As stated above, R327 was not applied as part of a clinical...

As stated above, R327 was not applied as part of a clinical trial. Results must therefore be considered anecdotal, however, the Company is encouraged by them.

A 59-year-old male was categorised as suffering multidrug-resistant P. aeruginosa sinusitis infection. Clinical samples of R327 were released under strict medical oversight having been determined to meet TGA SAS-A criteria, including: ‘seriously ill, where death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.’1

The patient has suffered from sinusitis infections all of their adult life, which had advanced to a multidrug-resistant Gram-negative P. aeruginosa sinusitis infection in their upper nasal eustachian tube. This infection was unresponsive to previous surgeries, all antibiotic treatments attempted including ciproflaxin (negative side effects), Septrim Forte (twice daily) and Doxylin, including last-resort peripherally inserted central catheter (PICC Line) methods of administration in some instances.

Patient X (for reasons of patient confidentiality) dosed according to a strict, dose-escalating protocol applying 5 -10 drops per 20 millilitres of R327 in saline solution, three times a day into the infected area. Using a rubber bulb, Patient X pushed the mixture up into both the left and right nasal passages, toward the ears. Upon applying R327 in the infected area, Patient X noted a minor stinging sensation as the solution reached the area of infection in both nasal passages, subsiding after approximately three minutes.

Within 90 minutes, Patient X recorded their sinuses began to feel clearer, less inflamed and reported less discharge. As Patient X continued their dosing program, it was recorded the stinging sensation subsided over time. Over a three-day period of applying R327 topically via spray to the infected areas in the sinus', Patient X reported a substantial reduction in infected discharge, termination of sweating and a return to normal sleeping patterns with no side effects. Post-dosing program, blood samples were taken and tested. These samples showed no detectable signs of P. aeruginosa infection and no abnormalities.

Not long after the dosing program, the patient reported feeling a return of the initial infection. Following a sinus biopsy, an opportunistic ‘common bacterium’ had taken residence where the P. aeruginosa was previously. Having advanced from a life-threating infection status, it was agreed that the new, unrelated bacterial infection was early in its growth. A course of Septrim Forte cleared the opportunistic bacteria and the initial drug resistant P. aeruginosa remained undetected.

The Company is encouraged by the nasally administrated response of this patient and the formal submission to the TGA of the Special Access Scheme treatment, following its completion. The Company will continue with its clinical trials to assess the safety or efficacy of R327 and/or any related compounds.

James Graham, Chief Executive Officer of Recce Pharmaceuticals said, “We are thrilled by this positive indication for this patient with a terribly, debilitating condition that has been driven over many years by this recalcitrant pathogen.”