Melbourne, Australia: Amplia Therapeutics Ltd (ASX: ATX), (“Amplia” or the “Company”, a company
developing new approaches for the treatment for cancer and fibrosis, is pleased to announce that it
has successfully completed the dosing of subjects in the Single Ascending Dose (SAD) component of
the Phase 1 clinical trial of its proprietary focal adhesion kinase (FAK) inhibitor AMP945.
The Single Ascending Dose study involved four cohorts of healthy volunteers. The last cohort of
volunteers received the highest single dose of AMP945 administered to date and achieved drug
exposures corresponding to the maximum allowable level specified in the trial design. As noted for
prior cohorts, the highest single dose AMP945 was found to be well tolerated and no safety concerns
were identified.
Last month, Amplia announced that it had started dosing subjects for the Multiple Ascending Dose
(MAD) component of its Phase 1 trial. The Company remains on track to complete dosing and report
top-line data from this trial in the June quarter. Dr John Lambert, CEO of Amplia commented: “We are
very encouraged by the data that is coming in from this Phase 1 clinical study. Our focus is now on
completing the trial in a timely manner, fully analysing the data and preparing for future clinical studies
in patients with cancer and fibrosis.”
This ASX announcement was approved and authorised for release by the Board of Amplia
Therapeutics.
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