FAQ

General Company Information

Recce Pharmaceuticals is pioneering the development of a new class of synthetic anti-infectives designed to address the urgent global health threat posed by antibiotic-resistant superbugs.

Recce has progressed its clinical programs to multiple late-stage clinical trials (including Phase I, II and III). These trials are addressing unmet medical needs, including indications such as Diabetic Foot Infections, Acute Bacterial Skin and Skin Structure Infections (ABSSSI), Burn Wound Infections and Urosepsis/UTI.

R327 Topical Gel

  • The company has received approval from the Indonesian Drug and Food Regulatory Authority, Badan POM, to initiate its Registrational Phase 3 clinical trial assessing RECCE® 327 as a topical gel (R327G) for the treatment of diabetic foot infections (DFIs). This significant milestone follows the recent human ethics committee approval to commence patient dosing, underscoring Recce’s clinical research’s alignment with regulatory and ethical standards within Indonesia. With both approvals now secured, the Company remains on track to commence the registrational Phase 3 clinical trial this quarter.
  • The Company completed 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). Patients were treated either daily or every second day, for 14 days. The study achieved its primary endpoints of resolving/curing bacterial infections in DFIs. R327 was well-tolerated in all patients.
  • Upon receiving positive results from the Phase I/II study, Recce received Human Research Ethics Committee approval for a Phase II clinical trial of R327 topical gel for testing against Acute Bacterial Skin and Skin Structure Infections (ABSSSI), with patient dosing now at its final stages, interim data is expected in Q1 2025.
  • Recce enrolled in the Therapeutic Goods Administration (TGA) Special Access Scheme (SAS) Category A for the utilisation of RECCE® 327 Gel (R327G) by a qualified medical practitioner across patients suffering antibiotic-resistant Gram-positive and Gram-negative bacterial infections, where all patients have been either cured or seen a significant improvement.

Civil and Dept of Defense Programs

  • The Company has been awarded grant funding in the amount of US$2 million (approximately A$3 million) by the US Department of Defense in recognition of RECCE® 327 Gel (R327G) as a topical treatment for Burn Wound Infections. The grant funding from the US Department of Defense Congressionally Directed Medical Research Programs (CDMRP) will enable the Company to accelerate the development of R327G and evaluate it as a gel-based treatment to rapidly resolve burn wound infections and minimise the onset of bacteraemia complications, such as sepsis. The project’s main aim is to establish the potential for R327G products to be used in a far forward military setting (point-of-injury).
  • Recce also completed a Phase I/II study, evaluating the topical application of RECCE® 327 (R327) in burn wound infections. Patients treated with R327 showed good indications of safety and tolerability with no serious adverse events reported among patients.

R327 Intravenous

  • The Company has completed a Phase I UTI/Urosepsis 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 completed a Phase I/II Rapid Infusion UTI/Urosepsis trial of R327 IV in healthy subjects. The study delivered positive data, demonstrating that RECCE® 327 (R327) administered intravenously is safe and efficacious against Escherichia Coli (E. coli ). The Phase I/II study included 25 participants who received R327 at doses up to 4,000mg as intravenous infusions over various infusion times.

The Company has been awarded grant funding in the amount of US$2 million (approximately A$3 million) by the US Department of Defense in recognition of RECCE® 327 Gel (R327G) as a topical treatment for Burn Wound Infections. The grant funding from the US Department of Defense Congressionally Directed Medical Research Programs (CDMRP) will enable the Company to accelerate the development of R327G and evaluate it as a gel-based treatment to rapidly resolve burn wound infections and minimise the onset of bacteraemia complications, such as sepsis. The project’s main aim is to establish the potential for R327G products to be used in a far forward military setting (point-of-injury).

The Australian Government has awarded the Company AU$11,172,377 Advanced Overseas Finding for its
Synthetic Anti-Viral Research & Development (R&D) and AU$43,774,907 of Synthetic Antibiotic Research & Development (R&D) applicable expenditure by AusIndustry (a division of the Australian Government’s Department of Industry, Innovation and Science) – AU$54,947,284 across the infectious disease portfolio. This extended the R&D cash rebate to include the Company’s overseas R&D activities, for a period of three years (1 July 2022 to 30 June 2025).

