Clinical Trials

Recce Pharmaceuticals has announced positive patient data from its phase 2 clinical trial into RECCE 327 (R327), for the treatment of acute bacterial skin and skin structure infections (ABSSSIs), including diabetic foot infections (DFI).

R327, a broad-spectrum antibiotic topical gel, was tested in a phase 2 open-label trial that evaluated its safety, tolerability, efficacy and plasma pharmacokinetics when applied directly to the infected area. It demonstrated a 93% primary efficacy endpoint over 14 days, and no serious adverse events.

ABSSSIs, including DFI necrotising fasciitis and post-operative wound infections, have a large healthcare burden, necessitating the use of antibiotics. Data from R327’s study aligns with the US Food and Drug Administration (FDA)’s aim to combat antimicrobial resistance (AMR).

Recce Pharmaceuticals director and chief medical advisor Dr Alan Dunton said: “Our robust data set, from preclinical, clinical and Australian Therapeutic Goods Administration special access scheme use cases, gives us confidence in the potential of our topical gel. These results reflect the broad-spectrum nature and rapid onset of effect of R327G, which positions us well for the upcoming phase 3 trials in Indonesia and Australia. Importantly, Recce has also demonstrated that its R327 anti-infective compounds are effective against diverse species of bacteria, including in vitro, against over 500 clinical isolates, many previously considered as drug resistant.”