Clinical development company Amplia Therapeutics (ASX: ATX) has received a research and development tax incentive refund from the federal government for expenditure related to advancing its focal adhesion kinase (FAK) inhibitors for cancer and fibrotic diseases.
The company received $1.14 million to cover expenses incurred during the 2020/2021 financial year in the development of its highly-potent and selective inhibitor drugs known as AMP945 and AMP886.
Specifically, the rebate relates to a phase one clinical trial of AMP945, and associated preparatory works, which was completed during the first half of the year.
Safety and tolerability
Conducted at Nucleus Network in Melbourne using 56 healthy volunteers, the phase one trial focused on the safety and tolerability of AMP945 oral capsules by evaluating the nature, incidence and severity of adverse events, withdrawals, physical examinations, vital signs, electro-cardiograms (ECGs) and safety laboratory test results, including biochemical and haematological markers.
Volunteers received either a single dose (up to 125 milligrams) or multiple doses (up to 100mg once a day for seven days) of the drug.
It was found to be well tolerated at all doses, with no recorded withdrawals or adverse events.
Similarly, there were no significant changes in vital signs, clinical or laboratory parameters associated with AMP945 and no adverse safety signals or dose-related trends detected in any of the measured parameters.
Amplia managing director Dr John Lambert commented at the time that the trial “delivered exactly what we wanted”.
A phase two clinical trial is now being designed to test AMP945 on newly-diagnosed patients receiving first-line therapy for pancreatic cancer.
On a different research path, Amplia is progressing non-clinical studies to assess the full potential of AMP886, which also inhibits two other validated disease targets.
Research will include further assessment in a range of animal models of different cancer and fibrotic diseases to identify development, partnering and licencing opportunities.