Data demonstrates a sound safety and tolerability profile for therapy during phase 1 clinical trial
Infex – a company focusing on anti-infectives – has announced that its candidate, RESP-X, has shown a promising interim tolerability and safety profile.
RESP-X is an anti-virulence therapy, which has been developed to treat Pseudomonas aeruginosa (Pa) infections in non-cystic fibrosis bronchiectasis (NCFB) patients. The data has emerged from a phase 1 study involving a group of healthy volunteers.
This initial cohort was made up of eight healthy volunteers who received doses of RESP-X at 1mg/kg. Consequently, no serious adverse reactions were reported, and there were no treatment-related trends in vital signs, clinical laboratory evaluations, physical evaluations or electrocardiography. Meanwhile, no local tolerability concerns were recorded at the infusion location.
The results have boosted plans for a phase 2 study – which will involve two cohorts of NCFB patients – to establish the optimal dose in anticipation of broader efficacy research.
Dr Peter Jackson, chief executive officer at Infex Therapeutics, was optimistic about the results: “The success of the first cohort of this phase 1 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.”
Dosing of the next cohort of healthy volunteers will now commence at 3mg/kg. The research is unfolding at the Clinical Research Facility of the Liverpool University Hospital NHS Foundation Trust.
NCFB remains a serious lung condition with a high unmet medical need. It impacts the lung airways, causing them to widen and become damaged. Furthermore, it can lead to recurrent infections, difficulty breathing and a reduced quality of life.
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