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MHRA approves Infex Therapeutics’s study for treatment for non-cystic fibrosis patients

The treatment, for Pseudomonas aeruginosa, will address a chronic and debilitating respiratory condition that has no approved available treatments

MHRA

Infex Therapeutics, a specialist in critical infectious diseases, has been given approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) to initiate a phase 1 study of its RESP-X programme.

RESP-X – in-licensed from Shionogi – is a new anti-virulence therapy to treat Pseudomonas aeruginosa (Pa) infections in non-cystic fibrosis bronchiectasis (NCFB) patients. NCFB is a chronic and debilitating respiratory condition with no approved available treatments.

NCFB causes an irreversible and progressive dilatation of bronchi as a result of chronic bronchial inflammation, and is characterised by periods of manageable disease, interspersed with flare-ups, which are also known as ‘exacerbations’. These episodes can increase in frequency and severity during patients’ lives.

The novel humanised monoclonal antibody has been created to address Pa infections, a hard-to-treat drug-resistant pathogen recognised by the WHO as a critical threat to human health.

Although it does not destroy the bacteria directly, it is able to deactivate one of its critical mechanisms, allowing the immune system to clear the body of infection.

The British Lung Foundation has estimated there are more than 30,000 NCFB patients in the UK.

NCFB flare-ups are similar to acute bacterial infections, with Pa marked as one of the leading causes.

In some of the most severe cases, patients can have multiple exacerbations each year, leading to high hospitalisation and mortality rates, which as the condition progresses, can present a serious financial burden for both patients and healthcare systems.

Infex expects the phase 1a/b clinical study to start in the second half of 2022 as a single centre, first-in-human, double-blind, placebo-controlled, intravenous single ascending dose study.

The trial will asses the safety, tolerability, pharmacokinetic, pharmacodynamic and immunogenicity of RESP-X in healthy patients and NCFB patients.

Dr Peter Jackson, CEO of Infex Therapeutics, said: “RESP-X is our first programme to enter the clinic and this is a significant milestone for the company. NCFB is a neglected, chronic condition that results in progressive respiratory decline and lung damage.

“These patients are seriously at risk of becoming chronically infected with Pseudomonas aeruginosa, a debilitating bacterial infection, impacting millions of patients worldwide, for which there are currently no approved treatments.”

Article by
Fleur Jeffries

16th May 2022

From: Regulatory, Healthcare

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