Recce Pharmaceuticals Ltd (ASX:RCE, OTC:RECEF) is developing new classes of synthetic ‘anti-infectives’ that it believes will help tackle the urgent global health crisis being caused by antibiotic-resistant ‘superbugs’.
Superbugs are strains of bacteria, viruses, parasites and fungi that are resistant to most of the antibiotics and other medications commonly used to treat the infections they cause, according to the Mayo Clinic.
Antibiotics have been used for millennia, and since penicillin was discovered by Alexander Fleming in the late 1920s, have been used for a myriad of bacterial infections, however, their effectiveness and availability has led to overuse, and some bacteria, superbugs, have developed resistances to them.
Recce’s flagship drug designed to tackle this problem is RECCE(R) 327; studies of it have indicated efficacy against bacterial cells, including their multi-drug resistant superbug forms.
New approach to war on superbugs
Recce Pharmaceuticals was founded by Dr Graham Melrose, a former executive director and head of research at Johnson & Johnson (NYSE:JNJ)’s Asia Pacific arm.
The company’s name, pronounced ‘re-key’, originates from the military term reconnaissance – get troops behind enemy lines, identify the enemy, eliminate the threat and escape without being noticed.
Recce is pioneering a new class of synthetic anti-infectives designed with a unique mechanism of action in order to empower physicians with an effective treatment that may be used repeatedly against a broad range of bacteria and viruses.
Its current treatments include:
- RECCE(R) 327, a fast-acting, broad-spectrum antibiotic effective against gram-positive and gram-negative bacteria, including antibiotic-resistant superbugs;
- RECCE(R) 435, a broad-spectrum synthetic polymer antibiotic formulated for oral use; and
- RECCE(R) 529, a synthetic polymer anti-infective focused on viral indications following Recce’s background antiviral research.
The company has a range of active programs evaluating the safety and efficacy of these treatments, with intravenous and intranasal and topical anti-bacterial programs for R327 advancing to in-human clinical trials.
Recce is particularly bullish about the potential for its R327 treatment.
The lead candidate has continued to demonstrate encouraging efficacy against a range of gram-positive and gram-negative bacterial pathogens as well as viral pathogens, including the SARS-CoV-2 virus, COVID-19.
Recce has completed various in vitro (lab) and in vivo (animal) studies across a broad range of indications throughout the year and is excited to progress human clinical trials.
The 2021 financial year saw further studies conducted to expand existing knowledge on R327’s mechanism of action (MoA), with independent studies, undertaken by world leaders in bacterial MoA analysis and antibiotic profiling, highlighting R327 having a multi-layered MoA.
Crucially, it was demonstrated to be 99.9% effective against the full suite of ESKAPE pathogens, within hours of exposure; ESKAPE pathogens are responsible for 42% of the 50 million bloodstream infections recorded annually.
R327 is the only known antibiotic in clinical development efficacious against all ESKAPE pathogens globally.
In its annual report released in August, Recce outlined the significant progress it made throughout the year.
In July, R327 demonstrated positive efficacy against horrific ‘flesh-eating’ bacteria.
Necrotizing fasciitis, a life-threatening bacterial infection with a mortality rate of up to 80%, is associated with two main strains of bacteria Clostridium perfringens (C. perfringens) and Streptococcus pyogenes (S. pyogenes).
Notably, R327 has been shown to reduce deadly ‘flesh-eating’ bacterial count below limit of quantification (BLOQ) within 24 hours, at varying concentrations.
In addition, R327 BLOQ efficacy is as early as 30 minutes in C. perfringens, a leading bacterial cause of myonecrosis also known as gas gangrene.
Earlier in the year, following encouraging test results from early-stage studies, R327 received a qualified recommendation to advance to stage 2 of the SARS-CoV-2 Antiviral Screening Program for further testing to be conducted by CSIRO.
The results confirmed and extended the findings from the previous report and allowed the half-maximal inhibitory concentration (IC50) of 2,046 parts per million (ppm) and cytotoxicity (CC50) of 5,108 ppm of R327 to be determined.
“Transformational” 12 months
Recce chairman Dr John Prendegast said the company had experienced a transformational 12 months.
“Faced with the prospect of major disruptions, we responded with effective mitigation strategies to protect our people, our financial resources, and our clinical programs,” he said.
“Antibiotic resistance does not stop for a pandemic and in fact, has only become a greater threat to global health.
“We renewed focus on our existing clinical programs while also initiating several new research partnerships and clinical programs.
“The diligence of the team to pursue multiple initiatives under challenging circumstances has greatly enhanced the value of our business and expanded our promising commercial pipeline of anti-infective therapies.
“We are now positioned to deliver on the next major milestones of the business,” Prendegast added.
In other 2021 highlights, Recce:
- Raised approximately A$27.95 million at $1.30 per share from sophisticated and institutional investors;
- Awarded two AusIndustry advanced overseas findings totalling A$26,787,500 for synthetic antibiotic R&D over three years;
- Presented at the World Microbe Forum following confirmation to publish an abstract in the 2021 program;
- Leading US researchers tested R327 and R529 against SARS-CoV-2;
- R327 & R529 demonstrated concentration-dependent reductions in SARS-CoV-2 in vitro study using organoids made from human airway epithelial cells;
- Murdoch Children’s Research Institute to evaluate in vivo activity of R435 oral formulation against H. pylori in pre-clinical studies program;
- Human Research Ethics Committee approval to start Phase I/II Topical Burns Study;
- R327 showed encouraging efficacy in an in vitro screening assay against SARS-CoV-2;
- R327 showed a reduction in SARS-CoV-2 viral genome numbers at 4,000ppm with virus no longer detectable by viral titration;
- Positive human clinical response in patient of R327 under Special Access Scheme Category A;
- Antiviral patent granted in Japan;
- Listed on Frankfurt Stock Exchange under ticker R9Q;
- Antiviral patent granted in Europe; and
- R327 registered on Australia New Zealand Clinical Trial Registry for Topical Burns Study in Humans.
– Daniel Paproth