Multiple Patients Dosed in Topical Phase I/II Clinical Trial
- 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.