A Phase II trial of Recce Pharmaceutical’s topical skin infection gel has ‘exceeded expectations’, with 93% of patients achieving the primary efficacy endpoint.
The Australian company’s open-label trial of Recce 327, a topical treatment designed to treat acute bacterial skin and skin structure infections (ABSSSI) and diabetic foot infections (DFIs), reached the primary efficacy endpoint after 14 days using the synthetic anti-infective.
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In addition, 86% of patients treated with R327G had a successful clinical response after seven days.
Otherwise known as R327G, the trial (ACTRN12624000973516) achieved all primary and secondary endpoints with no adverse events (AEs). However, one patient was withdrawn from the study due to pre-existing pain at the wound site that investigators deemed was unrelated to the study drug.
Recce Pharmaceuticals is now looking to push ahead with a registrational Phase III study focusing on DFIs, which has already been approved by the Indonesian Drug and Food Regulatory Authority (Badan POM). The trial is also set to serve as a registrational trial with the US Food and Drug Administration (FDA) and Australian Therapeutic Goods Administration (TGA).
R327G is designed in part as a response to the industry-wide call for more broad-spectrum antibiotics in hopes of pushing back growing rates of antimicrobial resistance that threatens to result in superbugs and ineffective treatments. The FDA estimates that each year in the US at least 2.8 million antibiotic-resistant infections occur, and more than 35,000 people die as a result.
Research by GlobalData found that the global market for anti-bacterial products stood at approximately $8bn at the end of 2024, with that figure expected to rise to $18bn by the end of 2030, with the US set to make up $7.2bn of those sales.
Alan Dunton, chief medical adviser at Recce Pharmaceuticals, said: “Our robust dataset, from pre-clinical, clinical and TGA 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 III 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.”
Elsewhere in the field of antibiotics, TenNor Therapeutics has announced a Phase III trial of its antibiotic candidate, rifasutenizol, which has met all primary endpoints, beating out the current standard of care.
In June 2024, the FDA released finalised guidance on developing drugs for DFIs after releasing draft guidance in October 2023.
