Recce Pharmaceuticals Receives Ethics Approval to Broaden RECCE® 327 Gel Trials Across all Topical Bacterial Skin Infections

• Positions RECCE^® 327 (R327) gel as a potential broad topical therapeutic for all bacterial skin infections
• Human Research Ethics Committee approval received for Phase II trial of R327 for acute bacterial skin and skin structure infections (ABSSSI), including diabetic foot and wound infections
• New site initiation commenced with first patients to be dosed in Q3 2024
• This trial builds upon clinical results of R327 tested against burn wound and diabetic foot infections

SYDNEY, Australia, June 25, 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 received Human Research Ethics Committee (HREC) approval to commence a Phase II trial assessing its lead candidate, RECCE^® 327 (R327), as a topical, broad-spectrum gel for the treatment of acute bacterial skin and skin structure infections (ABSSSI).

“Obtaining HREC approval marks another significant milestone for Recce and the clinicians striving to discover an effective treatment for ABSSSIs,” said James Graham, Chief Executive Officer of Recce Pharmaceuticals. “This accomplishment highlights Recce’s history of successful HREC approvals and underscores the dedication of our clinical and research teams as we advance our topical treatment programs.”

The Phase II trial is an open-label, efficacy study and exploratory evaluation of the systemic bioavailability of single and/or multiple doses of R327 topical gel applied to ABSSSI. The study aims to provide critical data on the R327’s effectiveness in treating a broad range of ABSSSI indications. ABSSSI refers to a bacterial infection of the skin and its related tissues. Examples of skin conditions commonly included in that category are diabetic foot infections (DFI), necrotizing fasciitis, post-operative wound infections, and more.

This study approval allows the Company to bring together the clinical studies of DFIs, wound infections, and more under one key centralized regulatory category of ABSSSI for a broad range of unmet medical needs in the topical bacterial infection landscape. This centralized approach has been made possible by building upon the validated study data to date, including compelling patient outcomes under the TGA Special Access Scheme Category A initiatives.

The study is to be commenced at Barwon Health, one of the largest and most comprehensive regional health services in Australia, working alongside existing leading healthcare providers to broaden the scope of its topical administration. This will enable the trial to access a diverse patient population and provide valuable insights into R327’s performance across various ABSSSI conditions.

The global ABSSSI treatment market size was valued at $7.3B in 2018 and is projected to reach $26B by 2032, representing a CAGR of 9.5% between 2019 and 2032.¹

ABSSSIs present a considerable challenge to the healthcare system. While new antibiotic treatments have recently been developed to combat Gram-positive organisms, there remains a crucial need for antibiotics to address both Gram-positive and Gram-negative pathogens. Furthermore, the rise of antimicrobial resistance in both Gram-positive and Gram-negative bacteria, particularly methicillin-resistant Staphylococcus aureus (MRSA), presents a growing challenge in treating these infections,² with a particular focus on the increase in the prevalence of MRSA being detected among hospitalized patients. Those particularly at high risk of skin infections and poor outcomes from ABSSSI are patients with diabetes.³

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.

Corporate Contact
James Graham
Recce Pharmaceuticals Ltd
+61 (02) 9256 2571
James.graham@recce.com.au

Media & Investor Relations (AU)
Andrew Geddes
CityPR
+61 (02) 9267 4511
ageddes@citypublicrelations.com.au

Media (USA)
Michael Fitzhugh
LifeSci Communications
mfitzhugh@lifescicomms.com

Investor Relations (USA & EU)
Guillame van Renterghem
LifeSci Advisors
gvanrenterghem@lifesciadvisors.com

¹ https://www.fortunebusinessinsights.com/industry-reports/acute-bacterial-skin-and-skin-structure-infections-absssi-treatment-market-100971
² https://www.altmeyers.org/en/dermatology/absssi-132569
³ https://www.sciencedirect.com/science/article/pii/S0168822721000851