Alderley Park, Cheshire, U.K. lnfex Therapeutics, a leading anti-infectives specialist, announces that the first patient has been dosed in a Phase lla clinical trial for RESP-X, a new anti-virulence therapy to treat Pseudomonas aeruginosa (Pa) infections in non-cystic fibrosis bronchiectasis (NCFB) patients. Pais 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 lIa trial is a 12 patient, single centre, double-blind, placebo-controlled, dose-ranging study to evaluate the safety, initial efficacy and determine the optimal dosing of RESP-X ahead of a wider Phase llb efficacy study. The study is taking place at the NIHR Clinical Research Facility in Liverpool University NHS Foundation Trust and will assess two doses of RESP-X at 6mg/kg and 10mg/kg.
RESP-X is a first-in-class anti-virulence antibody targeting chronic Pa bacterial infections in respiratory diseases. RESP-X is initially being developed as a long-term treatment to reduce disease flares/exacerbations in NCFB patients colonised with Pa, a chronic and debilitating respiratory disease. Colonisation with Pa increases the severity of NCFB, leading to recurring episodes of debilitating and life-threatening infection called exacerbations. There are currently up ta six million NCFB patients in major global markets, of which up ta 30% have chronic Pa colonisation. Despite its prevalence and severity. Despite its prevalence and severity, there are currently no licensed treatments for the prevention or reduction of infective exacerbations due to Pa colonisation in NCFB patients. There is also potential to expand the development of RESP-X into cystic fibrosis and COPD in addition to acute settings such as hospital and ventilator-acquired pneumonia and blood stream infections due to Pa.
Dr Peter Jackson, Executive Director of lnfex Therapeutics, said: “The start of the phase Ila study for RESP-X in NCFB patients is an important milestone for lnfex, which will provide valuable insights on dosing as well as early signs of efficacy in patients ahead of a larger phase Il study. RESP-X is a promising new treatment option for NCFB patients colonised with Pa, a chronic and debilitating disease that impacts millions of patients around the world for which there are currently no approved preventative treatment options. The Phase I data demonstrated an excellent safety and pharmacokinetics profile and I look forward to progressing RESP-X through phase Il.”
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