General Company Information
The Company has launched a Phase I/II proof-of-concept study, evaluating the safety and
efficacy of topical R327 in patients with mild skin and soft tissue diabetes foot infections (DFIs).
The Company has completed a Phase I randomised, placebo-controlled, parallel, double-blind
trial, with independent examiners confirming in 80 human subjects (eight cohorts), that the
trial achieved all primary study end-points, met international regulatory standards in data and
showed R327 to be safe & well tolerated.
Following the completion of the Phase I study, the Company has commenced a Phase I/II Rapid
Infusion UTI/Urosepsis trial of R327 IV in healthy subjects. The study is designed to evaluate the
safety and ex-vivo efficacy of R327 in urine collected from subjects after dosing.
Based upon positive safety data from the recently completed Phase I randomised, placebo-
controlled, parallel, double-blind study, Recce has initiated a Phase I/II Rapid Infusion
UTI/Urosepsis trial to Recce is currently conducting a Phase I/II study, evaluating the topical application of RECCE® 327 (R327) in patients with burn wound infections.
As announced on 15 January 2023, the Company announced cash receipt of A$6,219,241 from
the Australian Government’s R&D Rebate. The Company also receives R&D Advance’s from
Radium Capital’s at regular intervals throughout the financial year.
In previous years, Recce received two Innovation Connections grants, totalling AU$87,508 plus
goods and services tax from the Australian government’s Department of Industry, Science,
Energy and Resources as part of its Entrepreneurs’ Programme.
The Company has also been awarded the AusIndustry Advanced Overseas R&D Finding. This
Finding will support the Company’s Synthetic Antibiotic Development program with a 43.5%
cash rebate on $17,150,000 of R&D applicable expenditure. This extended the R&D cash rebate to include the Company’s overseas R&D activities, for a period of three years (1 July 2019 to 30
Recce is trading on the Australian Stock Exchange (ASX) under the ticker: RCE and on the
Frankfurt Stock Exchange (FSE) under the ticker: R9Q.
You can find the latest stock information by visiting our Share Price and Tools page.
Please click here to view and download the annual report.
Please click here to view and download the latest RCE Fact Sheet.
Recce currently has four wholly owned patent families, which include over 40 patents or patent
applications and are constantly expanding, broadening, and developing the intellectual
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.
Mr Graham is the Chief Executive Officer of Recce Pharmaceuticals. He was formerly Executive Director and has extensive experience in marketing, business development and commercialisation of early-stage technologies with global potential. Mr Graham has served on Recce’s Board of Directors for six years and has invested in almost every capital raise to date with a focus on expanding Recce’s commercial opportunities and clinical initiatives.
Recce Pharmaceuticals has been granted four Australian Patents to date:
Patent Family 1: Protecting Recce’s unique and highly economical manufacturing process.
Patent Family 2: Protecting Recce’s drug delivery opportunities.
Patent Family 3: Anti-virus agent and method for treatment of viral infection.
Patent Family 4: Process for Preparation of Biologically Active Copolymer.
You can check out our patents here.
Recce’s pipeline is comprised of RECCE® 327 (R327), RECCE® 435 (R435), and RECCE® 529
(R529) – three patented, broad-spectrum, synthetic polymer anti-infectives with a unique
mechanism of action against hyper-mutation in bacteria.
Recce’s lead candidate, R327, is an intravenous (IV) and topical therapy developed for the treatment of serious and potentially life-threatening infections due to Gram-positive and Gram-negative bacteria, including their superbug forms.
R435 is an orally administered therapy for bacterial infections.
R529 is a new synthetic polymer formulation developed for viral indications.
Recce’s anti-infectives are designed to safely enter the body, identify, and treat an infection, and exit. R327’s novel mechanism of action has the potential to overcome antimicrobial resistance. R327 is attracted to the plasma membranes of pathogens via hydrophobic interactions, subsequently weakening microbial cell walls. Importantly, non-bacterial (eukaryotic) cells remain intact since they do not contain high internal pressures.
More information on our Mechanism of Action can be found here
Independent studies undertaken by leading experts in bacteria Mechanism of Action (MoA) analysis have identified R327 to have a multi-faceted MoA: R327 permeabilizes cell membrane and enters the cell; R327 interrupts bacterial cellular energetics via ATP synthesis; cellular division and non-dividing cell functions are disrupted; R327 is rapidly and irreversibly bactericidal.
