Phase 1 research will evaluate the tolerability and safety of therapy among healthy volunteers.
Infex – a company focusing on anti-infectives specialist – has announced that the first patients have been dosed in its phase 1 study researching candidate RESP-X.
The treatment is 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 respiratory disease, leading to recurring episodes of life-threatening infection – currently, there are no approved preventative treatments.
Research involves a 32-subject, first-in-human, double-blind, placebo-controlled, ascending dose study, delivered intravenously to groups of healthy volunteers. During the course of the trial, it will evaluate the tolerability, safety pharmacokinetic, pharmacodynamic, and immunogenicity profile of the drug.
Top-line results from the study are expected to be available in 2023 and will be used to inform further clinical trials in NCFB patients in order to reduce the severity and frequency of Pa-mediated exacerbations.
Dr Richard Fitzgerald, director of the National Institute for Health and Care Research (NIHR) Liverpool Clinical Research Facility, reflected: “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.”
“The start of the phase 1 study for our RESP-X program is a significant milestone for Infex, marking our transition from a preclinical to a clinical-stage biotechnology company,” explained Dr Peter Jackson, executive director at Infex Therapeutics. “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,” he added.
The study is being conducted at NIHR Liverpool Clinical Research Facility which is part of Liverpool University Hospital.