Recce Pharmaceuticals Reports Positive Data from Phase II Trial of RECCE® 327 Gel in Acute Bacterial Skin and Skin Structure Infections, Supporting Accelerated Commercialization Pathway

Yahoo

19-02-2025

Phase II trial assessed the efficacy and safety of RECCE® 327 topical gel in patients with acute bacterial skin and skin structure infections (ABSSSI), including those with diabetic foot infections (DFI)
Study objectives exceeded, with a 93% primary efficacy endpoint achieved for R327G over 14 days of treatment
Data confirms the approach for the approved registrational Phase 3 DFI study in Indonesia, where efficacy can be confirmed earlier in the trial through interim analysis and read-out expected in 2025
Study to progress to registrational Phase 3 trial in Australia for ABSSSI and DFI
Trial results reinforce the unprecedented efficacy of Recce's synthetic technology, now in late-stage clinical trials, facilitated by an innovative regulatory strategy, supporting an accelerated commercialization pathway into 2026
SYDNEY, Feb. 19, 2025 (GLOBE NEWSWIRE) -- Recce Pharmaceuticals Ltd (ASX: RCE, FSE: R9Q), (Recce or the Company), the Company developing a new class of synthetic anti-infectives, today announced positive data from a Phase II trial evaluating RECCE® 327 Topical Gel (R327G) for the treatment of acute bacterial skin and skin structure infections (ABSSSI).
'These impressive results underscore the potential of our topical gel to meet critical unmet medical needs in infection treatment, said James Graham, CEO of Recce Pharmaceuticals. 'As we advance towards registrational Phase 3 trials in Indonesia and Australia, we are encouraged by the rapid efficacy and strong safety outcomes demonstrated in this study. The global ABSSSI treatment market is a substantial commercial opportunity, valued at $7.3B in 2018 and expected to reach $26B by 2032, at a CAGR of 9.5% between 2019 and 2032. Going forward with our clinical programs gives us great confidence in addressing ABSSSI.'
Alan Dunton, MD, Director & Chief Medical Advisor of Recce Pharmaceuticals, added, '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 the 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 in vitro against diverse species of bacteria, including over 500 clinical isolates, many of which were previously considered drug-resistant.'
The Phase II trial successfully demonstrated R327G achieving a 93% primary efficacy endpoint over 14 days, meeting all study endpoints.
After 7 days of treatment, 86% of patients (25 out of 29) treated with R327G had a successful clinical response. At 14 days of treatment, 93% of patients (27 out of 29) achieved a primary efficacy endpoint. R327G demonstrated to be safe and well tolerated, with no serious adverse events (SAE) reported, achieving all endpoints.
The study enrolled 30 patients, with 29 included in the final data analysis. One patient was withdrawn due to pre-existing pain at the wound site that was deemed unrelated to R327G.
Driven by the high response rates in this study, experts have determined the Company's current registrational Phase 3 study for diabetic foot infections (DFI) can meet a statistically significant positive endpoint after completing approximately 100 patients compared to the study baseline of 300 patients. The Indonesian Drug and Food Regulatory Authority (Badan POM) approved protocol has a built-in interim analysis. The Company anticipates completing this data set by the end of the year.
This Phase II study achieved all primary and secondary endpoints as an open-label clinical trial evaluating the safety, tolerability, efficacy, and plasma pharmacokinetics of R327G when applied directly to the infected area. The trial included both men and women with a minimum age of 18 years old and no maximum age limit. The data received from this trial aligns with the US Food and Drug Administration's (FDA) increased demand for novel broad-spectrum antibiotics (such as R327G) to address antimicrobial resistance (AMR). ABSSSIs are a significant healthcare concern, encompassing indications such as DFI, necrotizing fasciitis, and post-operative wound infections. There are no ABSSSI placebo-controlled studies as international regulators deem withholding appropriate treatment of patient infections unethical.
The trial used FDA-accepted diagnostic tools for assessing the severity of patient wounds, including the Lipsky Clinical Resolution of Infection Scale and/or the Bates Jensen Wound Assessment tool. The study's investigators used these methods to evaluate wound healing and subsequently rated patients as either cured or improved. Both assessments (cured/improved) demonstrate that wound healing has been observed, with cured meaning a complete clinical response and improved demonstrating partial wound healing with the potential of a cure beyond the 14-day timeframe.
About Recce Pharmaceuticals LtdRecce Pharmaceuticals Ltd (ASX: RCE, FSE: R9Q) is developing a New Class of Synthetic Anti-Infectives designed to address the urgent global health problems of antibiotic-resistant superbugs.
Recce's anti-infective pipeline includes three patented, broad-spectrum, synthetic polymer anti-infectives: RECCE® 327 (R327) as an intravenous and topical therapy that is being developed for the treatment of serious and potentially life-threatening infections due to Gram-positive and Gram-negative bacteria, including their superbug forms; RECCE® 435 (R435) as an orally administered therapy for bacterial infections; and RECCE® 529 (R529) for viral infections. Through their multi-layered mechanisms of action, Recce's anti-infectives have the potential to overcome the processes utilised by bacteria and viruses to overcome resistance – a current challenge facing existing antibiotics.
The World Health Organization (WHO) added R327, R435, and R529 to its list of antibacterial products in clinical development for priority pathogens, recognising Recce's efforts to combat antimicrobial resistance. The FDA granted R327 Qualified Infectious Disease Product designation under the Generating Antibiotic Initiatives Now (GAIN) Act, providing Fast Track Designation and 10 years of market exclusivity post approval. R327 is also included on The Pew Charitable Trusts' Global New Antibiotics in Development Pipeline as the sole synthetic polymer and sepsis drug candidate in development.
Recce wholly owns its automated manufacturing, supporting current clinical trials. Recce's anti-infective pipeline aims to address synergistic, unmet medical needs by leveraging its unique technologies.
Corporate ContactJames GrahamRecce Pharmaceuticals Ltd+61 (02) 9256 [e-mail]
Media & Investor Relations (AU)Andrew GeddesCityPR+61 (02) 9267 [e-mail]
Media (USA)Michael FitzhughLifeSci [e-mail]
Investor Relations (USA & EU)Guillame van RenterghemLifeSci [e-mail]