Recce Pharmaceuticals' Phase II Trial for Acute Bacterial Skin Infections Reaches Midpoint

Recce Pharmaceuticals Ltd. recently announced the dosing of 15 patients in a Phase II clinical trial of their RECCE® 327 topical gel (R327G) aimed at treating acute bacterial skin and skin structure infections (ABSSSI). These infections include diabetic foot infections (DFI) and various wound infections, representing areas with significant unmet medical needs. The trial, which has successfully reached its halfway mark, is expected to complete patient recruitment by the end of the year.

James Graham, Chief Executive Officer of Recce Pharmaceuticals, expressed enthusiasm about the trial's progress, noting the significant achievements in demonstrating R327G's promising antibacterial effects. He highlighted the growing incidence of bacterial skin infections, especially those caused by drug-resistant strains, as a driving factor for the expanding ABSSSI market. Effective broad-spectrum antimicrobials are currently in short supply, which exacerbates the challenge. The initial data from the Therapeutic Goods Administration's Special Access Scheme showed dramatic improvements in several patients with DFI, bolstering expectations for R327G's potential impact on global healthcare.

The safety and tolerability of R327G have been confirmed across subjects, with promising antibacterial responses observed in patients. These initial findings suggest a significant opportunity to broaden the application of R327G's formulation. ABSSSIs pose a major healthcare challenge, with clinical trials focusing on conditions such as DFIs, necrotizing fasciitis, and post-operative wound infections. The global ABSSSI market, valued at approximately $1.34 billion in 2023, is projected to reach $2.31 billion over the next decade.

The Phase II trial is an open-label, pilot efficacy study that also explores the systemic bioavailability of single and multiple doses of R327G. It is designed to evaluate the efficacy and systemic absorption of R327G when applied directly to infected areas. The study aims to enroll a total of 30 participants by the end of 2024. In addition to the lead site at Barwon Health, the company has expanded its trial locations to include two new sites: the Australian Clinical Research Network NSW and ACRN Melbourne.

Recce Pharmaceuticals Ltd., listed on the Australian Securities Exchange (ASX: RCE) and the Frankfurt Stock Exchange (FSE: R9Q), is focused on developing a new class of synthetic anti-infectives to address the urgent global health issues of antibiotic-resistant superbugs and emerging viral pathogens. Their anti-infective pipeline includes three patented, broad-spectrum synthetic polymer anti-infectives: RECCE® 327 (R327) for intravenous and topical treatments of severe bacterial infections, RECCE® 435 (R435) for oral bacterial infection treatment, and RECCE® 529 (R529) targeting viral infections. These anti-infectives leverage multi-layered mechanisms of action to potentially overcome bacterial and viral resistance.

The World Health Organization (WHO) has recognized Recce's contributions by adding R327, R435, and R529 to its list of antibacterial products in clinical development for priority pathogens. The U.S. Food and Drug Administration (FDA) has granted R327 the Qualified Infectious Disease Product designation under the Generating Antibiotic Initiatives Now (GAIN) Act, which provides Fast Track Designation and 10 years of market exclusivity post-approval. Additionally, The Pew Charitable Trusts has included R327 in its Global New Antibiotics in Development Pipeline as the only synthetic polymer and sepsis drug candidate in development.

Recce Pharmaceuticals wholly owns its automated manufacturing facilities, supporting ongoing clinical trials. Their anti-infective pipeline is strategically developed to address synergistic, unmet medical needs by utilizing innovative technologies.