Highlights:
- Murdoch Children’s Research Institute to evaluate the in-vivo antimicrobial activity of RECCE® 435 oral formulation against Helicobacter pylori (H. pylori) in preclinical studies program
- Studies led by H. pylori infectious disease expert Professor Philip Sutton
- Multiple world-first data opportunities over 12 months study program – anticipated human clinical trial beyond
SYDNEY, Australia, Sept. 30, 2020 (GLOBE NEWSWIRE) -- Recce Pharmaceuticals Ltd (ASX: RCE), the Company developing New Classes of Synthetic Anti-Infectives, today announced it has entered into an agreement with the Murdoch Children’s Research Institute (MCRI) to conduct preclinical studies assessing the potential of RECCE® 435 (R435) for the treatment of Helicobacter pylori (H. pylori) infections.
“Antibiotic-resistant forms of H. pylori are on the rise,” stated Recce Pharmaceuticals Non-Executive Chairman, Dr. John Prendergast. “This is worrisome because more than four billion worldwide are infected with H. pylori,1 which is the leading cause of peptic ulcers and stomach cancer. We are excited to collaborate with Professor Sutton and MCRI in investigating the potential of our oral antibiotic RECCE® 435 as what could be the first non-combination treatment for H. pylori infection, including those caused by drug resistant forms of the pathogen.”
The research program will be carried out by the Mucosal Immunology Group at the MCRI, Royal Children’s Hospital. The MCRI is the largest child health research institute in Australia and one of the top three worldwide for research quality and impact.2
Researchers will evaluate the antimicrobial activity of RECCE® 435 against H. pylori across a range of internationally recognized in-vitro and in-vivo study models. The studies will be led by Professor Philip Sutton, Head of MCRI Mucosal Immunology Group in Victoria, Australia. Professor Sutton recently joined Recce’s clinical advisory committee as Head of the H. pylori program with a world leading background in the biology of H. pylori and the subsequent infections linked to stomach ulcers and gastric cancer.
There is a global unmet medical need for the treatment of H. pylori with no first-line therapy curative in all patients.3 Today, the most commonly used treatment is triple therapy, which includes the use of a proton-pump inhibitor (PPI) in combination with multiple antibiotics (amoxicillin, metronidazole and/or clarithromycin).4 The existing treatment duration is 7 to 14 days; however, the eradication rate of standard triple therapy has fallen below 80% due to the increasing prevalence of antibiotic resistant strains worldwide.2
Recce and MCRI will work together on the oral antibiotic dosing program with a particular focus on optimal dosing and the effect of RECCE® 435. The agreement is in place until 31 December 2022; however, the Company anticipates completion in approximately 12 months, at which time it will pursue a human clinical trial. The Company is well funded to support the study program following its recent successful capital raise. All intellectual property rights are retained by the Company.
The World Health Organization (WHO) lists H. pylori as a priority pathogen on its list of antibiotic-resistant bacteria that pose the greatest threat to human health. An expert led panel at the WHO identified that there is an urgent need to develop new antibiotics against H. pylori, which remains a significant cause of morbidity and mortality worldwide. As a result, the U.S. Food and Drug Administration have included H. pylori as a bacterium qualifying for their Qualified Infectious Disease Product (QIDP) program. The estimated direct and indirect costs related to H. pylori and peptic ulcer disease is nearly $6 billion annually.5
About Recce Pharmaceuticals Ltd
Recce Pharmaceuticals Ltd (ASX: RCE) is pioneering the development and commercialisation of New Classes of Synthetic Anti-Infectives designed to address the urgent global health problems of antibiotic resistant superbugs and emerging viral pathogens.
Recce’s anti-infective pipeline is unique and comprised of broad-spectrum synthetic polymer antibiotics RECCE® 327 and RECCE® 435, and RECCE® 529 for viral infections with unique mechanisms of action against hyper-mutation on bacteria and viruses, respectively.
Patented lead candidate RECCE® 327 has been developed for the treatment of blood infections and sepsis derived from E. coli and S. aureus bacteria – including their superbug forms. Recce’s new antibiotic compound, RECCE® 435, has been formulated for oral use.
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.
Recce wholly owns its automated manufacturing, ready to support first-in-human clinical trials. Recce’s anti-infective pipeline seeks to exploit the unique capabilities of RECCE® technologies targeting synergistic, unmet medical needs.
Corporate Contact
James Graham
Recce Pharmaceuticals Ltd
+61 (02) 8075 4585
James.graham@recce.com.au
Media and Investor Relations (AU)
Andrew Geddes
CityPR
+61 (02) 9267 4511
ageddes@citypublicrelations.com.au
Media and Investor Relations (USA)
Meredith Sosulski, Ph.D.
LifeSci Communications
+1 929 469 3851
msosulski@lifescicomms.com
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1 https://www.gastrojournal.org/article/S0016-5085(17)35531-2/pdf
2 https://www.mcri.edu.au/about
3 https://www.racgp.org.au/afp/2014/may/helicobacter-pylori-eradication/
4 https://clinicaltrials.gov/ct2/show/NCT03832465
5 https://www.cdc.gov/mmwr/preview/mmwrhtml/00049679.htm