Infex Therapeutics Holdings PLC, an anti-infectives specialist, 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).
The final group in the first stage trial will be administered doses of RESP-X at a concentration of 10mg/kg. Preliminary data from earlier cohorts have been promising, indicating that RESP-X was well tolerated with no reported severe adverse events.
The phase IIa evaluation will delve deeper, aiming to pinpoint the optimal dosing of RESP-X before progressing to a broader efficacy assessment. The initial group in this cohort will be given doses of RESP-X at 6mg/kg.
Sourced from Japanese pharmaceutical giant Shionogi, the drug is the first-of-its-kind immune infection antibody.
It's specifically tailored to target chronic Pa bacterial infections in NCFB patients.
The presence of Pa can exacerbate NCFB, resulting in recurrent episodes of severe, life-threatening infections.
Despite the global prevalence of NCFB, affecting around eight million individuals, and the severity of Pa infections, which impact 30% of these patients, there remains a void in approved treatments for Pa colonisation in NCFB patients.
"It is pleasing to see that RESP-X continues to exhibit a strong safety and tolerability profile, with approval now received to dose the final cohort of the phase Ia study," said chief executive Peter Jackson.
"Importantly, we now have approval to begin dosing the first cohort of the first-in-patient phase IIa dose-ranging study, to identify the optimal dosing of RESP-X ahead of a wider phase II efficacy study. We believe RESP-X is a potential blockbuster opportunity targeting an urgent unmet medical need, for which there are currently no approved treatments."