RCE Recce Pharmaceuticals

Recce Pharmaceuticals Announces More Positive Data on RECCE® 327 Against MRSA Superbug in Burn Wound Animal Model

Recce Pharmaceuticals Announces More Positive Data on RECCE® 327 Against MRSA Superbug in Burn Wound Animal Model

Highlights:

  • Statistically significant reduction in MRSA superbug bacterial load and higher percentage of wound contraction with RECCE® 327 as compared to Soframycin in rat model for topical burns
  • Study reinforces the potential of RECCE® 327 against drug-resistant superbugs

SYDNEY, Australia, April 23, 2020 (GLOBE NEWSWIRE) -- Recce Pharmaceuticals Ltd (ASX: RCE) (Company), the company developing a new class of broad-spectrum synthetic antibiotics, today announced positive data showing significant in-vivo antibacterial activity against Methicillin-Resistant Staphylococcus aureus (MRSA superbug) in rats with topical burns treated with its lead compound RECCE® 327.

“We are greatly encouraged by the data because it further reinforces RECCE® 327 is potent and keeps on working with repeated efficacy against topical pathogens and superbugs at different dosing levels,” said Dr John Prendergast, Non-Executive Chairman. “Recce’s synthetic antibiotic out-performed the best in class antibiotic Soframycin showing it could be a potential alternative treatment for resistant Staphylococcus aureus, one of the most common bacterial infections in humans.”

The study was conducted by an independent Contract Research Organization to assess the dose-dependency of RECCE® 327 and in-vivo antibacterial activity against MRSA in rats with topical burns. It met its primary endpoints which were a reduction in bacterial load in wound and percentage of wound contraction, evaluated on the fourth day following dosing.

RECCE® 327 was effective in reducing bacterial load within a wound and showed enhanced wound contraction in comparison to the best in class - Soframycin. RECCE® 327 showed repeated efficacy at different dosing levels on topical skin conditions even at low doses. This additional antibacterial efficacy data will be presented to a leading Australian teaching hospital for their anticipated clinical trial considerations.

Bacterial Count Assessment

Five groups of eight rats each showed RECCE® 327 performed better in all instances compared to those who received the optimum dose Soframycin treatment or no treatment. RECCE® 327 continued to show efficacy at different dose levels with significant reduction in bacterial count in the infected wound when compared to the vehicle control (p<0.05). As dosage increased from 10mg to 100mg, there was a further 13.28% decrease in bacterial load.

A photo accompanying this announcement is available at

 Log10 CFU/Swab (Mean ± SD)(n=8) 
GroupTreatmentDay 1 PI**Day 4 PI**% Change
1Burn wound With infection6.055.0716.2%
2Burn wound With infection + Marketed Drug [30mg] (Soframycin***)6.004.23*29.5%
3Burn wound With infection+ RECCE [10 mg]6.174.29*30.5%
4Burn wound With infection+ RECCE [50 mg]6.094.08*33.0%
5Burn wound With infection+ RECCE [100 mg]6.153.72*39.5%

*significantly different from day 1 PI [p<0.05]

** PI – Post Infection

*** Topically marketed antibiotic for the treatment of bacterial infections in burns and wounds

RECCE® 327 showed a significant dose-dependent antibacterial effect when compared to the vehicle control (p<0.05). In this study Soframycin applied twice daily at optimum therapeutic dose whereas a once daily application of RECCE® 327 demonstrated antibacterial efficacy reinforcing RECCE® 327 may be a more potent antibiotic without additional toxicity considerations associated with similar doses of Soframycin.

Wound Contraction/Healing Assessment

RECCE® 327 was further assessed in a wound contraction study. RECCE® 327 showed significant dose-dependent wound healing activity when compared to the vehicle control (p<0.05). Additionally, RECCE® 327 was 180% more effective in wound healing as the dose escalated in comparison to the group that received no treatment.

A photo accompanying this announcement is available at

 Percentage wound contraction (Mean ± SD)(n=8)
GroupTreatmentDay 4 PI
1Burn wound With infection0.96 ± 0.54
2Burn wound With infection + Market Drug [30 mg] (Soframycin)2.17 ± 0.81*
3Burn wound With infection+ RECCE [10 mg]1.89 ± 0.94ns
4Burn wound With infection+ RECCE [50 mg]2.55 ± 0.49*
5Burn wound With infection+ RECCE [100 mg]2.69 ± 1.05*

ns Not significantly different from day 1 PI [p>0.05].

* Significantly different from day 1 PI [p<0.05].

Staphylococcus aureus (S. aureus) is a Gram-positive bacteria found on the skin and mucous membranes. S. aureus is the most dangerous of all of the many common staphylococcal bacteria. This bacteria often causes skin infections; however, it can also cause pneumonia, bone infections, meningitis and other invasive infections.1 Patients with MRSA have significantly longer hospital stays and are estimated to be 64% more likely to die than people with a non-resistant form of the infection.2



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About Recce Pharmaceuticals Ltd

Recce Pharmaceuticals Ltd (ASX: RCE) is pioneering the development and commercialization of a New Class of Synthetic Antibiotics with Broad Spectrum activity designed to address the urgent global health problem of antibiotic resistant superbugs.

Recce antibiotics are unique – their potency does not diminish even with repeated use, which is a common failure associated with existing antibiotic use and the resulting emergence of resistant superbugs.

Patented lead candidate RECCE® 327, wholly owned and manufactured in Australia, has been developed for the treatment of blood infections and sepsis derived from E. coli and S. aureus bacteria – including their superbug forms.

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.

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.



Executive DirectorMedia & Investor Relations (AU)Media & Investor Relations (USA)
   
James GrahamAndrew GeddesMeredith Sosulski, PhD
Recce Pharmaceuticals, Ltd.CityPRLifeSci Communications
+61 (02) 8075 4585+61 (02) 9267 4511
EN
23/04/2020

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