- Promising Minimum Inhibitory Concentration (MIC) activity in Phase I/II trial for urinary tract infections (UTI) and urosepsis with an increase in dosage expected to begin in the next several weeks
- Expansion of Phase I/II trial for diabetic foot infections (DFI) with efficacy achieved and now moving towards the initiation of a Phase III registrational trial in
Indonesia scheduled to commence in Q3 2024 - RECCE® 327 (R327) shown to be effective against more than 300 strains of bacterial pathogens during testing with Linnaeus Bioscience
U.S. Department of Defense has recommended RECCE® 327 Gel (R327G) as a topical treatment for burn wound infections for grant funding of$2.2 million - Submission of Investigational New Drug (IND) application with the
U.S. FDA expected in H2 2024 forU.S. trial initiation in H1 2025 - Continued recognition and awareness of Recce with presentations recently presented at the
Biomedical Advanced Research and Development Authority (BARDA), opening keynote address and opening R&D address at theWorld AMR Congress 2024 and sponsorship received fromWestern Australia (WA) andNew South Wales (NSW) government for theBIO International Convention 2024
Detailed Update:
Progress of R327 across Multiple Indications
(UTI/Urosepsis, DFI, Topical Wounds, SAS-A)
Phase I/II UTI/Urosepsis Trial – R327 Achieving Minimum Inhibitory Concentration (MIC)
The Company is making significant strides in its Phase I/II trial for UTIs and urosepsis. Recent clinical urine samples have indicated promising MIC activity, suggesting that fast infusion of R327 leads to concentrations capable of blocking the growth of bacteria in urine, which is relevant for the treatment of patients with UTIs and urosepsis, in a safe and tolerable manner. This promising finding has prompted the Company to increase the dosage of R327 in this Phase I/II trial to its highest level yet, at a rate of 4,000mg infused over 30 minutes, which is expected to begin by the end of Q2 2024. This escalation reflects the significant progress surrounding R327's potential to address critical medical needs in the treatment of UTIs and urosepsis.
DFI Efficacy Achieved: Expansion of Phase I/II DFI Clinical Trial
Recce is actively pursuing an expansion of its clinical trial sites for its Phase I/II trial evaluating R327 in patients with DFIs, with notable sites identified and expected to come online during the present quarter, including one of the largest and most comprehensive regional health services in
This strategic initiative aims to access a greater patient population, enhancing the diversity and depth of clinical data gathered. By forging collaborations with these esteemed institutions, the Company continues to demonstrate its commitment to advancing medical research and delivering innovative solutions that could potentially transform patient outcomes.
The Company is actively advancing its latest international expansion in
R327 works and keeps on working with repeated use: tested in more than 300 Strains of Bacterial Pathogens – Effective Against All
The Company continues to work with leading experts dedicated to the discovery and development of innovative technologies, Linnaeus Bioscience, where they have tested R327 against more than 300 strains between the ESKAPE group of pathogens (198 Gram-negative and 111 Gram-positive bacteria strains). Chief Operations Officer of Linnaeus,
Gram-positive representatives | Gram-negative representatives | |||
Bacteria | Strains | Bacteria | Strains | |
Enterococcus spp. | 33 | K. pneumoniae | 38 | |
S. aureus | 65 | A. baumannii | 53 | |
Enterobacter spp. | 13 | P. aeruginosa | 63 | |
Salmonella | 4 | |||
Total | 198 | E. coli | 40 | |
Total | 111 | |||
More than 95% of the strains tested were clinically isolated from a variety of sources, including but not limited to wounds, blood, urine, and sputum (phlegm).
Furthermore, in a 31-day sub-MIC serial exposure study, R327 was tested against a Multi-Drug Resistant (MDR) strain of Escherichia coli (E. coli) and showed no evidence of induced resistance to R327.
Submission of Investigational New Drug (IND) Application with the
The Company has been making significant strides in preparing for an investigational new drug (IND) application with the
As the Company continues to generate promising interim data from its Phase I/II UTI/Urosepsis clinical trial on both safety and efficacy, R327 is showcasing its capability to be administered over multiple fast infusion times, highlighting the potential for a ground-breaking treatment on the first patient presentation in any medical setting. These achievements collectively position Recce on track with its upcoming IND application, underscoring the company's dedication to bringing novel therapies to market swiftly and responsibly.
The Company expects to open a second IND application for all topical work conducted soon after the intravenous (IV)
Government/Private Enterprise Partnerships and Presence in the
Recce has been actively pursuing various grant applications and submissions, particularly in government antimicrobial resistance (AMR) initiatives and military and health security.
As a result of the Company's efforts in the military sector, the
Once awarded, the funding will enable the Company to accelerate the development and evaluation of R327G and evaluate it as a gel-based treatment to rapidly resolve burn wound infections and minimize the onset of bacteremia complications, such as sepsis. This milestone emphasizes the Company’s significant contributions to military health research. Recce expects funding to be received in H1 2024.
Recce delivered a company presentation at the request of the
BARDA has specific areas of interest that it focuses on for funding, where R327 fits into two categories: Antimicrobials (3.1 Multi-drug resistant Bacteria and Biothreat Pathogens) and Burn and Blast Medical Countermeasures (6.4 Non-Autologous Topical Products for Acute bacterial skin and skin structure infections). The presentation was well received and attended by members of the
WA and NSW Government Sponsor Recce for
The Company has received another prestigious invitation to present the opening R&D address at the
Poster Presentation -
Military Health System Research Symposium (MHSRS) Abstract Submission
As was delivered in 2023, the Company has again submitted an abstract for MHSRS 2024, building on its successful participation in 2023 and anticipating further success this year. The MHSRS is the
Additional Operational Activities
World Health Organization Recognition
R327, along with R435 and R529, gained recognition from the
This acknowledgment highlights the potential of RECCE® compounds to address critical global health challenges posed by antibiotic-resistant bacteria. Being included in the
R&D Advance Initiatives –
The Company continues to strengthen its strategic partnership with
For more insights into this partnership, Recce and Endpoints have released an on-camera podcast interview that discusses the influence of their collaboration on Recce's growth and the biotech industry, which can be accessed here.
About
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.
Corporate Contact
+61 (02) 9256 2571
James.graham@recce.com.au
Media & Investor Relations (AU)
CityPR
+61 (02) 9267 4511
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Source:
2024 GlobeNewswire, Inc., source