RESP-X / Infex Therap, Shionogi - LARVOL DELTA

Novel humanized anti-PcrV monoclonal antibody COT-143 protects mice from lethal Pseudomonas aeruginosa infection via inhibition of toxin translocation by the type III secretion system. (PubMed, Antimicrob Agents Chemother) - "These results suggest that COT-143 facilitates P. aeruginosa clearance by protecting neutrophil via inhibition of T3SS-dependent toxin translocation. This is the first report to show that an anti-PcrV antibody directly interferes with translocon formation to inhibit intoxication of host cells."

Journal • Preclinical • Infectious Disease

Infex gets the green light for the next stage in its clinical trial programme (Proactiveinvestors) - "Infex Therapeutics...has secured approval to initiate dosing for the concluding group of phase Ia study of healthy volunteers and to kick off the first patient dosing in the phase IIa evaluation of its key asset, RESP-X....The drug therapy is designed to combat Pseudomonas aeruginosa (Pa) infections in people with non-cystic fibrosis bronchiectasis (NCFB)."

Trial status • Bronchiectasis • Infectious Disease • Non‐Cystic Fibrosis Bronchiectasis

Positive study results for Infex’s RESP-X (PharmaTimes) - P=1 | N=8 | "Data demonstrates a sound safety and tolerability profile for therapy during phase 1 clinical trial....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 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.'"

P1 data • Bronchiectasis • Non‐Cystic Fibrosis Bronchiectasis • Respiratory Diseases

Infex begins study of pseudomonas aeruginosa candidate RESP-X (PharmaTimes) - "Infex...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....Top line results from the study are expected to be available in 2023...'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.'"

New P1 trial • P1 data • Bronchiectasis • Non‐Cystic Fibrosis Bronchiectasis

MHRA approves Infex Therapeutics’s study for treatment for non-cystic fibrosis patients (PMLive) - "Infex Therapeutics...has been given approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) to initiate a phase 1 study of its RESP-X programme....Infex expects the phase 1a/b clinical study to start in the second half of 2022 as a single centre, first-in-human, double-blind, placebo-controlled, intravenous single ascending dose study....The trial will asses the safety, tolerability, pharmacokinetic, pharmacodynamic and immunogenicity of RESP-X in healthy patients and NCFB patients."

New P1 trial • Bronchiectasis • Infectious Disease • Non‐Cystic Fibrosis Bronchiectasis