Recce Pharmaceuticals Doses Patients in Phase I/II Clinical Trial of RECCE® 327 for Diabetic Foot Infections

• Patients dosed in Phase I/II trial, evaluating RECCE^® 327 (R327) in patients with diabetic foot infections (DFI), currently the largest DFI study in Australia¹
• Clinical trial is underway at South West Sydney Limb Preservation and Wound Research Unit located at Liverpool Hospital NSW, with daily dose visitations of out-patient nurses
• Interim data readouts are expected later this quarter (Q3 CY23)

SYDNEY Australia, Aug. 24, 2023 (GLOBE NEWSWIRE) — Recce Pharmaceuticals Ltd (ASX: RCE, FSE: R9Q) (the Company), the Company developing a new class of synthetic anti-infectives, is pleased to announce it dosed patients in a Phase I/II clinical trial, evaluating the safety and efficacy of its lead anti-infective candidate, RECCE^® 327 (R327), for the treatment of diabetic foot infections (DFI). The trial is underway at Liverpool Hospitals South West’s Sydney Limb Preservation and Wound Research Unit.

“The topical dosing of R327 in multiple patients in Australia’s largest DFI study is another welcomed advance to the Company’s infectious disease portfolio of clinical programs,” said James Graham, Chief Executive Officer of Recce Pharmaceuticals.

The Phase I/II clinical trial is a prospective, interventional study assessing the safety and efficacy of R327 as a topical broad-spectrum anti-infective, dosed daily over 14 days as a potential treatment for patients with mild skin and soft tissue DFIs.

Each year the High-Risk Foot Service (HRFS) at Liverpool Hospital manages approximately 800 patients presenting with complex foot disease, with over 80% occurring in people with diabetes. The study is supported by out-patient (at home) nurses trained in R327 treatment protocols for DFIs, ensuring daily dosing, and wound health, while capturing a broadened patient population.

Diabetes is the leading cause of non-traumatic lower extremity amputations in the United States (U.S.), with 14-24% of patients with diabetes who develop a foot ulcer requiring amputation. Furthermore, foot ulceration leads to 85% of diabetes-related amputations.² Treating diabetic foot diseases in the U.S. costs $9-13 billion every year.³

More information on this trial can be found at the Australia New Zealand Clinical Trial Registry (ANZCTR) under the trial ID ACTRN12623000056695 – Proof of concept study of RECCE® 327 topical anti-infective therapy for mild skin and soft tissue diabetes foot infections (DFIs).

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 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 as an orally administered therapy for bacterial infections; and RECCE^® 529 for viral infections. Through their multi-layered mechanisms of action, Recce’s anti-infectives have the potential to overcome the hypercellular mutation of bacteria and viruses – the challenge of all existing antibiotics to date.

The FDA has awarded RECCE^® 327 Qualified Infectious Disease Product designation under the Generating Antibiotic Initiatives Now (GAIN) Act – labelling it for Fast Track Designation, plus 10 years of market exclusivity post approval. Further to this designation, RECCE^® 327 has been included on The Pew Charitable Trusts Global New Antibiotics in Development Pipeline as the world’s only synthetic polymer and sepsis drug candidate in development. RECCE^® 327 is not yet market approved for use in humans with further clinical testing required to fully evaluate safety and efficacy.

Recce wholly owns its automated manufacturing, which is supporting present clinical trials. Recce’s anti-infective pipeline seeks to exploit the unique capabilities of its technologies targeting synergistic, unmet medical needs.

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)
Jordyn Temperato
LifeSci Communications
jtemperato@lifescicomms.com

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

¹https://www.anzctr.org.au – DFI Clinical Trials
²https://surgery.ucsf.edu/conditions–procedures/diabetic-foot-ulcers.aspx   
³ Zhang P. et al. – “Global epidemiology of diabetic foot ulceration: A systematic review and meta-analysis” (dagger) – Ann. Med. 2017;49:106–116.