Amplia Therapeutics Limited (ASX: ATX) has appointed Nucleus Network in Melbourne to conduct its upcoming Phase 1 clinical trial testing AMP945, the company’s proprietary Focal Adhesion Kinase inhibitor (FAKi).
The Australian pharmaceutical company is advancing a pipeline of Focal Adhesion Kinase (FAK) inhibitors for cancer and fibrosis. FAK is an increasingly important target in the field of cancer immunology and Amplia has a particular development focus in pancreatic and ovarian cancer. FAK also plays a significant role in a number of chronic diseases, such as idiopathic pulmonary fibrosis (IPF).
CEO and Managing Director, Dr John Lambert, said Amplia has completed all required preclinical studies for its first-in-man study of AMP945 and has recently announced a fully underwritten Entitlement Offer to secure the funds required to complete the trial. As a result, the trial remains on track to start in the second half of 2020.
The Phase-1 trial will enrol up to 64 healthy volunteers and aims to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AMP945 when given as single and multiple doses.
Dr Lambert said that by conducting the trial in healthy volunteers, data from the trial may be used to support Phase 2 clinical trials for multiple diseases including various solid cancers and fibrotic diseases such as idiopathic pulmonary fibrosis. The company expects data from the Phase 1 trial to be available in the first half of 2021.
This Phase 1 trial has been designed to unlock the multiple opportunities that AMP945 provides,” Dr Lambert said.
“We are delighted that Nucleus Network is able to support us in this significant step for the company.
“During the selection process, the responsiveness of the Nucleus team and the professionalism of their organisation impressed us, and we look forward to working together to conduct the trial.”
The trial is planned to proceed under the Australian Clinical Trials Notification (CTN) framework and initiation of the trial will be subject to the approval of an independent Human Research Ethics Committee (HREC) which is expected to be applied for in the coming weeks.
