Recce Pharmaceuticals Announces Encouraging Results from Anti-viral Screening Program at The Doherty Institute Evaluating RECCE® 327 Against SARS-CoV-2

Highlights:

• RECCE^® 327, a synthetic anti-infective 99.9% efficacious in confirmatory in-vitro screening assay against SARS-CoV-2 virus
• SARS-CoV-2 virus no longer detectable by virus titration at 4,000 ppm – minimal toxicity to Vero cells
• No toxicity identifiable at 1,333 ppm or less
• U.S. in-vivo studies in parallel expanded to include new UK & South African COVID-19 causing strains

SYDNEY, Australia, Feb. 16, 2021 (GLOBE NEWSWIRE) — Recce Pharmaceuticals Ltd (ASX: RCE) (Company), the Company developing new classes of synthetic anti-infectives, today announced results of RECCE^® 327 (R327) demonstrating encouraging virucidal activity against the SARS-CoV-2 virus with a positive safety profile.

“We continue to be encouraged by the results from the antiviral SARS-CoV-2 screening program as it reinforces our belief in the potential of R327 against COVID-19 including emerging variant strains,” said Non-Executive Chairman Dr. John Prendergast. “We would like to thank the Doherty Institute for performing the experiments and look forward to coming studies.”

The finding is based on independent tests conducted by the CSIRO/Doherty Institute as part of its SARS-CoV-2 Anti-viral Screening Program.

R327 showed a reduction in SARS-CoV-2 viral genome numbers at 4,000 parts per million (ppm) and virus was no longer detectable by viral titration; the RT-PCR detected the three-log drop in viral genome copies (99.9% reduction). PCR is a highly sensitive technique for viral detection and quantitation – the first choice in COVID swab testing in humans and animals.¹ Antiviral testing was conducted in triplicate with a very small variance bar above the 4,000 ppm data point. Minimal toxicity was observed at 4,000 ppm of R327; there was no cytotoxicity at or below 1,333 ppm.

Further testing will be required at higher dose levels to establish the IC 50 and cytotoxicity which will then allow the Company to decide whether to pursue R327 as an anti SARS-CoV2 inhibitor candidate. Statistical signficance was not relevent in this study. All intellectual property rights are retained by the Company with data to be reported as becomes available.

In parallel to the testing at CSIRO/Doherty Institute in Australia, a leading contract research organisation in the United States is expanding its in-vivo studies of RECCE compounds against SARS-CoV-2 in ferrets to include emerging UK and South African variant strains of the virus. These studies continue to progress well with results on-track within the present quarter.

Whilst Recce is delighted by the results, further testing must be completed before R327 is confirmed as being active against the SARS-CoV-2 virus.

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.

¹ https://pubmed.ncbi.nlm.nih.gov/21819328/ 

Chief Executive Officer
James Graham
Recce Pharmaceuticals Ltd
+61 (02) 9256 2571
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, PhD
LifeSci Communications
+1 929 469 3851
msosulski@lifescicomms.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/e8623e3f-66ef-4446-bfa8-c0647d01c775.