Recce Pharma reports positive data from anti-viral drug trial for Influenza A, signs agreement for first-in-human study

Recce Pharmaceuticals ASX RCE positive in vivo anti-viral activity Influenza A virus
Recce has released positive efficacy data showing significant in vivo anti-viral activity against the Influenza A virus in mice treated with its lead compound RECCE 327.

A study into a new class of synthetic antibiotics developed by Recce Pharmaceuticals (ASX: RCE) has produced positive data showing significant in vivo anti-viral activity against the Influenza A virus in mice being treated with the company’s patented lead compound Recce 327.

Data from the study involving four groups of 12 mice infected with Influenza A showed a significant dose-dependent decrease in the viral growth rate and viral load in lungs of mice infected with the virus following treatment with the compound.

This compared to a vehicle control untreated group and a third group treated with approved anti-viral drug Ribavirin, which decreases relapse rates by accelerating viral clearance in the early stages of treatment.

The Recce 327 treatment group was dosed twice daily for five days and the Ribavirin treatment group was dosed once a day over the same period.

Viral pathogenesis in the mice was evaluated by body weight loss, survival and viral load in lungs.

According to the company’s findings, Recce 327 showed efficacy at different dose levels with a significant reduction in viral count in the lungs when compared with the vehicle control group.

As the dosage increased from 500 milligrams per kilogram to 1000mg/kg, the viral count fell below the limit of quantitation (BLOQ) on days four and six post-infection.

Mechanism of action

Recce non-executive chairman Dr John Prendergast said the data reinforced the antibiotic’s universal mechanism of action, which provides continued potency even after repeated use.

“The increasing potential to be effective against not only a broad range of superbug bacteria, but viral pathogens as well, reinforces the company’s expanding infectious disease capabilities and global positioning,” he said.

Influenza A is an enveloped virus and causative agent of respiratory disease.

The genome of the virus comprises single-stranded ribonucleic acid molecules similar to that of coronaviruses.

Superbug treatment

Recce antibiotics are considered unique in that their potency does not diminish even with repeated use, which is reported to be a common failure associated with existing antibiotics and the emergence of resistant superbugs.

The company’s lead candidate Recce 327 is a broad-spectrum antibiotic employing synthetic polymer technology and developed for the treatment of blood infections and sepsis derived from Escherichia coli and Staphylococcus aureus bacteria, including their superbug forms.

Sepsis is a potentially life-threatening condition caused by bacterial infection in the blood and sees the immune system mount a hyperactive inflammatory response, which can quickly lead to tissue and organ injury and ultimately, death.

There are currently no drug therapies available which specifically treat sepsis and Dr Prendergast said there exists a “desperate and unmet medical need for new, safe and efficacious treatments”.

In February, Recce reported in-vivo toxicity (safety) studies conducted by an independent research laboratory on small and large animal species further reinforced indications of a wide therapeutic window for Recce 327.

Human trials

Earlier this month, Recce announced it had formalised a Phase I clinical trial agreement to conduct a first-in-human study of Recce 327 on 40 healthy patients.

The randomised, double blind, placebo-controlled, single-ascending dose study will evaluate the drug’s safety, tolerability, pharmacokinetic and pharmacodynamic properties with clinical start-to-completion expected within 12 months.

“This agreement is a major milestone towards advancing Recce 327 through the clinic,” Dr Prendergast said.

“It brings us a step closer to addressing the rising rates of antibiotic resistance, with a synthetic antibiotic which has shown extraordinary preclinical potential to fight off a broad range of bacterial infections, including superbug forms, even with repeated use,” he said.

At midday, shares in Recce Pharmaceutical were trading 18.46% higher at $0.39.

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