RECCE® 327 and R327G
RECCE®327 and R327G are experimental compounds not market approved for use in humans; safety and efficacy are to be determined by present clinical studies. The result shown below must be considered anecdotal; however are presented within continuous disclosure obligations and are not part of any present clinical trials.
Overview
Patient A-E
- New RECCE® 327 Gel (R327G) indicates positive clinical response in the treatment of multiple antibiotic-resistant infections under TGA Special Access Scheme Category A (SAS – Category A)
- R327G administered via new Gel formulation – ex vivo burn wound study indicating 4 to 5-log reduction (>99.99%) against Methicillin-resistant Staphylococcus aureus
- Clinical trial preparations underway across multiple unmet medical needs
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Five total patients treated under TGA SAS Category with R327G – all responded well to treatment with complete eradication of antibiotic-resistant infections
Patient X
- RECCE® 327 (R327) delivers positive human clinical response against multidrug-resistant, Gram-negative P. aeruginosa sinusitis infection, in a single patient use pursuant to the TGA Special Access Scheme Category A (SAS - Category A)
- The patient outcome follows positive results from animal study in sinusitis with Gram-positive bacteria and supports broad spectrum potential of Recce’s anti-infective compounds against life-threatening bacteria
Patient A
Day 0
Day 0
Day 0
After 24 hrs
After 30 days
- Patient A unresponsive to 4 x daily Cephalexin for 10 days.
- Infection spreading and hospital ready.
- With only one dosing application, after 24 hours the infection had clinically responded.
- Redness and swelling reduced.
- No pre-treatment wound debridement.
- No stinging at any point reported.
- R327 Gel worked quickly and effectively.
Patient B
Pre-treatment
Day 7
Day 10
Day 14
- Pre-treatment of R327G showed significant bacterial infection, redness and swelling.
- Upon applying R327G, after seven days, the initial redness and swelling had minimised, with the wound healing and drying up.
- Day 10 post R327G treatment showed no signs of infection, no signs of pus formation and the wound continuing to clear up and heal.
- Day 14 post R327G treatment, the wound has significantly improved and R327G was well tolerated.
- Surgical intervention (commonly limb amputation in diabetic patients) was averted.
Patient C
51-year-old female with a significant wound infection post ankle infusion surgery. Diagnosed with arthritis on her right ankle due to talar avascular necrosis (death of bone tissue due to a lack of blood supply).
Pre-treatment
Day 7
Day 14
Day 21
- Pre-treatment wound swab on Day 0 showed a growing culture of both Gram-positive and Gram-negative bacilli – a deadly pathogen that produces spores, which can survive in environments for many years.
- Day 7 post R327G treatment, the initial redness and swelling of the wound had minimised and found to be drying up.
- Day 14 post R327G treatment, there were no signs of bacterial growth surrounding the wound.
- Day 21 post-treatment, the wound had successfully healed, closed and dried up with no signs of bacterial infection.
- R327G treatment was well tolerated when applied daily.
Patient D
Day 0
Day 3
Day 7
- Pre-treatment of R327G showed significant bacterial infection, redness and swelling around the implant (upper left thigh).
- Post three days after application of R327G, the initial redness and swelling had minimised, with the wound healing and drying up.
- Day 14 post-treatment showed wound was dried up and had improved with no signs of redness or swelling.
- R327G was applied daily and was well-tolerated.
Patient E
Day 0
Day 3
Day 7
- Pre-treatment (Day 1) X-rays showed infection deep within the underlying bone, tissue and around the nail, with signs of initial biofilm formation.
- After 3 days of R327G treatment, the wound is drying up with infection clearing and the toe responding well to treatment.
- Day 7 post R327G treatment showed wound completely dried up, no signs of biofilm surrounding toenail and swelling significantly reduced.
- Surgical intervention (commonly amputation in diabetic patients), which was the next step for this patient, was averted.
Patient X
A 59-year-old male (Patient X*) had been suffering from sinusitis infections all of their adult life. Over time, it had advanced to a multidrug-resistant, Gram-negative Pseudomonas aeruginosa (P. aeruginosa) infection in their upper nasal eustachian tube.
Clinical samples of RECCE® 327 (R327) were released under strict medical oversight having been determined to meet Therapeutic Goods Administration (TGA) Special Access Scheme Category A (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. Patient X 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, 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, cessation 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.
About RECCE® 327
RECCE® 327 (R327) is a synthetic anti-infective developed for the treatment of serious and potentially life-threatening infections due to
Gram-positive and Gram-negative bacteria, including the full suite of ESKAPE pathogens, even in their superbug forms. R327’s novel
mechanism of action (MOA) is designed to safely enter the body, identify and treat an infection, and exit – with the potential to overcome
antimicrobial resistance.
R327, as an IV therapy, is being studied in a broad range of bacterial infections.
Preclinical studies have demonstrated R327’s ability to rapidly and irreversibly shut down bacterial cellular energy ATP production, disrupting important functions within the bacteria, leading to:
- A reduction in protein synthesis
- Depolarization of cellular membranes
- Cell lysis in higher concentrations
This multi-layered MOA uniquely allows it to kill bacteria and keep on killing with repeated use, a challenge of all existing antibiotics.