Recce Pharmaceuticals has shared positive data from a mid-stage study of its RECCE 327 topical gel (R327G) in acute bacterial skin and skin structure infections (ABSSSIs).

The open-label phase 2 trial has been evaluating the safety and efficacy of the candidate when applied directly to the infected area in adults with ABSSSIs, including those with diabetic foot infections (DFIs).

After seven days of treatment, 86% of R327G-treated patients had a successful clinical response and, after 14 days, 93% achieved a primary efficacy endpoint.

R327G was also shown to be safe and well tolerated, with no serious adverse events reported.

Recce said the data confirms the approach for its approved registrational phase 3 DFIs study in Indonesia, adding that it is also expecting to initiate a registrational phase 3 trial in Australia for ABSSSIs and DFIs.

ABSSSIs, including DFIs, necrotising fasciitis and post-operative wound infections, are considered a significant healthcare concern, and there is an increased demand from the US Food and Drug Administration for new broad-spectrum antibiotics to address antimicrobial resistance (AMR).

Declared by the World Health Organization (WHO) as one of the top ten threats to global health, AMR occurs when bacteria, viruses, fungi and parasites change over time and resist the effects of antimicrobial drugs. As a result, infections become harder to treat and the risk of disease spread, severe illness and death increases.

WHO has already added R327, along with two other anti-infectives in Recce’s pipeline, to its list of antibacterial products in clinical development for priority pathogens.

The FDA has also granted R327 Qualified Infectious Disease Product designation under its Generating Antibiotic Initiatives Now Act, providing Fast Track Designation to the treatment as well as ten years of market exclusivity following approval.