RESP-X, Infex Therapeutics’ anti-virulence therapy to treat Pseudomonas aeruginosa (Pa) infections in non-cystic fibrosis bronchiectasis (NCFB) patients, has shown a promising interim safety and tolerability profile in its ongoing first-in-human Phase I clinical trial.
The first cohort consisted of eight healthy volunteers who received doses of RESP-X at 1mg/kg. No serious adverse events were reported, and there were no treatment-related trends in vital signs, ECG, clinical laboratory evaluations, or physical evaluations.
Dosing of the second cohort of healthy volunteers will now proceed at 3mg/kg. The study is being conducted at the Clinical Research Facility of the Liverpool University Hospital NHS Foundation Trust.
The results have accelerated plans for a first-in-patient study (Phase IIa dose-ranging study), which will consist of two cohorts of NCFB patients to determine the optimal dose ahead of a wider Phase II efficacy study.
Dr Peter Jackson, CEO of Infex Therapeutics, said: “The success of the first cohort of this Phase I clinical trial for RESP-X is encouraging, and we are eager to move forward with the next steps of the study. With further research and development, RESP-X could become a critical new preventative treatment option for NCFB patients with Pseudomonas aeruginosa colonisation.”
NCFB is a chronic lung condition that affects the airways in the lungs, causing them to widen and become damaged. It can lead to recurrent infections, difficulty breathing, and reduced quality of life. Colonisation with the bacteria Pa increases the severity of the illness, leading to recurring episodes of life-threatening infection and there are currently no approved preventative treatments.
