Australian biotechnology company AdAlta (ASX:1AD) says it has received Human Research Ethics Committee (HREC) approval to commence a phase one clinical trial of its lead product candidate, AD-214.
The approval is confirmation the company has completed all the necessary preclinical safety and efficacy testing of AD-214 to commence human clinical trials.
The company said the phase one trial is being conducted under Australia’s Clinical Trials Notification (CTN) Scheme meaning no further regulatory review is required and it can now notify the TGA of HREC approval and complete site initiation activities.
It said healthy volunteer screening for 'Part A' of the trial is expected to commence in late June with the first subject expected to receive AD-214 in the second half of July. Topline safety results from the healthy volunteers are expected to be available at the beginning of 2021.
"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," said the company in a statement.
The primary endpoint of the trial is safety and tolerability of AD-214. AdAlta said it will also investigate pharmacokinetic (concentration of AD-214 in the blood over time) and pharmacodynamic (biological effects of AD-214 over time) parameters as secondary endpoints.
"The trial is not designed to show evidence of efficacy against ILD or IPF, though respiratory effects of AD-214 will be monitored for information," added the company.
According to AdAlta chief scientific officer, Professor Michael Foley, “This approval is a milestone that AdAlta has been working towards for many years. It is based on the first independent review of our complete pre-clinical development package and confirms that AdAlta has completed all the necessary safety and efficacy testing to support progressing the development of AD-214 into human clinical studies. We are incredibly grateful to the healthy volunteers, patients and physicians who will participate in this study to help improve outcomes for those suffering the debilitating effects of ILD and IPF.”
CEO and Managing Director Dr Tim Oldham added, “We are enormously proud to be able to say that AdAlta is now a clinical stage company. This milestone is significant not only for AD-214 and all the patients for whom we are working to improve outcomes, but also because it demonstrates that AdAlta can use our i-body platform to develop therapeutic candidates against complex biological receptors from discovery through the complete pre- clinical development phase.”
AdAlta also said the development of a radio-labelled version of AD-214 for PET imaging has recommenced following staged return to work at a collaborator laboratory. The radio-labelled version remains on track for introduction into the patient cohorts of the phases one program in the first quarter of 2021.