On November 17, 2021 Amplia Therapeutics Limited (ASX: ATX), ("Amplia" or the "Company"), a company developing new drugs for the treatment of cancer and fibrosis, reported that it has received new data from its recent Phase 1 clinical trial that demonstrates the ability of AMP945 to inhibit the intended target, Focal Adhesion Kinase (FAK), in human volunteers when given as an orally administered capsule (Press release, Amplia Therapeutics, NOV 17, 2021, View Source;[email protected] [SID1234595754]). This supplementary data further strengthens the Company’s confidence in the planned Phase 2 clinical program as it shows that safe and well-tolerated oral doses of AMP945 can achieve sufficient drug levels in humans to inhibit FAK.

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The primary focus of Amplia’s recent Phase 1 clinical trial was to establish the safety, tolerability and pharmacokinetics of AMP945. As part of the trial, skin biopsies were collected from participating healthy volunteers to evaluate the ability of AMP945 to inhibit FAK in human tissues. Analysis of these samples required Amplia to develop a sensitive assay that allowed the measurement of the active form of FAK (phospho-FAK or pFAK) in skin samples before and after AMP945 was administered. The data from these studies have now been analysed and demonstrate that oral administration of AMP945 results in a decrease in active pFAK and the extent of the inhibition of FAK activity correlates with drug levels of AMP945.

In addition to demonstrating the dose-dependent reduction in pFAK in healthy volunteers, these results verify the utility of the assay used to measure pFAK in human tissue samples, confirming the availability of a test method which can be used to guide dose selection in the Company’s planned Phase 2 clinical trials of AMP945.

"We are very encouraged by the way all the data is lining up as we prepare to start our first Phase 2 clinical trial of AMP945," said Dr Mark Devlin, Chief Scientific Officer at Amplia. "Being able to observe inhibition of FAK in human volunteersis an important piece of the jigsaw. We have observed inhibition of FAK by AMP945 in animal models and this has been associated with anti-tumour and anti-fibrotic activity. Getting such clear and compelling FAK inhibition data in our Phase 1 trial is very pleasing and provides additional comfort as we start trialling AMP945 in patients. Furthermore, we now have an assay for monitoring the effects of AMP945 that can be used to guide dosing in our upcoming Phase 2 trials in pancreatic cancers and other fibrotic diseases."

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