Recce Pharmaceuticals Announces Positive Data Against Streptococcus pneumoniae Sinusitis Infection in Animal Model

01 Apr 2021
www.biospace.com
Qualified Infectious Disease ProductFast Track
SYDNEY, Australia, April 01, 2021 (GLOBE NEWSWIRE) -- Recce Pharmaceuticals Ltd (ASX:RCE, FSE:R9Q) (Company), the Company developing New Classes of Synthetic Anti-Infectives, is pleased to announce animal study data showing positive efficacy of a new anti-infective formulation RECCE® 111 (R111) against Streptococcus pneumoniae (S. pneumoniae) bacterial sinusitis in mice. RECCE® 111 is a non-descript title for an experimental compound, developed in-house, building upon the unique mechanisms of action of RECCE® 327. “We’re continually excited by the potential of Recce’s anti-infective compounds and are encouraged by these positive indications,” said James Graham, Chief Executive Officer of Recce Pharmaceuticals. “Moreover, this further enhances the breadth of Recce’s synthetic polymer platform.” The study was conducted by an independent Contract Research Organization, to assess the dose-dependency of R327 and R1111in-vivo antibacterial activity against S. pneumoniae in a mouse model of acute bacterial rhinosinusitis infection. Efficacy of Recce Anti-infectives in Acute Bacterial Rhinosinusitis Treatment Table Group Treatment Clinical Observation 1 Early infection control (day1 post infection) NAD 2 Infection vehicle control, twice daily, oral, 5 days NAD 3 Positive Control (Azithromycin, oral, 200 mg/kg, twice daily, 5 days) NAD 4 RECCE® 327 (Low dose, Nasal, 50 mg/kg, Twice daily, 5 days) NAD 5 RECCE® 327 (Mid dose, Nasal, 100 mg/kg, Twice daily, 5 days) NAD 6 RECCE® 327 (High dose, Nasal, 500 mg/kg, Twice daily, 5 days) NAD 7 RECCE® 327 (Low dose, IV, 100 mg/kg, Twice daily, 5 days) NAD 8 RECCE® 327 (Mid dose, IV, 500 mg/kg, Twice daily, 5 days) NAD 9 RECCE® 327 (High dose, IV, 1000 mg/kg, Twice daily, 5 days) NAD 10 RECCE® 111 (Low dose, IV, 50 mg/kg, Twice daily, 5 days) NAD 11 RECCE® 111 (Mid dose, IV, 100 mg/kg, Twice daily, 5 days) NAD 12 RECCE® 111 (High dose, IV, 250 mg/kg, Twice daily, 5 days) NAD Efficacy Acute Bacterial Rhinosinusitis NAD: No abnormality detected This bacterium was chosen due to its immediate availability as a recognized sinusitis model. Streptococcus pneumoniae, a Gram-positive bacterium, is a leading cause of bacterial pneumonia and meningitis in the United States, and a common cause of bloodstream infections, also known as sepsis, ear and sinus infections.2 A total of 12 groups of 10 mice each were assessed to determine the effectiveness of R327 and R111 against S. pneumoniae. Three groups were treated with varying intranasal doses twice daily of R327 (50, 100, 500 mg/kg) and showed a significant dose-dependent antibacterial effect when compared to early infection and vehicle control (p<0.05). Three groups of mice were treated with varying intravenous doses of R327 (100, 500, 1,000 mg/kg) which showed significant dose-dependent antibacterial effect when compared to early infection control and vehicle control (p<0.05). Furthermore, three groups from the 12 were treated with varying intravenous doses of R111 (50, 100, 250 mg/kg) which showed a significant dose-dependent antibacterial effect when compared to early infection control and vehicle control (p<0.05). Azithromycin was the positive control in the study given twice daily at 200 mg/kg and showed bactericidal effect when compared to vehicle control at five-days post infection (p<0.05). The Company’s R327 and R111 compounds showed significant antibacterial capability with no abnormalities detected and are expected to be subject to further expanded sinusitis studies in due course. In addition to these studies, the Company’s clinical activities with R327 continues to progress in the background and looks forward to updating shareholders in due course. About Recce Pharmaceuticals Ltd Recce Pharmaceuticals Ltd (ASX:RCE, FSE:R9Q) is pioneering the development and commercialisation of New Classes of Synthetic Anti-Infectives designed to address the urgent global health problems of antibiotic resistant superbugs and emerging viral pathogens. Recce’s anti-infective pipeline is unique and comprised of broad-spectrum synthetic polymer antibiotics RECCE® 327, RECCE® 435 and RECCE® 529 for viral infections with unique mechanisms of action against hyper-mutation on bacteria and viruses, respectively. Patented lead candidate RECCE® 327 has been developed for the treatment of blood infections and sepsis derived from E. coli and S. aureus bacteria – including their superbug forms. Recce’s new antibiotic compound, RECCE® 435, has been formulated for oral use. 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. Further to this designation, RECCE® 327 has been included on The Pew Charitable Trusts Global New Antibiotics in Development Pipeline as the only synthetic polymer drug candidate for treating sepsis currently in development. 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. Corporate Contact James Graham Recce Pharmaceuticals Ltd +61 (02) 8075 4585 James.graham@recce.com.au Media and Investor Relations (AU) Andrew Geddes CityPR +61 (02) 9267 4511 ageddes@citypublicrelations.com.au Media and Investor Relations (USA) Meredith Sosulski, Ph.D. LifeSci Communications +1 929 469 3851 msosulski@lifescicomms.com ______________________ 1 ‘R111’ a non-descript placeholder name for present purposes 2 Figures accompanying this announcement are available at: Efficacy of Recce Anti-Infectives in Acute Bacterial Rhinosinusitis Efficacy Acute Bacterial Rhinosinusitis Histology of Sinuses in Acute Bacterial Rhinosinusitis Animal Model Early Infection Control
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