Recce Pharmaceuticals Announces Recruitment Passes Halfway in Phase II Trial for Acute Bacterial Skin and Skin Structure Infections

• Phase II trial assessing the efficacy of RECCE^® 327 topical gel (R327G) against acute bacterial skin and skin structure infections
  
• R327G demonstrating promising antibacterial effect across a broad range of human infections
• Clinical study review board on track for mid-October, with interim results to follow
• Trial study locations expand across New South Wales (NSW) and Victoria, broadening access to this potentially novel approach

SYDNEY, Oct. 10, 2024 (GLOBE NEWSWIRE) -- Recce Pharmaceuticals Ltd., (ASX: RCE, FSE: R9Q), (the Company), the Company developing a new class of synthetic anti-infectives, today announced it dosed 15 patients in a Phase II trial evaluating RECCE^® 327 topical gel (R327G) in patients with acute bacterial skin and skin structure infections (ABSSSI). ABSSSI includes diabetic foot infections (DFI) and other wound infections - areas of significant unmet medical need.

"We are thrilled to pass the halfway point of this pivotal Phase II study for the unmet clinical need of topical skin infections. Indications of promising antibacterial effect are significant achievements, with patient recruitment to be completed within the year," said James Graham, Chief Executive Officer of Recce Pharmaceuticals. "The market for ABSSSI is expanding due to an increase in the frequency of bacterial skin infections, particularly those brought on by drug-resistant strains. The acute lack of effective broad-spectrum antimicrobials contributes significantly to this challenge. With our initial data from the Therapeutic Goods Administrations (TGA) Special Access Scheme, which saw dramatic results in several DFI patients, we are excited to complete this trial and the potential of R327G to impact this growing global healthcare need."

R327G has been shown to be safe and well tolerated across subjects, indicating promising antibacterial responses in patients. These initial data represent a significant opportunity to expand the application of R327G's formulation.

ABSSSIs are a significant healthcare concern, with clinical trials addressing indications such as DFIs, necrotizing fasciitis, and post-operative wound infections. The global ABSSSI market size was estimated to be $1.34 billion in 2023 and is expected to reach $2.31 billion in the next 10 years.

The Phase II trial is an open-label, pilot efficacy study and exploratory evaluation of the systemic bioavailability of single and/or multiple doses of R327 as a topical gel for ABSSSIs, designed to evaluate the efficacy and systemic absorption of R327G when applied directly to the infected area. The study is on track to enroll 30 participants by the end of 2024.

In addition to the lead site, Barwon Health, the Company has added two new sites with the Australian Clinical Research Network NSW and ACRN Melbourne.

About Recce Pharmaceuticals Ltd
Recce 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 and emerging viral pathogens.

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.

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James Graham
Recce Pharmaceuticals Ltd
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Andrew Geddes
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