16 July 2019
AdAlta Limited (ASX: 1AD), the biotechnology company advancing its lead i-body candidate toward clinical development, has commenced its key toxicology study with AD-214, representing the final step before initiation of the human clinical trial for AD-214, which is being developed to treat Idiopathic Pulmonary Fibrosis.
AdAlta has initiated its four-week non-human primate study to evaluate the safety and toxicology of AD-214, which is being completed under Good Laboratory Practice (GLP) conditions. Data from this toxicology study is expected in the second half of 2019 and will inform the dosing regimen and safety readouts for AdAlta’s human clinical trial. The results will also form part of a subsequent IND (investigational new drug) submission to the US FDA and will be of interest to potential partners evaluating AD-214.
The four-week non-human primate study is being undertaken with AD-214 materials from a recently completed demonstration run, highlighting the achievement of another manufacturing milestone. AdAlta now remains focused on delivering material manufactured under Good Manufacturing Practice (GMP) conditions which is necessary for its Phase 1 human study, expected to commence in January 2020.
“We are excited to start this critical non-human primate study which will enable us to commence our human clinical studies. As per our timeline proposed 12 months ago and without delay, we
have met all our manufacturing objectives for our lead candidate, AD-214. Manufacturing is a key step in making any product, and is particularly difficult with new biologic drugs. We are delighted
to have met this critical milestone as anticipated,” said AdAlta’s Chief Executive Officer, Sam Cobb.
“We now have the materials to commence our four-week toxicology study, which will evaluate the safety of AD-214. It is the final step before we start our human trials this coming January.”
The completion of manufacturing follows the announcement in May that a confirmation run had been completed, demonstrating that AD-214 can be made at sufficient yields to meet our preclinical and clinical programs.
For more information, please contact:
Sam Cobb, CEO
Tel: +61 (0)3 9479 5159