Multiple Patients Dosed in Topical Phase I/II Clinical Trial
Released
Released
Announcement PDF
ASX Announcement
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 CY 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 burn wounds in
adults (Trial ID: ACTRN12621000412831).
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. Methicillin-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 antiinfective pipeline seeks to exploit the unique capabilities of RECCE® technologies targeting synergistic,
unmet medical needs.
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