Amplia Completes Dosing in Phase 1 Clinical Study of AMP945

Melbourne, Australia: Amplia Therapeutics Limited (ASX: ATX), (“Amplia” or the “Company”), a company developing new drugs for the treatment for cancer and fibrosis, is pleased to announce that it has successfully completed the dosing of subjects in the Company’s Phase 1 clinical trial of its proprietary focal adhesion kinase (FAK) inhibitor AMP945.

The Phase 1 trial was primarily designed to study the safety and tolerability profile of AMP945, as well as a number of pharmaceutical parameters and included multiple cohorts of healthy volunteers who received either single or multiple doses of AMP945. All doses have now been administered and there have been no tolerability concerns or dose-limiting adverse events. During the second quarter of 2021, analysis of the trial results will be conducted and documented in a detailed clinical trial study report
(CSR).

The promising safety profile observed to date supports the Company’s plan to incorporate AMP945 into new and existing treatment regimens for pancreatic cancer patients as well as to address certain fibrotic diseases such as pulmonary fibrosis.

“It is exciting to have completed the dosing period of this trial and to see such a robust safety and tolerability profile for AMP945. We now plan to commence Phase 2 clinical trials in patients within the next 12 months.” said Dr John Lambert, CEO of Amplia. “I would also like to take this opportunity to thank everyone who has been involved in this trial and, in particular, to the volunteers who agreed to participate.”

This ASX announcement was approved and authorised for release by the Board of Amplia Therapeutics.