Infex Therapeutics has dosed the first patients in a phase 1 study evaluating RESP-X, its lead anti-virulence candidate to treat Pseudomonas aeruginosa (Pa) infections in non-cystic fibrosis bronchiectasis (NCFB) patients, the anti-infectives specialist announced.
NCFB is defined by an irreversible and progressive dilatation of bronchi due to chronic bronchial inflammation. The disease is characterised by periods of stable disease, with flare-ups, which are also known as ‘exacerbations’, that increase in frequency and severity over the patient’s lifetime.
The British Lung Foundation has estimated there are more than 30,000 NCFB patients in the UK.
In most severe cases, patients have multiple exacerbations per year, resulting in high hospitalisation and mortality rates.
Pa is a hard-to-treat drug-resistant pathogen recognised by the World Health Organization as a ‘critical threat’ to human health, the company reported, and is a leading cause of NCFB exacerbations. There are currently no approved preventative treatments for Pa infection.
RESP-X, in-licensed from Shionogi, is a novel humanised monoclonal antibody designed to help the body tackle Pa infections by deactivating a critical virulence mechanism and enabling the patient’s own immune system to clear the infection.
The phase 1 study, which is being conducted at National Institute for Health and Care Research (NIHR) Liverpool Clinical Research Facility, is a 32 subject, single centre, first-in-human, double-blind, placebo-controlled, single ascending dose study, administered intravenously to cohorts of healthy volunteers.
It will evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic and immunogenicity profile of RESP-X in healthy subjects.
Top line results from the study are expected to be available in the first half of 2023, the company said, and will be used to inform further clinical trials in NCFB patients to reduce the frequency and severity of Pa–mediated exacerbations.
Dr Peter Jackson, executive director of Infex, said the start of the study was a “significant milestone” for the company, marking its transition from a preclinical to a clinical stage biotech.
He continued: “RESP-X has huge potential to improve the outcomes for millions of patients worldwide who suffer from Pa colonised NCFB, a chronic and debilitating condition for which there are currently no approved preventative treatments.”
Dr Richard Fitzgerald, director of the NIHR Liverpool Clinical Research Facility, said: “There is a desperate need for new treatment options in the escalating fight against antimicrobial resistance, which is a serious and growing concern for global healthcare systems.”