Amplia Therapeutics Ltd (ASX:ATX), a biotech company developing new treatments for cancer and fibrosis, has conducted successful Phase 1 clinical trials for its Focal Adhesion Kinase (FAK) inhibitor AMP945.
The double-blind, placebo-controlled trial, conducted in Melbourne and approved by the Alfred Hospital Human Research Ethics Committee (HREC), evaluated the nature, incidence and severity of adverse events and withdrawals. It also tested the efficacy of the drug in inhibiting its target.
Phase 1 success
The company has reviewed all primary, secondary and exploratory endpoints in the trial and the unblinded results confirm the drug is safe and well-tolerated at all doses tested.
These results support further development of AMP945 as a treatment for cancer and fibrosis.
“Putting all the elements of this trial together, we are now able to declare it as a resounding success," Amplia’s CEO and managing director Dr John Lambert said.
“Not only have we found that AMP945 has excellent pharmaceutical properties and appears to be suitable for once-daily oral dosing, we also know that it has a suitable safety profile for further development and, moreover, hits the intended target.”
Safe and tolerable
The 56 healthy volunteers, ranging in age from 18-65, were given single doses (125mg) and multiple doses (100mg over seven days) of the drug, orally, both before and after food.
AMP945 was well tolerated at all doses given and there were no withdrawals or serious adverse events recorded in the trial.
Mild and moderate adverse events, such as headaches, were distributed evenly across AMP945 and placebo participants and the majority of safety findings were considered to be either not related or unlikely to be related to AMP945.
There were no clinically significant changes in vital signs, clinical or laboratory parameters associated with AMP945, and no adverse safety signals or dose-related trends.
Following oral dosing, the plasma half-life of AMP945 was approximately 20 hours, indicating that AMP945 was both orally bioavailable and could be administered once daily.
Successful inhibitor
Secondary endpoints assessed AMP945’s pharmacokinetics, or how the body deals with a drug.
As part of the trial, skin biopsies were collected from participants to evaluate the ability of AMP945 to inhibit FAK in human tissues.
Samples collected from 24 of the volunteers have now been analysed. Preliminary results demonstrate that oral administration of AMP945 results in a decrease in active FAK and the extent of the inhibition of FAK activity correlates with drug levels of AMP945.
These results confirm the utility of the assay Amplia has developed to measure active FAK in human tissue samples.
The company hopes to use the test method to guide dosage its planned Phase 2 clinical trials of AMP945.
On to Phase 2
Studies are ongoing to measure the inhibitory activity of AMP945 on FAK in skin punch biopsies and to assess the plasma metabolite profiles of AMP945.
“The results of this trial reinforce our confidence that we are on a solid foundation for Phase 2 trials of AMP945 in patients with pancreatic cancer and pulmonary fibrosis,” Lambert said.