Posted: 30 June 2023
AdAlta Limited (ASX:1AD), the clinical stage drug discovery company developing novel therapeutic products from its i-body platform, is pleased to announce that it has received Human Research Ethics Committee (HREC) approval to commence a Phase I extension clinical study of its lead product candidate, AD-214. This approval covers both a healthy volunteer cohort (Part A), and a subsequent patient cohort (Part B).
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”, is being conducted under Australia’s Clinical Trials Notification (CTN) Scheme, meaning that no further regulatory review is required.
The study will recruit up to 8 healthy volunteers in the previously announced1 Part A who will receive four 10 mg/kg doses of AD-214. The approval also allows a further 8 fibrotic disease patients suffering interstitial lung disease (including IPF) or chronic kidney disease to be recruited in Part B. Part A will be conducted at C-MAX in Adelaide, with first participant dosing anticipated in August 2023.
AdAlta Director Clinical and Regulatory Operations, Darryn Bampton, commented, “The AD-214 Phase I extension study aims to confirm safety and pharmacokinetic and pharmacodynamic trends of multiple doses of AD-214 using higher doses than in the previous study. This data is important to establish the safety and to better inform the target dosing schedule of AD-214 at the doses planned for Phase II studies.” AdAlta CEO and Managing Director, Dr Tim Oldham added, “Our meetings with potential partners at BIO23 in Boston in June confirmed that this extension study will materially enhance our ongoing partnering discussions as well as shortening eventual Phase II study time and cost. We thank all those shareholders who participated in the recent Rights Offer,2 that contributed towards the funds for Part A of this critical Phase I extension.
We also thank in advance those volunteers who will participate in this extension study, to help progress a potential new therapy for sufferers of idiopathic pulmonary fibrosis and other fibrotic diseases.” Details of the study can be found at: www.clinicaltrials.gov/study/NCT05914909
