AdAlta (ASX:1AD), a clinical-stage company developing novel protein and cell therapeutic products from its i-body platform, has announced that all healthy volunteers in its AD-214 Phase 1 extension study have now successfully received three doses.
The company said this milestone enables the on-schedule completion of pharmacokinetic and receptor engagement analysis.
AD-214 is AdAlta’s lead drug candidate, which is in development as a first-in-class therapy to treat debilitating and fatal fibrotic (scarring) diseases, including Idiopathic Pulmonary Fibrosis (IPF).
The Phase 1 extension study is designed to assess the safety and availability of multiple 10 mg/kg intravenous doses of AD-214, the highest dose anticipated to be used in forthcoming Phase 2 clinical studies.
All eight participants have now successfully received three doses of AD-214 or placebo.
AdAlta CEO and managing director Dr Tim Oldham said, “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.”
The company said full pharmacokinetic and receptor engagement analysis and updated dose finding simulations can commence and remain on schedule for discussion with partners in November 2023.
The study participants will receive a final dose in twelve weeks to confirm no immune response to AD-214 that might affect efficacy and safety.