Posted: 7 August 2023
AdAlta Limited (ASX:1AD), the clinical stage drug discovery company developing novel therapeutic products using its i-body platform provides an update on its lead fibrosis asset, AD-214. The first participants in the Company’s Phase I extension study of AD-214 have successfully received their first dose.
The Phase I extension study, titled “Safety, Tolerability, PK and PD Study of AD-214 Administered to Healthy Volunteers and Patients with Interstitial Lung Disease or Chronic Kidney Disease”,1 aims to confirm safety and pharmacokinetic and pharmacodynamic profile of multiple doses of AD-214, using higher doses than in the previous Phase I study. Commencing this study returns AD-214 to the clinic more than a year earlier than forecast in 2022. The new clinical data is crucial as it will better inform the safety profile and target dosing schedule of AD-214 for future Phase II studies and will also strengthen partnering initiatives.
AdAlta CEO and Managing Director, Dr Tim Oldham commented, “We extend our gratitude to the volunteers who are participating in this extension study. Their involvement is essential in advancing a potential new therapy for sufferers of debilitating and incurable idiopathic pulmonary fibrosis and other fibrotic diseases. The Company’s meetings with potential partners continue to indicate that this study will materially enhance the attractiveness of AD–214 to partners.”
The study is initially enrolling up to 8 healthy volunteers, six participants to receive AD-214 and two participants placebo. The first, or sentinel, group of two participants has now received the first of four 10 mg/kg doses of AD-214 or placebo with no issues reported. AdAlta continues to anticipate interim results before the end of 2023, with final assessment visits to be completed and full results expected to be available in the first quarter of 2024.
