AdAlta Ltd (ASX:1AD) has received Human Research Ethics Committee (HREC) approval to extend the Phase 1 clinical study of its lead product candidate AD-214 targeting fibrotic disease including idiopathic pulmonary fibrosis.
“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,” AdAlta director of clinical and regulatory operations Darryn Bampton explained.
“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.”
Extension study
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.
Extending the study will allow for eight more fibrotic disease patients suffering interstitial lung disease or chronic kidney disease to be recruited in Part B of the trial, which would contribute to confirming the safety of AD-214 when administered in combination with standard of care.
The study will recruit up to eight healthy volunteers in the previously announced Part A who will receive four 10 mg/kg doses of AD-214.
This approval also allows a further eight fibrotic disease patients suffering interstitial lung disease (including IPF) or chronic kidney disease to be recruited in Part B.
Enhancing partner discussions
“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 shorten eventual Phase II study time and cost,” AdAlta CEO and managing director Dr Tim Oldham said.
“We thank all those shareholders who participated in the recent rights offer 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.”
Phase A of the trial is set to begin in August this year – supported by $3.15 million in funding from a recent rights offer – at C-MAX in Adelaide.
AdAlta expects the first results – from top-line healthy volunteers – to be available in January next year.