Recce Pharmaceuticals Ltd.: Multiple Patients Dosed in Topical Phase I/II Clinical Trial
Highlights:
- Multiple Patients Dosed in Phase I/II clinical trial, an important human clinical milestone
- No adverse symptoms reported - R327 well stocked in hospital pharmacy for further patient utilisation
- Interim data readouts expected this quarter with full data end Q4 2021
Sydney Australia, 12 July 2021: Recce Pharmaceuticals Ltd (ASX:RCE) (FSE:R9Q), the Company developing New Classes of Synthetic Anti-infectives is pleased to announce multiple patients have been dosed with RECCE® 327 (R327) in a topical Phase I/II clinical trial at the Fiona Stanley Hospital Burns Unit in Perth, Western Australia.
The single-centre, 30 patient, prospective, interventional study, aims to assess the clinical effectiveness and safety of R327 as a spray-on antibiotic in the treatment of infected chronic burn ulcers.
Clinical Investigator Dr Edward Raby said, “There is a major unmet medical need among patients with severe burn wound infections with this important study a key part in our work to find a solution. The spray-on administration makes application easy, with the potential patient benefit having real world impact beyond.”
Burn wound infections continue to cause significant health problems for patients following a range of burn injuries with current therapeutic options that are sub-optimal and often associated with delayed wound healing. Methicillan-resistant Staphylococcus auereas (MRSA) is one of the leading organisms causing invasive infection in burns across the world, with burn units reporting rates of infection greater than 50%.
Sponsored by the WA Health Department and conducted at Fiona Stanley Hospital, the clinical trial is undergoing two dosing schedules with ten participants receiving R327 daily and a further twenty receiving R327 three times a week as a spray-on administration, over a 14 day study period.
Recce Pharmaceuticals Chief Executive Officer James Graham said, “We are honoured to be working with such a dedicated team of world-leading experts at Fiona Stanley Hospital and look forward to supporting them and their patients in tackling the range of difficult to treat infections faced on a daily basis.”
More information on this trial can be found at the Australia New Zealand Clinical Trials Registry under the trial ID ACTRN12621000412831 – Proof of concept study of RECCE 327 topical antibiotic therapy for infected burn wounds in adults.
This announcement has been approved for release by Recce Pharmaceuticals Board.
About Recce Pharmaceuticals Ltd
Recce Pharmaceuticals Ltd (ASX: RCE, FSE: R9Q) is pioneering the development and commercialisation of New Classes 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 is unique and comprised of broad-spectrum synthetic polymer antibiotics RECCE® 327, RECCE® 435, and RECCE® 529 for viral infections with unique mechanisms of action against hyper-mutation on bacteria and viruses, respectively.
Patented lead candidate RECCE® 327 has been developed for the treatment of blood infections and sepsis derived from E. coli and S. aureus bacteria – including their superbug forms. Recce’s new antibiotic compound, RECCE® 435, has been formulated for oral use.
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 only synthetic polymer and sepsis drug candidate in development.
Recce wholly owns its automated manufacturing, ready to support first-in-human clinical trials. Recce’s anti-infective pipeline seeks to exploit the unique capabilities of RECCE® technologies targeting synergistic, unmet medical needs.
