Synthetic anti-infectives developer Recce Pharmaceuticals Ltd (ASX:RCE) has commenced its Phase I/II Diabetic Foot Infections (DFI) clinical trial of patients at Liverpool Hospitals South West’s Sydney Limb Preservation and Wound Research Unit.
The Phase I/II clinical trial is a prospective, interventional study assessing the safety and efficacy of RECCE 327 (R327) as a topical broad-spectrum, dosed daily over 14 days as a potential topical anti-infective treatment for patients with mild skin and soft tissue diabetic foot infections (DFI).
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 Diabetic Foot Infection (DFI) treatment protocols, ensuring daily dosing, wound health, while capturing a broadened patient population.
Diabetes is the leading cause of non-traumatic lower extremity amputations in the US with 14 to 24% of patients with diabetes (who develop a foot ulcer) requiring amputation. Furthermore, foot ulceration leads to 85% of diabetes-related amputations. Treating diabetic foot diseases in the US costs US$9-13 billion every year.
R327 topical dosing of multiple patients in Australia’s largest DFI study is another welcomed advance to the Company’s infectious disease portfolio of clinical programmes,” Recce CEO, James Graham, said.
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.