Recce Pharmaceuticals Reports Positive Phase I/II Trial Results of RECCE 327 for the Treatment of Diabetic Foot Infections

• Phase I/II trial assessing the safety and efficacy of RECCE 327 (R327), a broad-spectrum anti-infective as a topical treatment, met all primary endpoints
• R327 was well-tolerated in all patients, resolving mild skin and soft tissue diabetic foot infections (DFI), including multidrug-resistant Gram-positive and Gram-negative pathogens
• Data supports imminent domestic and international site expansion
  

SYDNEY, Australia, Jan. 23, 2024 (GLOBE NEWSWIRE) -- Recce Pharmaceuticals Ltd (ASX: RCE, FSE: R9Q), (the Company), the Company developing a new class of synthetic anti-infectives, today announced positive results from a Phase I/II trial assessing the safety and efficacy of its lead synthetic anti-infective candidate, RECCE 327 (R327), in patients with diabetic foot infections (DFI).

“We are pleased that the Phase I/II clinical trial has met all primary endpoints and produced efficacy data to support R327 as a topical agent,” said James Graham, Chief Executive Officer of Recce Pharmaceuticals. “We look forward to expanding the study by accessing a global patient population and further enhancing our portfolio of human efficacy data.”

The Phase I/II trial is an interventional study assessing the safety and efficacy of R327 as a topical broad-spectrum anti-infective treatment for patients with mild skin and soft tissue DFIs. Patients were treated either daily or every second day for 14 days.

The study achieved its primary endpoint of resolving/curing bacterial infections in DFIs. Following this success, Recce will look to expand clinical sites domestically and internationally to access a greater patient population.

Summary of Treated Patients

	Application Frequency	Age (yrs)/ Sex	Wound Location	Clinical Response
Patient 1	Daily	32 / M	Left forefoot lateral aspect	Escalated therapy*
Patient 2	Second Daily	55 / M	Right hallux plantar aspect	Infection resolved/cured
Patient 3	Second Daily	51 / M	Left forefoot plantar aspect	Infection resolved/cured
Patient 4	Daily	70 / M	Left forefoot plantar aspect	Infection resolved/cured
Patient 5	Daily	64 / M	Right hallux dorsal aspect	Infection resolved/cured

Patient 1 (Daily) – (Methicillin-Resistant Staphylococcus aureus infection) *