FAQ

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.