Recce’s RECCE® 327 Gel Advances with Strong Phase II Data, Faces Phase 3 Test

Positive Phase II Results Mark a Milestone

Recce Pharmaceuticals Limited (ASX:RCE) has announced compelling Phase II clinical trial results for its RECCE® 327 topical gel (R327G), designed to treat Acute Bacterial Skin and Skin Structure Infections (ABSSSI), including diabetic foot infections (DFI). The trial demonstrated a 93% primary efficacy endpoint over 14 days, surpassing expectations and confirming the gel’s potential as a novel anti-infective therapy.

The study enrolled 30 patients, with 29 completing the trial. After just 7 days, 86% of patients showed a successful clinical response, increasing to 93% by day 14. Importantly, no serious adverse events were reported, underscoring the treatment’s safety and tolerability.

Implications for Phase 3 and Regulatory Strategy

These results have significant implications for Recce’s ongoing development program. The company plans to advance to registrational Phase 3 trials in both Indonesia and Australia. Notably, the Indonesian trial protocol includes an interim analysis, which could confirm efficacy after approximately 100 patients, substantially fewer than the original 300-patient baseline, potentially accelerating the path to regulatory approval.

Recce’s innovative regulatory approach, combined with the robust Phase II data, supports an accelerated commercialisation timeline targeting market entry by 2026. This is particularly timely given the global urgency to address antimicrobial resistance (AMR), a growing healthcare crisis.

Addressing a Large and Growing Market

The global market for ABSSSI treatments is substantial and expanding, valued at $7.3 billion USD in 2018 and projected to reach $26 billion USD by 2032, growing at a compound annual growth rate (CAGR) of 9.5%. Recce’s CEO, James Graham, highlighted the commercial opportunity alongside the unmet medical need, emphasizing the gel’s rapid efficacy and broad-spectrum activity against resistant bacteria.

Dr Alan Dunton, Chief Medical Advisor, reinforced confidence in the product’s broad-spectrum capabilities, noting its effectiveness against over 500 clinical bacterial isolates, including drug-resistant strains. This positions RECCE® 327 as a promising candidate in the fight against superbugs.

Innovative Synthetic Anti-Infective Pipeline

Recce Pharmaceuticals is pioneering a new class of synthetic anti-infectives, with RECCE® 327 as a flagship product. The company’s pipeline also includes RECCE® 435, an oral therapy for bacterial infections, and RECCE® 529, targeting viral infections. These compounds leverage multi-layered mechanisms to overcome bacterial and viral resistance, a critical advantage over traditional antibiotics.

The World Health Organization and the US FDA have recognised Recce’s efforts, granting designations that facilitate expedited development and market exclusivity. The company’s proprietary manufacturing capabilities further support its clinical and commercial ambitions.

Looking Ahead

With Phase II success firmly in hand, Recce is poised to enter pivotal Phase 3 trials that will be closely watched by investors and the broader healthcare community. The company’s ability to deliver on its accelerated regulatory strategy and demonstrate consistent efficacy and safety in larger patient populations will be critical to unlocking the commercial potential of RECCE® 327 gel.