Recce Announces Positive Intranasal Animal Data against SARS-CoV-2 in International Study

Highlights:

• RECCE^® 327 and RECCE^® 529 demonstrated dose-dependent activity in-vivo against SARS-CoV-2 virus in Syrian golden hamsters, a well-accepted model of infection
• Intranasal administration of both compounds supports multiple potential modes of administration against SARS-CoV-2
• Company committed to its COVID-19 activities as part of its infectious disease portfolio

SYDNEY, Australia, Dec. 23, 2020 (GLOBE NEWSWIRE) — Recce Pharmaceuticals Ltd (ASX: RCE) (Company), the Company developing new classes of synthetic anti-infectives, today announced results from its international SARS-CoV-2 in-vivo studies, demonstrating positive activity of RECCE^® 327 (R327) and RECCE^® 529 (R529) against the SARS-CoV-2 virus in Syrian golden hamsters.

Non-Executive Chairman Dr. John Prendergast said, “We are certainly encouraged by these in-vivo results and will continue to investigate the potential of Recce’s anti-infectives in larger animal models. We look forward to continuing our international studies which demonstrate the potential of our compounds to be effective against SARS-CoV-2.”

The study consisted of five groups of eight hamsters, each receiving a different treatment – placebo control of saline nasal wash, low dose of R327 (200mg/kg), high dose of R327 (400mg/kg), low dose of R529 (100mg/kg), and high dose of R529 (200mg/kg). All animals were infected with SARS CoV-2 on Day 0 with treatments administered twice daily on Days 1-5 and viral titres measured directly on Days 2, 4 and 6 via qPCR. In this model, the viral titres typically peak between Days 2 and 4.

The results, in both R327 and R529, demonstrated a positive reduction in COVID-19 viral load compared to the placebo group. The data that statistical significance has not been assessed, conveyed a mean log reduction within groups on Day 4 where the low R529 dose achieved a log reduction in the order of 1.5 logs and a high dose of R327 achieved a log reduction of 1.25 logs. Two of the five hamsters with COVID-19 infection on Day 6 indicated adverse clinical symptoms in the high dose R529 group and were excluded from the study. The Company considers a study specific anomaly since R529 was routinely well tolerated at considerably higher intravascularly infused doses in–vivo. The weight of the hamsters across all groups at the start and the end of the study remained approximately the same.

This hamster study is the first indication of the potential for nasal administration of Recce’s anti-infective compounds, specifically when used against viruses. A gold-standard ferret COVID-19 study is underway in the United States seeking to build upon this method of administration, including higher dose concentrations and two other forms of administration, only possible in larger species. These data are expected in early 2021.

Whilst Recce is delighted by the results, further testing must be completed before R327 or R529 are confirmed as being safe or effective against the SARS-CoV-2 virus. The Company would like to thank IITRI for performing the experiments. IITRI is a “DOD-secure” facility; both the physical security of IITRI laboratories and our facility security program are regularly reviewed by inspectors from the United States Department of Defence¹.

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://iitri.org/iitri-advantage/

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

An infographic accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/2dc0c5c2-c07e-4452-987f-9ea8b86dbea8