Announcement PDF Further 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, 23 April 2020: 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. The study was conducted by an independent Contract Research Organisation 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. Log10 CFU/Swab (Mean ± SD)(n=8) Group 1 Treatment Burn wound With infection Day 1 PI** Day 4 PI** % Change 6.05 5.07 2 Burn wound With infection + Marketed Drug [30mg] (Soframycin***) 16.2% 6.00 4.23* 3 Burn wound With infection+ RECCE [10 mg] 29.5% 6.17 4.29* 4 Burn wound With infection+ RECCE [50 mg] 30.5% 6.09 4.08* 5 Burn wound With infection+ RECCE [100 mg] 33.0% 6.15 3.72* 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. Percentage wound contraction (Mean ± SD)(n=8) Group Treatment Day 4 PI 1 Burn wound With infection 0.96 ± 0.54 2 Burn wound With infection + Market Drug [30 mg] (Soframycin) 2.17 ± 0.81* 3 Burn wound With infection+ RECCE [10 mg] 1.89 ± 0.94ns 4 Burn wound With infection+ RECCE [50 mg] 2.55 ± 0.49* 5 Burn 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 “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.” This announcement has been approved for release by Recce Pharmaceuticals Board. 1 2 https://www.ncbi.nlm.nih.gov/books/NBK441868/ https://www.who.int/news-room/fact-sheets/detail/antimicrobial-resistance About Recce Pharmaceuticals Ltd Recce Pharmaceuticals Ltd (ASX: RCE) is pioneering the development and commercialisation 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.