Posted: 26 October 2023
AdAlta Limited (ASX:1AD), the clinical stage company developing novel protein and cell therapeutic products from its i-body® platform, is pleased to report that all healthy volunteers in its AD-214 Phase I extension study have now successfully received three doses, enabling pharmacokinetic and receptor engagement analysis to be completed on schedule and confirming the favourable tolerability profile observed at lower doses.
AD-214 is AdAlta’s lead drug candidate, which is being developed as a first-in-class therapy to treat debilitating and fatal fibrotic (scarring) diseases including Idiopathic Pulmonary Fibrosis (IPF). The Phase I extension study1 is designed to assess the safety and availability of multiple 10 mg/kg intravenous doses of AD-214, which is the highest dose anticipated to be used in forthcoming Phase II clinical studies.
All eight participants have now successfully received three doses of AD-214 or placebo.
Dr Tim Oldham, CEO and Managing Director, commented: “We continue to be grateful to the volunteers participating in this Phase I extension study. The favourable safety profile of AD-214 continues to be demonstrated at the anticipated Phase II clinical study doses.
“This study also supports our partnering program for AD-214 and we are pleased to have materially progressed several partnering and project financing discussions over the past month to help progress AD-214 into Phase II studies.”
Study investigators have reported no dose limiting toxicity, no need to interrupt doses and no requirement to administer medication to manage infusion reactions. The frequency of mild infusion related reactions appears lower than that observed at lower doses in the original Phase I study.2
Full pharmacokinetic and receptor engagement analysis and then updated dose finding simulations can now commence and remain on schedule for discussion with partners in November 2023. The study participants will receive a final dose in twelve weeks with the aim of confirming that there is no immune response to AD-214 that might affect efficacy and safety. Full safety and tolerability results are due in the March Quarter of 2024.