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 property portfolio.

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 James 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.

Development Pipeline

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.

Independent studies undertaken by leading experts in bacteria Mechanism of Action (MoA) analysis have identified R327 to have a multi-faceted MoA: R327 targets and irreversibly bind to essential bacterial proteins; R327 interferes with bacterial cellular metabolism and energy production at or near the cell surface, depleting ATP; R327 kills bacteria rapidly without inducing cell lysis; R327 is rapidly and irreversibly bactericidal.

More information on our Mechanism of Action can be found here

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.

Good Manufacturing Practice (GMP) production involves stringent guidelines set by regulatory authorities like the FDA to ensure consistent quality and safety of pharmaceutical products. It covers all aspects of production, from materials and equipment to staff training and hygiene, preventing errors that can’t be eliminated through quality control.

For Recce Pharmaceuticals, achieving GMP certification is a crucial milestone. The company has successfully produced 5,000 doses of RECCE® 327 (R327) per week under GMP conditions, ensuring these doses can be used in human clinical trials. This supports ongoing Phase I and Phase II trials and prepares for a Phase III trial for diabetic foot ulcer infections. This achievement highlights Recce’s commitment to advancing innovative antibiotics and represents a significant step towards an Investigational New Drug (IND) submission.

Recce’s initial focus is on Diabetic Foot Infections (DFI), an open sore or wound generally located on the bottom of the foot. DFI is among the most common complications of diabetes, occurring in about 15% of patients. The incidence of diabetes worldwide is projected to increase by 55% over the next 20 years, so this problem is only going to get worse. Approximately 75% of diabetic neuropathies is distal symmetric polyneuropathy (DSP). Once peripheral neuropathy develops the annual incidence of ulcer formation increases from less than one percent to greater than 7%. The three-year mortality for people with diabetes increases from 13% to 28% with an ulcer. Several pathogens, such as S. aureus, Enterococcus, P. aeruginosa, and E. coli, typically cause these infections. The total medical cost for treating diabetic foot diseases in the U.S. is estimated at $9-13 billion per year.

A related area of focus is sepsis, a life-threatening inflammatory response to infection that has spread throughout the body, for which no specific treatment options exist. Sepsis is the costliest condition for hospitals to treat, accounting for more than $38 billion in U.S. hospital expenses annually, with no approved treatment options at this time. By 2026, the sepsis and septic shock market is expected to be worth $5.9 billion USD.

A subset 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 $11.6 billion by 2033.

Aggressive infection is the leading cause of death and morbidity in burn wound sufferers. The most relevant and dangerous burn wound infections involve Staphylococcus aureus (S. aureus), a Gram-positive bacteria found on the skin and mucous membranes (most often in the nasal area).

Influenza (flu) is a highly contagious acute respiratory infection caused by influenza viruses. The Centre for Disease Control (CDC) estimates that 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 usually treated in an outpatient setting, severe complications or recurrent sinusitis can occur. 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 infections and skin/soft tissue infections. While its incidence rate is relatively low (< 1/100,000), it is particularly prevalent and difficult to treat in immunocompromised patients or those with underlying lung diseases such as cystic fibrosis. High five-year mortality rates of approximately 47% have been observed in strains resistant to macrolides, a class of antibiotics.

Hospital-acquired infections (HAIs) are caused by deadly Gram-positive and Gram-negative bacteria, collectively known 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.

More information can be found here: Sepsis, UTI/Urosepsis, Burn Wound Infections, Diabetic Foot Infections.

Clinical Trials

Recce has progressed its clinical programs to multiple late-stage clinical trials (including Phase I, II and III). These trials are addressing unmet medical needs, including indications such as Diabetic Foot Infections, Acute Bacterial Skin and Skin Structure Infections (ABSSSI), Burn Wound Infections and Urosepsis/UTI.

