Recce Pharmaceuticals Ltd (ASX:RCE, OTC:RECEF) earlier this week reported preclinical efficacy results for R327 in treating ventilator-associated pneumonia, positioning the drug as a potential new class of antibiotic.
The company said tests conducted by the Murdoch Children’s Research Institute in Melbourne showed that R327 was statistically more efficacious than a market comparator in a mouse model. The compound reduced lung bacterial load to near or below the limit of quantification.
It said current market alternatives cannot be solubilised effectively in the lungs. In contrast, Recce confirmed that R327 can be delivered as a fine mist directly to the lung and penetrate the mucosal barrier to reach the infection site.
CEO James Graham told Proactive the outcome offers “an excellent sign of new hope in the fight against superbugs”. He highlighted that mortality rates for ventilator-assisted pneumonia can reach up to 70%, underscoring the need for effective alternatives.
The company also announced that the Hong Kong Special Administrative Region granted a comprehensive family patent for R327. The patent is valid until 2041 and includes rights to manufacture, administer, and market the drug within the region.
Separately, Recce said its Phase 3 trial in Indonesia for diabetic foot ulcer infections is progressing well. Indonesia’s 11% diabetes rate presents a large patient pool. The company said approval in Indonesia could support pathways to other ASEAN and Middle Eastern markets. An interim readout is expected by the end of Q1 2026.
Recce also continues to work with the US Department of Defense across multiple programs. These include studies in burn wound care and chemical countermeasure applications against bacterial threats.
Graham said additional updates are expected before the end of 2025, with the company focused on delivering further efficacy data readouts from multiple ongoing programs.
Proactive:
Welcome back to Proactive. I'm now joined by Recce Pharmaceuticals CEO James Graham. James, good to have you back.
James Graham:
Hello. Good to be with you.
Proactive:
There are quite a few developments happening at Recce. First up, R327 is showing efficacy against pneumonia. Walk us through this finding.
James Graham:
This is a significant finding from a study by Murdoch Children’s Research Institute in Melbourne. The goal was to assess whether our compound could be solubilised effectively in the lungs.
In a leading respiratory mouse model, we reduced ventilator-associated pneumonia bacteria down to near or below the limit of quantification. Compared to a market product that doesn’t dissolve easily in the lung, we were statistically significantly more efficacious. That positions us as a whole new class of antibiotic for ventilator-associated pneumonia.
Proactive:
You’ve now proven that R327 can be delivered directly to the lungs as a mist. How life-changing could that be?
James Graham:
Very. Ventilator-assisted pneumonia has a 30% to 70% mortality rate. It’s hard to treat because bacteria hide within the lung’s mucosal layer. Our data shows R327 penetrates and reaches the bacteria, leading to strong outcomes. This could represent new hope in fighting superbugs.
Proactive:
And you’ve also just received a family patent grant in Hong Kong. What does that cover?
James Graham:
Yes — it's a comprehensive patent that gives us manufacturing and marketing monopolies in Hong Kong until 2041. It covers methods of manufacture, administration, and application. A multi-claim patent we’re thrilled to receive.
Proactive:
Back to Indonesia — how’s the Phase 3 trial progressing there?
James Graham:
Progressing well. We’re trialling R327 for diabetic foot ulcer infections, after completing Phase 1 and 2 in Australia. Indonesia has an 11% diabetes rate, giving us access to large patient populations.
Approval in Indonesia can support registration across ASEAN nations and potentially the Middle East. We expect an interim readout by the end of Q1 next year.
Proactive:
Can investors expect more announcements before the end of 2025?
James Graham:
Yes. We’re continuing our compassionate access Phase 2 study for multidrug-resistant infections, and we’re also active in the US Department of Defense programs — including burn wounds and chemical countermeasures.
Looking ahead, it’s all about efficacy and data readouts.
Proactive:
Recce Pharmaceuticals CEO James Graham — thank you for your time.
James Graham:
Many thanks.