limb Preservation and Wound Research Unit.

The infusion of R327 through topical dosing in multiple patients within this expansive DFI study marks a pivotal stride in Recce Pharmaceuticals’ mission to transform infectious disease treatment, according to James Graham, the Chief Executive Officer of the Company. He remarked, “This monumental progress underscores our commitment to reshaping the clinical landscape for infectious disease.”

The Phase I/II clinical trial itself is a trailblazing endeavor, a prospective and innovative exploration of R327’s safety and efficacy as a topical, broad-spectrum anti-infective. Patients are administered daily doses over a 14-day span, aiming to revolutionize the treatment of mild skin and soft tissue DFIs.

The trial’s setting at the High-Risk Foot Service (HRFS) of Liverpool Hospital paints a vivid picture of its importance. With over 800 patients grappling with intricate foot diseases annually, of which over 80% are linked to diabetes, the study carries profound implications. Out-patient nurses, equipped with R327 treatment know-how, extend their care to homes, ensuring consistent dosing, wound health, and a more inclusive patient representation.

Diabetes-induced foot complications cast a daunting shadow on healthcare systems, with the U.S. experiencing the brunt of its impact. A staggering 14-24% of diabetic patients with foot ulcers eventually require amputation, and 85% of diabetes-related amputations arise from foot ulceration2. The economic burden of treating diabetic foot diseases in the U.S. soars between $9-13 billion annually3.

This initiative’s significance echoes throughout the medical community and beyond, with RECCE® 327 now poised to redefine the future of diabetic foot infection treatment. For those curious to delve deeper, the Australia New Zealand Clinical Trial Registry (ANZCTR) houses more details under the trial ID ACTRN12623000056695 – Proof of concept study of RECCE® 327 topical anti-infective therapy for mild skin and soft tissue diabetes foot infections (DFIs).

About Recce Pharmaceuticals Ltd

At the forefront of scientific innovation, Recce Pharmaceuticals Ltd (ASX: RCE, FSE: R9Q) is pioneering a paradigm shift in the fight against antibiotic-resistant superbugs and emerging viral threats. With a bold vision, the company is crafting a new era of Synthetic Anti-Infectives, engineered to tackle the pressing global health crises of our time.

Imagine a world where antibiotic resistance and viral outbreaks meet their match. Recce Pharmaceuticals is bringing this vision to life through a cutting-edge anti-infective pipeline, featuring three revolutionary synthetic polymer compounds: RECCE® 327, a dual-action intravenous and topical therapy designed to combat severe and life-threatening infections caused by both Gram-positive and Gram-negative bacteria, including their formidable superbug forms; RECCE® 435, an orally administered solution targeting bacterial infections; and RECCE® 529, tailored to battle viral assailants.

These anti-infectives operate on multiple levels, potentially surmounting the relentless mutation strategies employed by bacteria and viruses – a challenge that has long stymied conventional antibiotics.

Embracing a realm of accelerated possibilities, RECCE® 327 has garnered the esteemed Qualified Infectious Disease Product designation from the FDA under the Generating Antibiotic Initiatives Now (GAIN) Act. This prestigious recognition heralds the Fast Track Designation, coupled with a remarkable 10-year market exclusivity post approval.

Adding to its accolades, RECCE® 327 stands proudly on The Pew Charitable Trusts Global New Antibiotics in Development Pipeline, distinguished as the world’s sole synthetic polymer and sepsis drug candidate under development. While RECCE® 327’s human use approval is still pending further clinical testing, it has positioned itself as a beacon of potential in the realm of transformative medicine.

Recce’s commitment extends beyond innovation; the company exercises full ownership of its automated manufacturing process, a cornerstone bolstering ongoing clinical trials. The anti-infective portfolio’s mission is to harness the inherent power of Recce’s technologies, aimed at addressing unmet medical needs with synergistic precision. As we venture into uncharted territories, Recce Pharmaceuticals is leading the charge in rewriting the narrative of infectious disease treatment, offering hope, progress, and a path forward.

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