R327 Topical Gel

  • The company has received approval from the Indonesian Drug and Food Regulatory Authority, Badan POM, to initiate its Registrational Phase 3 clinical trial assessing RECCE® 327 as a topical gel (R327G) for the treatment of diabetic foot infections (DFIs). This significant milestone follows the recent human ethics committee approval to commence patient dosing, underscoring Recce’s clinical research’s alignment with regulatory and ethical standards within Indonesia. With both approvals now secured, the Company remains on track to commence the registrational Phase 3 clinical trial this quarter.
  • The Company completed 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). Patients were treated either daily or every second day, for 14 days. The study achieved its primary endpoints of resolving/curing bacterial infections in DFIs. R327 was well-tolerated in all patients.
  • Upon receiving positive results from the Phase I/II study, Recce received Human Research Ethics Committee approval for a Phase II clinical trial of R327 topical gel for testing against Acute Bacterial Skin and Skin Structure Infections (ABSSSI), with patient dosing now at its final stages, interim data is expected in Q1 2025.
  • Recce enrolled in the Therapeutic Goods Administration (TGA) Special Access Scheme (SAS) Category A for the utilisation of RECCE® 327 Gel (R327G) by a qualified medical practitioner across patients suffering antibiotic-resistant Gram-positive and Gram-negative bacterial infections, where all patients have been either cured or seen a significant improvement.

Civil and Dept of Defense Programs

  • The Company has been awarded grant funding in the amount of US$2 million (approximately A$3 million) by the US Department of Defense in recognition of RECCE® 327 Gel (R327G) as a topical treatment for Burn Wound Infections. The grant funding from the US Department of Defense Congressionally Directed Medical Research Programs (CDMRP) will enable the Company to accelerate the development of R327G and evaluate it as a gel-based treatment to rapidly resolve burn wound infections and minimise the onset of bacteraemia complications, such as sepsis. The project’s main aim is to establish the potential for R327G products to be used in a far forward military setting (point-of-injury).
  • Recce also completed a Phase I/II study, evaluating the topical application of RECCE® 327 (R327) in burn wound infections. Patients treated with R327 showed good indications of safety and tolerability with no serious adverse events reported among patients. 

R327 Intravenous

  • The Company has completed a Phase I UTI/Urosepsis 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 completed a Phase I/II Rapid Infusion UTI/Urosepsis trial of R327 IV in healthy subjects. The study delivered positive data, demonstrating that RECCE® 327 (R327) administered intravenously is safe and efficacious against Escherichia Coli ( coli). The Phase I/II study included 25 participants who received R327 at doses up to 4,000mg as intravenous infusions over various infusion times.

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.

A pilot study on the efficacy of nebulised RECCE® 327 (R327) for treating lung infections in a mouse model was conducted at Recce’s AntiInfective Research (AIR) unit within Murdoch Children’s Research Institute. 

The pilot study demonstrated a substantial reduction in Mycobacterium abscessus (M. abscessus) colonisation in both lungs of mice treated with nebulised R327. Notably, nebulised R327 significantly decreased M. abscessus bacterial colonisation, and the mice maintained a stable body weight throughout the study period, indicating the treatment’s safety and tolerability. 

This pilot study represents an important step towards exploring new methods of administration across a broad range of therapeutic indications, which pose an increasing threat in healthcare settings globally.

Media Relations

Please contact our media relations personnel listed below.

Please contact our media relations personnel listed below.

Please contact our media relations personnel listed below.

Head of Marketing

Media and Investor Relations (AU)

Media and Investor Relations (US)

Media and Investor Relations (EU)

Miscellaneous

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.

Recce (pronounced Re-Khey) originates from the military term ‘Reconnaissance’ as a military tactic – ‘the aggressive assessment of the disposition of the enemy’. In other words, get troops behind enemy lines, identify the enemy, eliminate the threat, and escape without being noticed.

We have adopted this approach to anti-infectives, where they are designed to:

  • Enter the human body;
  • Find the infection and threat (deadly bacteria and viruses);
  • Eliminate the threat; and
  • Exit without being noticed (side effects)