The emergence of drug-resistant bacteria, commonly known as superbugs, is becoming increasingly challenging to healthcare systems worldwide by making common infections difficult or impossible to treat. The majority of life-threatening nosocomial (hospital-acquired) infections are caused by a group of six bacteria, collectively called ESKAPE pathogens, due to their propensity of ‘escaping’ the biocidal action of antibiotics.
The acronym ESKAPE stands for six different commonly found multi-drug resistant pathogens: Enterococcus faecium (E. faecium), Staphylococcus aureus (S. aureus), Klebsiella pneumoniae (K. pneumoniae), Acinetobacter baumannii (A. baumannii), Pseudomonas aeruginosa (P. aeruginosa) and Enterobacter species.
In preclinical studies, RECCE® 327 has shown to be a fast acting, broad-spectrum antibiotic effective against Gram-positive and Gram-negative bacterial pathogens, such as S. aureus, Escherichia coli (E. coli), P. aeruginosa, and Streptococcus pyogenes (S. pyogenes) with further testing underway for other pathogens.
RECCE® 435 has demonstrated efficacy against H. pylori in an independent study performed in rats. Further preclinical testing to be conducted.
In an in-vitro study, RECCE® 529 demonstrated concentration-dependent reductions in the SARS-CoV-2 (COVID-19) virus.
The presence of bacteria in the bloodstream can be harmful; therefore, RECCE® 327 is
administered intravenously to ensure it does not come into contact with beneficial bacteria
outside of the vasculature.
RECCE® 435 (R435), an oral formulation, is designed to kill the harmful bacteria in the upper
duodenum; when R435 reaches the lower intestine, it is no longer active and has no impact on
the gut microbiome.
Recce has its own manufacturing capabilities with a state-of-the-art facility in Sydney’s Macquarie Park. The automated manufacturing process takes approximately one hour, producing 500 doses per fully automated run with a 99.9% product yield. This in-house facility enables Recce to quickly and efficiently scale up production to meet the demand for clinical trials as the pipeline continues to advance.
Recce’s initial focus is on sepsis, a life-threatening inflammatory response to infection that has spread to the body for which no specific treatment options exist. Sepsis represents the costliest condition for hospitals to treat, accounting for more than $24B in U.S. hospital expenses annually with no approved treatment options at this time. By 2026, the sepsis and septic shock space is expected to be worth $5.9B USD.
A related subpopulation of sepsis patients suffer from urosepsis, which occurs when an untreated urinary tract infection (UTI) spreads to other organs and into the bloodstream. Although UTIs are most often effectively treated with antibiotics, E. coli strains, responsible for 90% of infections, have demonstrated resistance to the current standards of care. The UTI market is expected to reach $11.3B by 2027.
A diabetic foot Infections (DFI), an open sore or wound generally located on the bottom of the foot, is among the most common complications of diabetes, occurring in about 15% of patients. Several pathogens, such as S. aureus, Enterococcus, P. aeruginosa, and E. coli, typically cause DFU infections. The total medical cost for treating diabetic foot diseases in the U.S. is $9-13 billion per year.
Aggressive infection is the leading cause of death and morbidity of burn wound sufferers. The most relevant and dangerous of burn wound infections are those involving Staphylococcus aureus (S. aureus), a Gram-positive bacteria located on the skin and mucous membranes (most often the nasal area).
Inﬂuenza (flu) is a highly contagious acute respiratory infection caused by influenza viruses. There are three types of inﬂuenza viruses: A, B, and C. Inﬂuenza A, more serious than B and C, is the only type known to cause widespread outbreaks. The Centre for Disease Control (CDC) estimates influenza has resulted in 9 – 45 million infections annually in the U.S. since 2010. Bacterial sinusitis, a mild infection of the tissue lining the sinuses, affects 28.9 million people in the U.S. each year, making it one of the most common health problems. While it is usually treated in an outpatient setting, patients occasionally can develop severe complications and/or have recurrent sinusitis. 11.6% of adults in the U.S. are diagnosed with chronic sinusitis annually.Mycobacteroides abscessus (M. abscessus) is a species of rapidly growing multi-drug resistant nontuberculous mycobacteria that commonly causes chronic lung infection and skin and soft tissue infection. While it has a relatively low incidence rate (< 1/100,000), it is particularly prevalent and more difficult to treat in immunocompromised patients or patients with underlying lung diseases, such as cystic fibrosis. High five-year mortality rates of approximately 47% have been observed in strains that exhibit resistance to macrolides, a class of antibiotics. Hospital acquired infections are caused by deadly Gram-positive and Gram-negative bacteria known collectively as ‘ESKAPE’ pathogens, which are especially dangerous due to their multi- drug resistant properties. In an in vitro study, RECCE® 327 (R327) was shown to be 99.9% effective against the full suite of ESKAPE pathogens within hours of exposure.
