Communicators

Highlights:

-          Strong cash position of $20.87 million

-          Topical Phase I/II Clinical Trial began and was registered on Australia New Zealand Clinical Trial Registry

-          R327 Sinusitis efficacy in Special Access Scheme Category A human case

-          >99.9% effective against full suite of ESKAPE pathogens – only known antibiotic in clinical development efficacious against all ESKAPE pathogens

-          R327 advances to Stage 2 in Australian government SARS-CoV-2 Program

-          R327 – Demonstrates World First Multiple Mechanisms of Action

SYDNEY Australia, 30 July 2021: Recce Pharmaceuticals Ltd (ASX:RCE, FSE:R9Q), the Company developing New Classes of Synthetic Anti-infectives, today released its June 2021 quarter results and operational highlights.

Financial Update

The Company ended the quarter with a cash balance of $20.87 million. Net cash out-flows were ($1.99 million), significantly offset by R&D rebates, grants and other state/federal initiatives. Research and Development ($1.03 million) was the largest item of expenditure. Payments to related parties (Executive & Director fees) was ($0.342 million).

Operational Highlights

Topical Phase I/II Clinical Trial began and was registered on Australia New Zealand Clinical Trial Registry

Phase I/II Topical Burns Study in Humans was registered on the Australia New Zealand Clinical Trials Registry (ANZCTR) under the trial ID ACTRN12621000412831: ‘Proof of Concept Study of RECCE 327 Topical Antibiotic Therapy for Infected Burn Wounds in Adults’.

Sinusitis Study Activity (in-vivo)

The Company announced positive sinusitis animal study data against the Gram-positive bacterium Streptococcus pneumoniae (S. pneumoniae). The study was conducted by an independent Contract Research Organisation, to assess dose-dependency of RECCE compounds in-vivo against S. pneumoniae in a mouse model of acute bacterial rhinosinusitis infection.

Special Access Scheme Category A – A Patients Journey

Building on in-vivo safety & efficacy, the Company reported a positive human clinical response in a patient following dosing of R327, via nasal passage, against multi drug resistant, Gram-negative Pseudomonas aeruginosa (P. aeruginosa) pursuant to the Therapeutic Goods Administration Special Access Scheme - Category A (SAS - Category A).

R327 is not market approved for use in humans. Further clinical testing is required to evaluate safety and efficacy.

An ESKAPE Pathogen Company

R327 repeatedly achieved a >99.9% bacterial reduction against the full suite of ESKAPE pathogens, within hours of exposure. R327’s Broad Spectrum antibiotic showed uniquely comparable efficacy against the hypermutated ESKAPE superbugs, including Multi-Drug Resistant forms – a current market challenge of all existing antibiotics.

R327 was further tested against two WHO global priority pathogens carbapenem resistant Escherichia coli (E. coli CRE) and multi drug resistant Neisseria gonorrhoeae (N. gonorrhoea MDR), demonstrating similarly high levels of efficacy.

The Company is the only known antibiotic in clinical development efficacious against all ESKAPE pathogens globally.

SARS-CoV-2

The Company further advances its SARS-CoV-2 studies, completing Stage 1B and receiving a qualified recommendation to advance to Stage 2 of the Program for further testing at a government research institution. Stage 1B supported and extended findings of its previous Australian SARS-CoV-2 studies and allowed the half maximal inhibitory concentration (IC50) of 2,046ppm and cytotoxicity (CC50) of 5,108ppm of R327 to be determined.

Further testing must be completed to determine whether R327 will show an inhibitory effect against the SARS-CoV-2 virus without associated toxicity.

World First Multiple Mechanisms of Action

The quarter saw the Company announce further insight into R327’s Mechanism of Action (MoA). The MoA was found to be ‘unlike that of any antibiotic seen before’ with multiple mechanisms identified in independent study.

The study was performed by independent, world leaders in bacterial Mechanism of Action analysis and antibiotic profiling.

Key takeaways from the study were as follows:

-          R327 rapidly and irreversibly shuts down cellar energetics (ATP production) – primary MoA

-          R327 affects the assembly of bacterial cell division complex, components that require cellular energy to remain assembled, confirming its ability to disrupt cellular bioenergetics

-          R327 results in the decreased formation of the bacterial cell division complex into ring-like structures (Z-rings) in a concentration dependent manner

-          R327 permeabilizes the cell membrane or alter the integrity of the outer membrane of E. coli cells – intended activity without toxicity

-          At higher concentrations and subsequent to ATP shut down cell lysis (bacterial bursting due to their uniquely high internal pressures) can occur as a further mechanism of action

-          R327 rapidly and irreversibly bactericidal to slow-growing, quiescent or stationary phase E. coli cells in addition to actively dividing E. coli cells

-          Within a minute, the highest concentration of R327 used, 5x minimum inhibitory concentration (MIC), was observed to reduce viable cell counts reported as cell forming units per millilitre of culture (CFU/ml) 100-fold (>1x107 to 1x105 at timepoint 0)

-          Current antibiotics rarely retain bactericidal activities against nondividing or stationary phase bacterial cells; however, R327 showed remarkable activity against slow-growing bacteria thereby indicating potential antibacterial activity in biofilms

-          In comparison to ampicillin and ciprofloxacin, R327 is able to outperform both of these antibiotics in bactericidal activity (as measured by viable cell counts) against stationary cells

These findings, elucidating R327’s MoA, saw acceptance of invitation to present at the World Microbe Forum following confirmation to publish an Abstract in the 2021 program. The presentation was in the format of an iposter (digital poster).

Looking Ahead

The Company would like to thank its shareholders and wider network for their ongoing support. Throughout the ongoing pandemic, Recce maintains its focus on maximising the potential of their therapeutic compounds to address the global unmet medical need of antibiotic resistance and emerging viral pathogens. 

With a strong cash position and increasingly positive data, the Company is well placed to continue to deliver on its globally relevant objectives over the time ahead.

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

About Recce Pharmaceuticals Ltd

Recce Pharmaceuticals Ltd (ASX: RCE, FSE: R9Q) 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, 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 as an intravenous therapy, is being developed for treatment of serious and potentially life-threatening infections including sepsis due to Gram-positive and Gram-negative 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. Further to this designation, RECCE® 327 has been included on The Pew Charitable Trusts Global New Antibiotics in Development Pipeline as the only synthetic polymer and sepsis drug candidate in development.

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.