ASX:Overview
Recce’s new class of synthetic antibiotics demonstrate rapid, potent and broad-spectrum activity including against those that are serious and potentially life-threatening multi-drug resistant pathogens. This new class of antibiotics are bactericidal and therefore kill bacteria rather than inhibiting their growth.
In Minimum Inhibitory Concentration and Minimal Killing/Bactericidal Concentration testing RECCE® 327 demonstrated high potency against a range of Gram-positive and Gram-negative bacteria pathogens including Staphylococcus aureus, Escherichia coli and Pseudomonas aeruginosa and their superbug forms. RECCE® 327 exhibited a fast-acting mechanism of action therefore killing the bacteria at clinically practical rates.
What Bacteria has RECCE antibiotics demonstrated capability against?
Clostridium difficile
Helicobacter pylori
Pseudomonas aeruginosa
Neisseria gonorrhoeae
Escherichia coli
Klebsiella pneumoniae
Staphylococcus aureus
Streptococcus pyogenes
Enterococcus species
Due to their increasingly common resistance to antibiotics, the scientific community have grouped six bacterial pathogens to form the ESKAPE pathogens from the first letters of their scientific names: Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, and Enterobacter species. The ESKAPE pathogens are a leading cause of nosocomial infections across the world.
Further testing of RECCE® antibiotics continued to demonstrate potent antibacterial activity, against deadly pathogens Enterococcus faecalis, Staphylococcus aureus, Klebsiella pneumoniae and Pseudomonas aeruginosa, with availability of Acinetobacter baumannii and Enterobacter species impractical/prohibitively regulated.
Designed with a purpose
The Company has designed a patented, automated, economically attractive manufacturing process for RECCE® 327. It has invested in a purpose built, wholly owned manufacturing facility, compliant with cGMP manufacturing standards.
Furthermore, the manufacturing process is reproducible and has a CMC (Chemistry, Manufacturing, and Controls) data package, essential for clinical study materials.
Conventional antibiotics are naturally derived by certain fungi or soil bacteria and therefore rely on timely fermentation processes that require large scale bacteria culture and then several subsequent purification stages.
In contrast, Recce Pharmaceutical’s synthetic process is efficient giving rise to a 99.9% product yield in several hours. It requires no specialised and expensive waste removal or risk of environmental contamination.
RECCE antibiotics can be formulated for intravenous, topical, nasal, oral and inhaled use.
Current RECCE® 327 development program
INDICATION
DISCOVERY
PRE-CLINICAL
FIH SAFETY & EFFICACY*
REGULATORY SUBMISSION**
Estimated timelines/indications are subject to change in development plans and regulatory requirements/clarifications
FIH - First-in-human
*Testing for RECCE® antibiotic Safety and Efficacy
**Data submissions to regulators for permission to market
There have been no new classes of antibiotics on the market for over 30 years - Recce® 327 has the potential to break that mould. Recce® 327 is a synthetic polymer, designed to target bacteria that cause infectious disease – including ones that are resistant to current antibiotics – the superbugs. Bacterial infections of the blood are deadly and affect an estimated 30 million people world-wide every year - this is where Recce® 327 is designed to act. Recce® 327 is designed to be administered through injection so it can quickly spread through the blood stream.
Recce® 327 is designed to adhere to the outer cell wall of the infectious bacteria through hydrophobic interactions. This weakens the cell wall and internal pressures from within the cell cause the bacteria to burst. The body’s own mechanisms can then clear the infection. Normal non-bacterial cells remain intact as they do not contain high internal pressures.
Tests have shown Recce® 327 is fast acting and as a broad spectrum antibiotic is effective against gram positive and gram negative bacteria including antibiotic resistant superbugs. Following regulatory requirements for new antibiotics, safety and efficacy tests will continue to urgently explore Recce® 327’s ability to address the global threat posed by superbugs. Together we can make antibiotic resistance history – visit recce.com.au to find out more.