All 30 Patients Dosed in Recce’s Phase II Trial of RECCE® 327 for Skin Infections

Phase II Trial Completion Marks Key Milestone

Recce Pharmaceuticals (ASX:RCE) has announced the successful dosing of all 30 patients in its Phase II clinical trial evaluating RECCE® 327 topical gel (R327G) for Acute Bacterial Skin and Skin Structure Infections (ABSSSI). This open-label study assessed safety, tolerability, pharmacokinetics, and efficacy with once-daily application over 7 or 14 days.

Interim data from the trial are encouraging, indicating that patients experienced either complete resolution or significant improvement of infection symptoms. Importantly, no serious adverse events were reported, reinforcing the gel’s safety profile. The full dataset is expected to be reviewed by the Data Safety Monitoring Board and released in the first quarter of 2025.

Strategic Progress Toward Regulatory Approval

Building on these promising Phase II results, Recce plans to initiate a Phase III registrational trial in Australia during the first half of 2025. This pivotal study will support submissions to both the US Food and Drug Administration (FDA) and the Australian Therapeutic Goods Administration (TGA). Additionally, the company has secured approval to commence a large Phase III trial in Indonesia targeting diabetic foot infections (DFIs), a significant subset of ABSSSI with high unmet medical need.

The Indonesian trial is notable for its scale and regional importance, positioning Recce to capture commercial opportunities across the ASEAN market. Diabetic patients, who are particularly vulnerable to skin infections and poor outcomes, stand to benefit from this new treatment option.

Addressing a Growing Global Market and Antimicrobial Resistance

The global market for ABSSSI treatments was valued at approximately US$7.3 billion in 2018 and is projected to reach US$26 billion by 2032, driven by a compound annual growth rate of 9.5%. Despite recent advances, there remains a critical need for broad-spectrum antibiotics effective against both Gram-positive and Gram-negative bacteria, especially in the face of rising antimicrobial resistance (AMR).

RECCE® 327’s synthetic polymer formulation is designed to overcome resistance mechanisms and provide rapid, effective treatment even when the causative pathogen is unknown. The FDA has recognised this potential by granting R327 Qualified Infectious Disease Product (QIDP) designation, Fast Track status, and market exclusivity incentives under the GAIN Act.

Looking Ahead

Recce’s CEO James Graham highlighted the gel’s progress, noting the impressive efficacy despite high bacterial resistance levels among trial patients. Chief Medical Advisor Dr Alan W Dunton echoed this optimism, emphasising the potential impact on the ABSSSI market and the company’s clinical development trajectory.

As Recce prepares for Phase III trials, investors and industry watchers will be keenly awaiting the full Phase II data release and subsequent regulatory milestones. Success in these next stages could position RECCE® 327 as a vital new weapon against resistant bacterial infections, with significant commercial and public health implications.