USD 26 Billion Market Opportunity

The global market for Acute Bacterial Skin and Skin Structure Infections (ABSSSI) is expected to grow from USD 7.3 billion in 2018 to USD 26 billion by 2032, highlighting an urgent need for effective new treatments. With the rise of antimicrobial resistance (AMR), demand for novel broad-spectrum antibiotics is at an all-time high.

Recce Pharmaceuticals (ASX:RCE) has taken a major step forward in this space, reporting highly successful Phase II trial results for its RECCE® 327 Gel (R327G), a synthetic anti-infective targeting ABSSSI, including Diabetic Foot Infections (DFI).

CEO Confirms Strong Results

“These impressive results underscore the potential of our topical gel to meet critical unmet medical needs in infection treatment,” said James Graham, CEO of Recce Pharmaceuticals. “As we advance towards registrational Phase III trials in Indonesia and Australia, we are encouraged by the rapid efficacy and strong safety outcomes demonstrated in this study.”

Phase II Trial Exceeds Expectations

Recce’s Phase II clinical trial assessed the efficacy and safety of R327G in ABSSSI patients, including those with DFI. The results exceeded expectations:

• 93% primary efficacy endpoint achieved over 14 days of treatment
• 86% of patients responded positively within seven days
• No serious adverse events (SAEs) reported

The trial included 30 patients, with 29 included in the final analysis. “We saw rapid improvement in patients, reinforcing the unprecedented efficacy of Recce’s synthetic technology,” Graham added.

Phase III Trial Can Achieve Results Faster

Given the high response rates in Phase II, experts now believe Recce’s ongoing Registrational Phase III Diabetic Foot Infection Study in Indonesia can achieve statistically significant results after just 100 patients instead of the originally planned 300.

“The built-in interim analysis within our approved protocol allows us to confirm efficacy earlier,” said Graham. “We anticipate completing this data set by the end of the year.”

Global Expansion Plans in Motion

Recce is also progressing towards Registrational Phase III trials in Australia for ABSSSI and DFI, bringing the drug one step closer to market approval. “With these late-stage clinical trials, we are firmly on the path towards an accelerated commercialisation strategy into 2026,” Graham confirmed.

Industry Leaders Back Recce’s Potential

Dr Alan Dunton, Recce’s Director and Chief Medical Advisor, highlighted the broader impact of the company’s success. “Our robust dataset, from pre-clinical and clinical studies, gives us confidence in the potential of our topical gel,” he said.

R327G has demonstrated broad-spectrum activity against over 500 clinical isolates, including bacteria previously considered drug-resistant. “The strong and rapid onset of effect positions us well for the upcoming Phase III trials in Indonesia and Australia,” Dunton added.

Addressing the Global AMR Crisis

The demand for innovative antibiotics has never been greater. The US FDA has increased its focus on novel treatments like R327G to combat AMR, which threatens to undermine decades of medical progress.

“With our regulatory strategy and late-stage clinical progress, Recce is well-positioned to address this growing health crisis while tapping into a significant commercial opportunity,” Graham concluded.

What’s Next?

With a USD 26 billion global market opportunity over coming years and a pathway to accelerated approval, Recce Pharmaceuticals is in a strong position for commercial success. Investors will be watching closely as Phase III trials progress, with interim analysis results expected by the end of 2025.