Independent Safety Committee unanimously agrees that the Phase I/II trial is safe, well tolerated, and fit for expanded access- Study achieving primary endpoints of safety, tolerability, and efficacy by resolving/curing bacterial infections in patients with diabetic foot ulcers
- RECCE® 327 dosed daily or every second day for 14 days is considered to be safe and well-tolerated
- Additional clinical sites to be launched in
Australia , and additional clinical trials will be launched internationally in diabetic foot infections
The objective of this trial is to evaluate R327’s potential as a topical broad-spectrum anti-infective treatment. An
All parties involved have agreed to broaden the patient description and stage of DFU infection to award greater patient access to the potential benefits of joining the Liverpool Hospital NSW Clinical trial. In the coming months, additional study sites both locally and overseas will become active and include the broader patient population in the study.
Of the estimated 537 million people worldwide who have diabetes, 19–34% will develop a DFU in their lifetime. Approximately 20% of people who develop a DFU will require lower-extremity amputation, either minor (below the ankle), major (above the ankle), or both.1
“I am greatly encouraged by the speed at which my patient's diabetic foot ulcer infections have responded to R327 when applied topically,” said Professor
About
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
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James.graham@recce.com.au
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1 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9797649/
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