6 April 2023
INFEX Therapeutics interim results demonstrate a favourable safety and tolerability profile for RESP-X in ongoing Phase I clinical trial
Alderley Park, Cheshire U.K. Infex Therapeutics, a leading anti-infectives specialist, is pleased to announce that RESP-X, the Company’s new 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 data from the first cohort of healthy volunteers in its ongoing first-in-human Phase I clinical trial (the ”Study”).
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. Additionally, no local tolerability concerns were reported at the infusion site.
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 promising 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.
NCFB is a chronic lung condition with a high unmet medical need. It 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. RESP-X shows promise as a potential treatment for NCFB patients with Pseudomonas aeruginosa colonisation.
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.”