AdAlta’s AD-214 demonstrates safety and efficacy potential for fibrotic disease treatment
Top-line results from a Phase I extension study of AdAlta’s (ASX: 1AD) lead asset AD-214 in the treatment of fibrotic disease have established the safety, tolerability and bioavailability of a target dose for planned Phase II clinical studies.
The results are reported to have also positively answered key questions from pharmaceutical partner companies in support of a progression to Phase II studies focusing on idiopathic pulmonary fibrosis (IPF).
The Phase I extension study showed AD-214 was well-tolerated by healthy volunteers, who received multiple intravenous doses at 10 milligrams per kilogram of body weight every two weeks.
It showed no evidence of elevated antidrug antibodies (ADAs) or other adverse effects which may detract from its efficacy after extended use in diseases such as IPF.
ADAs are a common response to biologic drugs that, when present in significant concentrations, can reduce the effectiveness of a drug over time.
PK and PD results
AD-214’s availability (pharmacokinetics or PK) and engagement with target receptors (pharmacodynamics or PD) were shown to be consistent across all doses and in line with prior single-dose studies.
PK measures the concentration of a drug in the blood over time.
A minimum concentration is required for therapeutic effect and should be consistently maintained over multiple doses.
PD measures the immediate effect of a drug on its target biological system and – while not the same as efficacy against disease – is considered an important indicator of the drug retaining its function in the body.
The similarity of all PK and PD results after the first and fourth dose of AD-214 confirmed that participants did not develop tolerance to the drug and that the presence of any ADAs had not impacted the availability or activity of AD-214.
This supports AdAlta’s hypothesis that low levels of ADAs are unlikely to be of concern in a clinical safety or efficacy context.
All other clinical safety results, including liver function and blood chemistry, were reported to be within normal ranges.
Phase II studies
AdAlta managing director Tim Oldham said the completion of the Phase I extension study supports progressing the dose regimen into Phase II clinical studies.
“With these excellent results, we believe we have answered in the best way possible the key clinical questions that our large pharma company partners have been asking about AD-214,” he said.
“The molecule is now prepared for Phase II clinical studies, a significant milestone for AdAlta.”
“We have already commenced the process of sharing these latest results with our potential partners with a view to progressing a licensing or asset financing transaction in the near term.”
“Such a transaction would enable AD-214 to advance to Phase II clinical trials in IPF to provide a new option for patients with this debilitating and fatal disease as well as providing a return on our investment to date.”