First subject dosed in Phase I study to evaluate safety and tolerability of RESP-X in healthy volunteers
Significant milestone, marking Infex’s transition to a clinical stage company

Alderley Park, Cheshire, U.K. Infex Therapeutics, a leading anti-infectives specialist, is pleased to announce the first subjects have been dosed in Phase I study in healthy volunteers evaluating the Company’s lead drug candidate RESP-X, a new anti-virulence therapy to treat Pseudomonas aeruginosa (Pa) infections in non-cystic fibrosis bronchiectasis (NCFB) patients. Pa is a critical factor in this chronic and debilitating respiratory disease leading to recurring severe episodes of life-threatening infection, for which there are currently no approved preventative treatments.

The Phase I study 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 Phase I study are expected to be available in H1 2023 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 Therapeutics, said: “The start of the Phase I study for our RESP-X programme is a significant milestone for Infex, marking our transition from a preclinical to a clinical stage biotechnology company. The study will assess the safety and tolerability of RESP-X in a cohort of healthy volunteers and will inform the dosing in the subsequent trials with NCFB patients. 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.”

The study, which is being conducted at NIHR Liverpool Clinical Research Facility, part of the Liverpool University Hospital, is the culmination of a work programme supported by a £2m grant awarded by the Infection Innovation Consortium (iiCON), a world-leading centre for infection innovation and R&D.

Professor 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. We are delighted to be working with Infex to leverage our experience and expertise in early-stage clinical trials to progress the clinical development of RESP-X, a promising and important new treatment option against Pa, a devastating WHO critical-priority infectious disease, which impacts millions of patients around the world.”

About RESP-X
In-licensed from Japanese pharma company Shionogi, RESP-X is a novel humanised monoclonal antibody designed to help the body tackle Pa infections, a hard-to-treat, drug-resistant pathogen recognised by the WHO as a critical threat to human health. It does not kill the bacteria directly but deactivates a critical virulence mechanism, enabling the patient’s own immune system to clear the infection.

NCFB is a disease defined by an irreversible and progressive dilatation of bronchi due to chronic bronchial inflammation. It is characterised by periods of stable disease, with flare-ups, known as “exacerbations”, that increase in frequency and severity over the patient’s lifetime. There are at least eight million NCFB patients in major markets, of which around 30% have chronic Pa colonisation. In the UK, the British Lung Foundation estimates there are in excess of 30,000 NCFB patients.

NCFB exacerbations are closely associated with acute bacterial infections, with Pa being one of the leading causes. In most severe cases, patients have multiple exacerbations per year, resulting in high hospitalisation and mortality rates. As the disease progresses there are serious economic impacts for patients and healthcare systems.