Join our daily newsletter At The Bell to receive exclusive market insights
Recce Pharmaceuticals (ASX:RCE) has been progressing its way – or that for its flagship breakthrough anti-infective drug, R327 – through the checkbox-heavy process of accumulating clinical data for regulatory validation. And with a Phase 3 trial of up to 310 patients now underway, investors should be paying attention.
That’s because on the face of existing data, and years of work from the company, the drug has a clear value proposition. Its breakthrough compound, R327 is already on the radar of the WHO and the USA’s FDA, is best simply described as a synthetic polymer.
Worth noting: It isn’t only a topical drug, it can also be formulated for intravenous (IV) use. It’s a compound where existing data has suggested safety and low side-effect risk, and it’s reportedly superior against existing antibiotics in treating a wide range of infections.
Recce’s drug reflects a potential way to kill harmful bacteria without allowing those bacteria to develop resistance.
And that means it could be a silver bullet for antibiotic-resistant superbugs, especially in hospital settings, but further down the line, potentially as a purchasable product.
A ‘drug’ with a broad range of uses
In a world where the existential threat of superbugs (those bacteria and viruses that evolve on short time-scales to shrug off the effects of conventional antibiotics) is increasingly becoming a part of day-in-day-out reality in hospitals, Recce sits on a potential game-changing treatment.
Its IV R327 formula has been shown as effective in treating urinary tract infections (UTIs), and, R327 has demonstrated efficacy as a formidable weapon against E.coli. So too has the drug proven effective against types of staph infection and gonorrhoea.
The company has also swung its sights to using R327 in the treatment of burn wounds – particularly with a view towards potentially working alongside the lucrative US Department of Defence med-tech market.
But recently, the lion’s share of the company’s focus has swapped to another acute complication of infection: those occurring in diabetic patients who are suffering from foot infections.
And to that end, the company has started dosing up to 310 patients in a Phase III trial that reflects the ultimate data collection stage ahead of potential approvals.
Indonesian trial to serve as smoking gun for R327
With a Phase III trial now kicked off using R327 in Indonesia, treating diabetic foot infections (DFIs), it’s worth looking at what exactly Recce is seeking to pull off, in terms of offering the data that proves its drug to regulators.
Dosing kicked off in September this year with 5 first-class clinical sites activated in the Phase III study, which should be ready for early-stage data readouts as early as Q1 CY2026. Indonesia was selected as a target jurisdiction with an eye towards further approvals throughout the ASEAN region. Indonesia has a diabetes rate of over 1-in-10 adults – leaving Recce with no hurdles towards a large sample size.
The company will use something called the Lipsky Scale to assess the efficacy of R327 in managing post-surgery DFIs; Lipsky is acknowledged by the US FDA as a harmonious assessment tool.
“Thanks to the positive engagements with Indonesia’s Food and Drug Authority … we are pleased to have successfully activated multiple leading clinical sites across Indonesia and [announce] the Registrational Phase 3 DFI patient dosing is underway,” Recce CEO James Graham said.
“With R327G positioned as the first potential treatment for DFI, we see ourselves well positioned to meet the infectious disease challenges among the global rise in diabetes.”
It isn’t just DFI treatments that R327 stands poised to revolutionise. But in proving a wider value proposition, the company needs high-quality data to gain global regulatory approvals.
That’s what these Phase III trials represent: a proof-of-concept for that larger goal of commercialisation.
And with first newsflows to include data readouts in the next six months, the market will be watching.
Disclaimer: HotCopper had a commercial relationship with RCE at the time this article was crafted and published.
