Recce Pharmaceuticals Enters Agreement with Path BioAnalytics to Test RECCE® Compounds in Expanded SARS-CoV-2 Program

Highlights:

• International study will be conducted in a laboratory at a leading academic institution in the U.S. to evaluate anti-viral activity of RECCE® 327 and new antiviral formulation RECCE® 529
• Expanded program utilizing Centers for Disease Control (CDC) SARS-CoV-2 clinical isolate SARS-Related Coronavirus 2, Isolate USA-WA1/2020
• Preliminary data anticipated September 2020

SYDNEY, Australia, July 16, 2020 (GLOBE NEWSWIRE) -- Recce Pharmaceuticals Ltd (ASX: RCE) (Company), the company developing new classes of synthetic anti-infectives, today announced it has entered into an agreement with Path BioAnalytics Inc. (PBA), a precision medicine company based in Durham, N.C., USA, to study RECCE® 327 and RECCE® 529 against SARS- CoV-2. RECCE® 327 is a broad-spectrum synthetic antibiotic formulated using synthetic polymer technology to treat blood infections and sepsis. RECCE® 529 is a new synthetic polymer formulation, built upon the Company’s anti-infective expertise.

“The current pandemic underscores the need for more effective treatment approaches to prevent infectious diseases,” said Dr. John Prendergast, Recce Pharmaceuticals Non-Executive Chairman. “Over the past few months Recce has received a number of inquests from several universities and research organizations to collaborate on the development of potential new therapies to address the unmet needs of patients with COVID-19. We’re excited to be working with experts at Path BioAnalytics to investigate the potential effectiveness of Recce’s compounds in treatment of SARS-CoV-2 infection using their advanced respiratory organoid model system.”

Researchers at PBA will evaluate RECCE® 327 and RECCE® 529 against SARS-CoV-2 (the virus causing the disease ‘Coronavirus’ or ‘COVID-19’¹) in an ex vivo respiratory organoid model system.

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The study will be conducted in the state-of-the-art Biosafety Level 3 containment laboratories of a leading U.S. research university, where the infection of the organoids with SARS-CoV-2 will take place. The purpose of the study is to evaluate both compound therapies for the prevention and/or mitigation of SARS-CoV-2 infections in an ex-vivo respiratory model system with preliminary data anticipated in September 2020.

All intellectual properties are retained by the Company. Following selection for a domestic program as previously announced, the antiviral potential of Recce’s compounds is now being tested independently in the U.S. and Australia.

Path BioAnalytics is a precision medicine company dedicated to the advancement of next- generation treatments for diseases with high unmet need. PBA is currently focused on using its industry-leading respiratory organoid technology to evaluate SARS-CoV-2 targeted treatments on behalf of pharmaceutical and biotechnology companies worldwide. The company’s respiratory organoids are pseudo-stratified, differentiated 3D cell cultures derived from primary respiratory cells that replicate the airway physiology and are amenable to SARS- CoV-2 infection. Unlike commonly used model systems, PBA organoid technology does not place selective pressure on viruses, thus maintaining an accurate representation of viral infection.

While Recce is delighted that its compounds have been selected for potential investigational therapies, such selection is not an indication that the compounds are safe or effective for use in treatment of SARS-CoV-2.

About Recce Pharmaceuticals Ltd

Recce Pharmaceuticals Ltd (ASX: RCE) is pioneering the development and commercialization of new classes of synthetic anti-infectives designed to address the urgent global health problems of antibiotic resistant superbugs and emerging viral pathogens.

Recce antibiotics are unique – their potency does not diminish even with repeated use, a common failure associated with existing antibiotics and their propensity to rapidly succumb to resistant superbugs.

Patented lead candidate RECCE® 327, wholly owned and manufactured in Australia, has been developed for the treatment of blood infections and sepsis derived from E. coli and S. aureus bacteria – including their superbug forms.

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.