AdAlta recently achieved a transformational milestone, with ethics approval of our phase I human trial for lead candidate AD-214 marking our successful transition to a clinical stage biotechnology company.
The approval is the first independent review of our complete pre-clinical development package and confirms that we have completed all the necessary safety and efficacy testing to support progressing the development of AD-214 into human clinical studies, a milestone that the AdAlta team has been working towards for many years.
Our CEO Dr Tim Oldham says that ethics approval is a “coming of age moment”, and notes the milestone is important for three reasons.
“It validates the quality of the work we have done to date on AD-214, it proves that we can develop a drug all the way from discovery through to clinical stage, and this study will help validate our entire platform,” he says.
“I’m incredibly proud of this achievement and incredibly grateful to everyone who has been involved on our journey so far and to those who will be involved in our study as we work towards improving outcomes for those patients suffering the debilitating effects of ILD and IPF.”
For more information on the significance of ethics approval, watch the video interview with Dr Oldham here.
Our announcement on ethics approval was also featured in online financial news outlet, The Sentiment. You can read the article here.
About the phase I study of AD-214
The first subject in the phase I study is expected to receive AD-214 in the second half of July and top-line safety results from the healthy volunteers are expected to be available at the beginning of CY2021.
Subject to satisfactory completion of Part A of the trial, initiation of Parts B and C of the trial in patients with Interstitial Lung Disease (ILD), including patients with Idiopathic Pulmonary Fibrosis (IPF), is expected early in 2021. The primary end point of the trial is safety and tolerability of AD-214. The trial is not designed to show evidence of efficacy against ILD or IPF.