Over the last six months, Recce Pharmaceuticals Ltd (ASX: RCE) has experienced a notable surge in its share price, climbing nearly 50%, as the company advances its innovative treatments through significant clinical milestones, gaining substantial backing from the US Department of Defence as well.
The company is at the forefront of developing a new class of synthetic anti-infectives aimed at combating the global health crisis posed by antibiotic-resistant superbugs.
Recce's shares are currently trading at A$0.66 apiece, reflecting a market capitalisation of A$134.6 million.
Figure 1: Share price chart (Source: ASX)
Clinical milestones propel growth
Recce has made considerable progress in its clinical programs, notably in its UTI/Urosepsis Phase I/II trial, which showed promising minimum inhibitory concentration (MIC) activity (Figure 2).
The trial is poised to advance to the next dosage increase shortly.
Meanwhile, the company's Diabetic Foot Infection (DFI) clinical trial has also reached a new phase.
After demonstrating treatment efficacy, the trial is set to expand into a Phase III registrational trial in Indonesia, scheduled to kick off in the September quarter of this year.
Figure 2: Recce’s pipeline (Source: RCE Website)
Extensive pathogen resistance testing
In a strategic collaboration with Linnaeus Bioscience, Recce is testing flagship RECCE® 327 (R327) against over 300 pathogen strains across the ESKAPEE group, which includes 198 Gram-negative and 111 Gram-positive bacteria strains.
Hannah Tsunemoto PhD, Chief Operations Officer at Linnaeus, led the testing and confirmed, “R327 is effective against all strains tested at MICs.” This includes strains clinically isolated from diverse sources such as wounds, blood, urine, and sputum.
In further studies, R327 demonstrated no induced resistance when tested against a Multi-Drug Resistant (MDR) strain of Escherichia coli over 31 days, highlighting its robust anti-resistance properties.
Support from the US Department of Defence
A significant endorsement of Recce's treatment platform came from the US Department of Defence, which recommended RECCE® 327 Gel (R327G) as a topical treatment for Burn Wound Infections, with proposed grant funding amounting to US$2.2 million (approximately A$3.34 million).
This support underscores the potential of Recce's products in addressing critical medical needs.
Looking ahead, Recce plans to submit an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) in the latter half of 2024, following promising data from its ongoing clinical trials.
Gaining international recognition
Recce has also recently achieved international acclaim, having presented at significant events such as the Biomedical Advanced Research and Development Authority (BARDA) and the World AMR Congress 2024.
The company received sponsorships from both the Western Australian and New South Wales governments for its participation in the BIO International Convention 2024.
Scaling production to meet demand
This month, Recce enhanced its production capabilities, successfully manufacturing 5,000 doses weekly of RECCE® 327 under Good Manufacturing Practice (GMP) standards.
This scale-up was facilitated by temporarily relocating manufacturing equipment to a third-party cleanroom-GMP facility. Arthur Kollaras, Recce’s head of manufacturing, expressed his enthusiasm: "We are thrilled to announce the successful batch completion of human pharmaceutical grade R327, representing a crucial step forward in our mission to address the global threat of antimicrobial resistance."
The GMP certification, which covers all aspects of production, is vital in ensuring the consistent quality of the medicine, crucial for patient safety and treatment efficacy.
Universal mechanism of action
Recce’s anti-infectives exhibit a universal mechanism of action that maintains their efficacy even against hyper-cellular mutations of bacteria and viruses, addressing a critical gap in current treatment options.
The company continues to advance its clinical programs and expand its product pipeline, the company is well-positioned to meet the increasing global demand for effective treatments against 'difficult to treat' bacterial infections, including those resistant to traditional antibiotics.
This trajectory not only enhances its market presence but also solidifies its role in shaping the future of anti-infective therapies.
About the company
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.
Its anti-infective pipeline includes three patented, broad-spectrum, synthetic polymer anti-infectives:
RECCE® 327 is 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 is 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.
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