Recce Pharmaceuticals Advances Patient Dosing to Final Stages in Phase II Trial for Acute Bacterial Skin and Skin Structure Infections

• Trial reaches dosing milestone, with 20 of the 30 total patients dosed
• All patients dosed met the primary endpoints of the study, either a cure or notable improvement following treatment with RECCE^® 327 topical gel (R327G)
• Patient dosing on track to be completed by the end of 2024

SYDNEY, Nov. 06, 2024 (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 it is nearing completion of its Phase II trial of RECCE^® 327 topical gel (R327G) for the treatment of acute bacterial skin and skin structure infections (ABSSSI), with 20 patients of the 30 total patients now dosed, interim data underscores R327G promising efficacy and safety profile.

The data demonstrates a strong therapeutic response, with all patients completing treatment with R327G achieving positive outcomes, showing either a complete cure or notable improvement. No Serious Adverse Events (SAEs) have been reported for R327G.

“These interim results reflect a remarkable advancement in our journey to address critical unmet medical needs in anti-infective therapies,” said Alan W Dunton, MD, Chief Medical Advisor of Recce Pharmaceuticals. “The robust response we are seeing with R327G is encouraging, especially as we near the completion of the Phase II trial. Achieving a response of complete cure or notable improvement in all patients treated so far highlights the potential impact of R327G in treating complex bacterial infections, including diabetic foot infections.”

As the trial progresses towards completion by the end of 2024, the Company remains focused on delivering a synthetic anti-infective topical therapy to address ABSSSI, a market estimated to reach $26 billion by 2032.¹ Following the non-DSMB’s unanimous endorsement, this continuation reflects the positive trajectory of R327G’s development and supports its progress toward regulatory evaluation.

For further information on this trial, please refer to the Australia New Zealand Clinical Trial Registry, trial ID ACTRN12624000973516.

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
Seed Media
+61 (02) 9267 4511
andrew@seedmedia.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.grandviewresearch.com/industry-analysis/acute-bacterial-skin-and-skin-structure-infections-absssi-market-report