The Company has launched a Phase I/II proof-of-concept study, evaluating the safety and efficacy of topical R327 in patients with mild skin and soft tissue diabetes foot infections (DFIs). The Company has completed a Phase I randomised, placebo-controlled, parallel, double-blind trial, with independent examiners confirming in 80 human subjects (eight cohorts), that the trial achieved all primary study end-points, met international regulatory standards in data and showed R327 to be safe & well tolerated.
Following the completion of the Phase I study, the Company has commenced a Phase I/II Rapid Infusion UTI/Urosepsis trial of R327 IV in healthy subjects. The study is designed to evaluate the safety and ex-vivo efficacy of R327 in urine collected from subjects after dosing. Based upon positive safety data from the recently completed Phase I randomised, placebo- controlled, parallel, double-blind study, Recce has initiated a Phase I/II Rapid Infusion UTI/Urosepsis trial to Recce is currently conducting a Phase I/II study, evaluating the topical application of RECCE® 327 (R327) in patients with burn wound infections.
RECCE® 435 demonstrated efficacy against H. pylori in an independent study performed in rats.
Further preclinical testing will be conducted at Murdoch Children’s Research Institute.
In an in-vitro study, RECCE® 529 demonstrated concentration-dependent reductions in the
SARS-CoV-2 (COVID-19) virus. Further testing will be conducted for other major viral infections.
Clinical trials occur in four phases, each assessing safety and/or efficacy in specific patient groups.
Phase I: Performed in healthy volunteers to understand any issues regarding safety, adverse events, dosage, and best administration of the drug.
Phase II: Performed in individuals suffering from the condition that the drug is intended to treat and is used to understand efficacy.
Phase III: Determines the efficacy and safety of the drug in comparison to the established standard of care.
Phase IV: This late-stage trial seeks to determine the long-term effects of a treatment in patients.
- Daniel Astudillo
- Recce Pharmaceuticals Ltd
- +61 (02) 9256 2571
- Andrew Geddes
- +61 (02) 9267-4511
- Jordyn Temperato
- LifeSci Communications
Anti-infective: Anti-infective is a general term that encompasses antibacterials, antibiotics, antifungals, antiprotozoans and antivirals.
Antibiotic: A drug used to treat infections caused by bacteria and other microorganisms. Originally, an antibiotic was a substance produced by one microorganism that selectively inhibits the growth of another.
Unlike current antibiotics, which are typically naturally occurring in certain fungi and soil bacteria, Recce’s anti-infectives are wholly synthetic and based on a patented polymeric structure and have been designed to overcome resistance. Traditional antibiotics inhibit a single target such as bacterial gyrase enzymes, cell wall biosynthetic enzymes, or enzymes required for DNA replication during bacterial cell division. They operate on a ‘lock and key’ mechanism and therefore only bind to a few active sites on the bacterial target. However, if a mutation is introduced into the target site, then the antibiotic will cease to be effective.
Superbugs are strains of microorganisms that have developed resistance to the medications designed to combat them. They pose significant challenges to the successful treatment of commonplace illnesses and have been responsible for numerous widely-reported outbreaks within healthcare facilities in recent times.
Antimicrobial Resistance (AMR) arises when bacteria, viruses, fungi, and parasites evolve over time and cease to be susceptible to medications. This renders infections more challenging to manage, heightening the likelihood of disease transmission, severe illness, and mortality.
Due to this resistance, antibiotics and other antimicrobial drugs lose their effectiveness, making infections progressively more challenging or even impossible to address.