Pharmaceutical company Amplia Therapeutics (ASX: ATX) has announced the unblinded results of a phase one clinical trial that supports further development of its drug AMP945 in cancer and fibrosis.
The results confirmed the company’s preliminary analyses and showed the drug was safe and well tolerated at all doses tested in the trial.
Amplia chief executive and managing director Dr John Lambert said the trial delivered exactly what the company was hoping for.
“AMP945 has been shown to have a safety and tolerability profile suitable for progressing it into phase two trials in both pancreatic cancer and pulmonary fibrosis,” he said.
Dr Lambert said the phase two trial in pancreatic cancer is expected to start “around the end of 2021”.
Phase one results
Amplia’s clinical trial was a phase one randomised, double blind, placebo-controlled study of the safety and pharmacokinetics of single and repeat doses of AMP945.
The study was conducted under a protocol agreement approved by the Alfred Hospital Human Research Ethics Committee (HREC) in September 2020.
Its primary endpoints were focused on the safety and tolerability of orally administered AMP945. Secondary endpoints assessed the pharmacokinetics of the drug.
A total of 56 healthy adult volunteers ranging between the ages of 18-65 were dosed (via capsules taken with a glass of water) with either single (125mg) or multiple (100mg) doses of AMP945 or placebo. The multiple doses were taken once daily for seven days. To study the effect of food on absorption of the drug, one cohort of participants was given AMP945 both before and after food.
According to the company, study results showed AMP945 was well tolerated at all doses given and there were no withdrawals or serious adverse events recorded in the trial. Adverse events were “generally mild or moderate” and were distributed evenly across participants.
The most frequently observed adverse event was a mild headache and events that were considered “possibly” related to AMP945 included one incidence of diarrhoea, two incidences of headache, one taste disorder and one hot flush.
Following oral dosing, the plasma half-life of AMP945 was about 20 hours indicating the drug was both orally bioavailable and could be administered once daily.
Plasma levels of AMP945 exceeded the concentrations required to inhibit the intended target, focal adhesion kinase (FAK) with maximum plasma levels being achieved after about two to four hours post-dose.
There was no reported evidence of any food effect on the absorption of the drug. Studies are ongoing to measure the inhibitory activity of AMP945 on FAK in skin punch biopsies and to assess the plasma metabolite profiles of the drug.