Recce Pharmaceuticals Ltd has successfully wrapped up dosing of all 30 patients in its Phase 2 clinical trial of RECCE® 327 Topical Gel (R327G) for the treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI).
New class of anti-infectives
The trial is a key plank of the company's program to develop a new class of synthetic anti-infectives and positions it as a leader in the fight against antibiotic-resistant infections.
“R327G has made significant progress over the last year, confirming its safety profile and demonstrating impressive efficacy as a topical gel formulation, especially considering the high degree of bacterial resistance present in many of the patients being treated in this Phase 2 trial,” CEO James Graham said.
“We look forward to the full dataset, which we expect will further support R327G's progress toward regulatory evaluation."
Recce Pharmaceuticals chief medical advisor Dr Alan W Dunton said: "We are thrilled to see such robust clinical results from our Phase 2 trial.
“These results demonstrate the potential of R327G to address the ABSSSI market. This milestone marks significant progress in our clinical development journey.”
Progress and results
The Phase 2 open-label study evaluated the safety, tolerability, pharmacokinetics and efficacy of R327G, applied once daily over seven or 14 days.
Preliminary data indicates that patients experienced either complete cures or significant improvements in symptoms, with no serious adverse events (SAEs) reported.
Full trial results are expected in the first quarter of this calendar year.
The positive outcomes pave the way for a Phase 3 trial in Australia in the first half of 2025.
This study will serve as a registrational trial for regulatory submissions to the US Food and Drug Administration (FDA) and Australian Therapeutic Goods Administration (TGA).
Broader clinical developments
Recce has also secured approval for a Phase 3 trial of R327G targeting diabetic foot infections (DFIs) in Indonesia.
This initiative will be one of the largest DFI studies globally, potentially opening new commercial opportunities across the ASEAN region.
The global market for ABSSSI treatments, valued at US$7.3 billion in 2018, is projected to grow to US$26 billion by 2032, driven by a compound annual growth rate (CAGR) of 9.5%.
Despite advancements in treating Gram-positive bacteria, there is a pressing need for broad-spectrum solutions like R327G, which can address both Gram-positive and Gram-negative pathogens.
This capability is particularly crucial for diabetic patients and others at high risk of severe infections.
Recce on fast track
As a developer of synthetic anti-infectives, Recce holds patents for R327, R435 (oral bacterial treatment) and R529 (viral infections).
The FDA has granted R327 Fast Track Designation and market exclusivity under the GAIN Act.
The World Health Organization (WHO) and Pew Charitable Trusts have also recognised Recce’s efforts in addressing antimicrobial resistance.