- Amplia Therapeutics (ATX) has begun a Multiple Ascending Dose (MAD) study in the phase one clinical trial of its AMP945 drug for the treatment of cancer and fibrosis
- The phase one trial in healthy volunteers is designed to look into the safety and tolerability profile of AMP945 through a Single Ascending Dose (SAD) study
- The study is nearing completion and has not yet identified any safety or tolerability concerns
- Following on from the SAD study, Amplia began the MAD study, with the first subjects set to be dosed this week
- The company will use data from both studies to help establish the appropriate doses of AMP945 to be evaluated in phase two clinical trials
- Amplia Therapeutics is up 7.41 per cent, trading at 29 cents
Amplia Therapeutics (ATX) has commenced a Multiple Ascending Dose (MAD) study in the phase one clinical trial of its proprietary focal adhesion kinase inhibitor, AMP945, for the treatment of cancer and fibrosis.
The phase one trial in healthy volunteers is designed to study the safety and tolerability profile of AMP945, as well as a number of pharmaceutical parameters in human subjects.
During the first Single Ascending Dose (SAD) study of the treatment, subjects were closely monitored after being given a single dose of the drug. The study is nearing completion and, as yet, has not identified any safety or tolerability concerns associated with the AMP945.
Following on from the SAD study, Amplia began the MAD study, with the first subjects set to be dosed this week. In this stage of the phase one trial, three cohorts of subjects will be exposed to different doses of AMP945 over seven days.
The company will use data from both studies to help establish the appropriate doses of AMP945 to be evaluated in phase two clinical trials, expected to begin at the end of the year.
In addition to studying the safety and tolerability of AMP945, the phase one clinical trial also looked into the impact of food on the absorption of the treatment, the pharmacokinetics of the drug, and the ability of the drug to inhibit the FAK enzyme in the human body.
“We are delighted that we have been able to advance AMP945 into our MAD study on the basis of the positive data seen so far in the SAD study,” said CEO of Amplia, John Lambert.
“AMP945 is a very specific inhibitor of the FAK enzyme and has very little off-target activity. The excellent safety profile that we have seen in our SAD study to date is consistent with data from our preceding non-clinical studies”.
The CEO said he was encouraged by the data seen in the trial. The company expects to report on results from phase one in Q2 2021.
Amplia Therapeutics is up 7.41 per cent, trading at 29 cents at 1:10 pm AEDT.