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Recce Awarded AusIndustry Advanced Overseas (R&D) Finding for Synthetic Anti-Infective Development Program

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Positive Data from Murdoch Children’s Research Institute Against Neisseria gonorrhoeae in Animal Model

Sydney Australia, 14 December 2023: Recce Pharmaceuticals Ltd (ASX: RCE), the Company developing a New Class of Synthetic Anti-Infectives, is pleased to announce the Australian Government has Awarded an Advanced Overseas Finding for AU$43,774,907 of Synthetic Antibiotic Research & Development (R&D) applicable expenditure by AusIndustry (a division of the Australian Government’s Department of Industry, Innovation and Science).

The Advanced Overseas Finding is one of the largest awarded in Australian history as a pillar of the R&D Tax Incentive Program administered by the Australian Government. This Finding does not constitute a grant, or an upfront payment of the amount awarded. It is a binding, underwritten guarantee provided by the Australian Government, which affirms the Company’s R&D activities are of national interest and extends the 43.5% R&D rebate from locally, to cover those undertaken by the Company anywhere in the world.

The Australian Government hereby extends the R&D cash rebate to the Company capturing its local and overseas R&D activities, for a period of three years (1 July 2022 to 30 June 2025). With Recce’s anti-infective program predominantly focused on Synthetic Antibiotic Development, the Advanced Overseas Finding award will support the Company’s cash position, in addition to the recent AUD $11,000,000 capital raise and is received by the Company as caveat-free, non-dilutive cash when claimed or drawn proportionately against through R&D funding facilities.

Recce Pharmaceuticals CEO James Graham said: “We would like to express our gratitude to AusIndustry and the Department of Industry, Innovation, and Science for their ongoing crucial support in advancing science and its practical applications, particularly in the development of innovative therapies with a global impact. This development is a further endorsement of the Company’s growth potential and secures our caveat-free R&D funding long-term.”

Positive Data from Murdoch Children’s Research Institute Against Neisseria gonorrhoeae in Animal Model

Highlights:

-          RECCE® 327 again demonstrates significant bactericidal activity against deadly Neisseria gonorrhoeae (N. gonorrhoeae) pathogen – 4-log (99.99%) and 3.5-log (>99.9%) reduction

-          Previous independently conducted study on N. gonorrhoeae supports results received from Murdoch Children’s Research Institute

-          N. gonorrhoeae listed as a priority pathogen on World Health Organisation’s list of bacteria that poses greatest threat to human health

Moreover, Recce Pharmaceuticals Ltd is pleased to announce positive efficacy of RECCE® 327 (R327) showing significant antibacterial activity against Neisseria gonorrhoeae (N. gonorrhoeae). The study was conducted by Murdoch Children’s Research Institute to test the efficacy of R327 treatment against N. gonorrhoeae in a mouse vaginal infection model.

Groups of 10 mice were inoculated vaginally with N. gonorrhoeae. R327 was administered twice daily as IV bolus dose of 1,000mg/kg and after three days, the mice treated with R327 showed an approximate 4-log reduction (99.99% reduction) in bacterial shedding – significant bactericidal activity. After five days of treatment, R327 showed a 3.5-log reduction (>99.9% reduction) in bacterial shedding compared to the placebo-treated group.

By the end of the treatment period, R327 was successful in significantly reducing vaginal gonococcal shedding, a study where a two-log reduction – equivalent to 99% reduction in bacterial burden - is commonly considered as of significant effect. The mice in this study displayed no clinical signs of gonococcal infection.

In a previous gonorrhoea STD animal model study conducted by an independent contract research organisation, R327 showed significant dose-dependent antibacterial effect in vaginal load at 100, 500 and 1,000 mg/kg given by intravenous (I.V.) bolus for 7 days (twice daily) when compared to the vehicle infected control group seven days post-infection. The recognised vaginal infection model met its primary endpoint of a reduction in bacterial load compared to vehicle-infected control evaluated on the seventh day following dosing.

Efficacy of RECCE  327 Against N. gonorrhoeae in Mice

I.V. administration, as was used in these studies, further emphasises the systemic potential to treat wide-ranging bacterial infections. A late-stage preclinical study comparing I.V. administration vs a topical application (gel & spray R327) against N. gonorrhoeae is underway. R327 has demonstrated positive safety and tolerability in respective human clinical studies that would support if pre-clinicals are successful, to enter a Phase II study.

Antimicrobial resistance to gonorrhoea is a serious and growing problem, rendering many classes of antibiotics ineffective with the risk of becoming untreatable.[1] Current treatment involves combination therapy using at least two antibiotics (ceftriaxone and azithromycin); however, bacterial resistance has recently led to restriction for infections caused by resistant organisms.

The World Health Organisation (WHO) has recognised gonorrhoea as a significant public health problem and is on the rise worldwide, with strains resistant to many antibiotics emerging. In 2020, WHO estimated 82.4 million new infections with N. gonorrhoeae among adults aged 15 to 49 years.

James Graham, Chief Executive Officer of Recce Pharmaceuticals Ltd said, “The need for a new class of anti-infectives could not be greater, especially against a lethal pathogen such as N. gonorrhoeae. The data from this study, along with the previous findings, emphasise the capability of R327 to demonstrate broad spectrum activity against antibiotic-resistant bacteria, even with repeated use.”

This announcement has been approved for release by Recce Pharmaceuticals Board.

About Recce Pharmaceuticals Ltd

Recce Pharmaceuticals Ltd (ASX: RCE, FSE: R9Q) is developing a New Class 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 includes three patented, broad-spectrum, synthetic polymer anti-infectives: RECCE® 327 as an intravenous and topical therapy that is being developed for the treatment of serious and potentially life-threatening infections due to Gram-positive and Gram-negative bacteria including their superbug forms; RECCE® 435 as an orally administered therapy for bacterial infections; and RECCE® 529 for viral infections. Through their multi-layered mechanisms of action, Recce’s anti-infectives have the potential to overcome the hypercellular mutation of bacteria and viruses – the challenge of all existing antibiotics to date.

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. Further to this designation, RECCE® 327 has been included on The Pew Charitable Trusts Global New Antibiotics in Development Pipeline as the world’s only synthetic polymer and sepsis drug candidate in development. RECCE® 327 is not yet market approved for use in humans with further clinical testing required to fully evaluate safety and efficacy.

Recce wholly owns its automated manufacturing, which is supporting present clinical trials. Recce’s anti-infective pipeline seeks to exploit the unique capabilities of its technologies targeting synergistic, unmet medical needs.

[1] https://www.who.int/news-room/fact-sheets/detail/gonorrhoea-(neisseria-gonorrhoeae-infection)