Australian pharmaceutical company Amplia Therapeutics (ASX:ATX) reports it has started dosing patients as part of its ongoing phase 1b/2a ACCENT clinical trial of focal adhesion kinase (FAK) inhibitor AMP954.
The company says the first patient recruited to the second cohort of the ACCENT trial has received their first increased dose of AMP945 following the safety committee’s recent assessment that the AMP945 dose used in cohort 1 was ‘safe’ and ‘well-tolerated’.
Adding on, Amplia Therapeutics notes cohort 2 will consist of 3 patients receiving the increased dose of AMP945.
Speaking on the recruitment, Amplia Chief Executive Officer (CEO) and Managing Director Dr. Chris Burns said: “Identifying a safe and well-tolerated dose of AMP945 that effectively shuts down FAK activity is a critical part of the phase 1b arm of the ACCENT trial.
“Based on our extensive preclinical studies, we are hopeful that AMP945 used in conjunction with standard-of-care drugs gemcitabine/nab-paclitaxel, will improve patient outcomes”
Based on our extensive preclinical studies, we are hopeful that AMP945 used in conjunction with standard-of-care drugs gemcitabine/nab-paclitaxel, will improve patient outcomes. As always, we are grateful to the patients and their loved ones for consenting to take part in this trial.”
The company also notes the ACCENT trial is entitled “A phase 1b/2a, Multicentre, Open Label Study of the Pharmacokinetics, Safety and Efficacy of AMP945 in Combination with Nab-paclitaxel and Gemcitabine in Pancreatic Cancer Patients”, and that the trial is set to be conducted in 2 stages.
The first phase 1b stage of the trial represents a single-arm open-label study to select an optimal dose of AMP945 by assessing the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of AMP945 when applied in combination with gemcitabine and nab-paclitaxel in first-line patients with advanced pancreatic cancer.
Meanwhile, the second phase 2a stage of the trial is also a single-arm open-label study that is designed to perform an assessment of the optimal dose of AMP945 in combination with gemcitabine and nab-paclitaxel, however the primary endpoint of the phase 2a trial is the Objective Response Rate (ORR) of patients to treatment.
Further endpoints are reported to assess efficacy by other means as well as safety and tolerability.
Amplia Therapeutics is an Australian pharmaceutical company working to advance a pipeline of FAK inhibitors for cancer and fibrosis. The company trades on the ASX and as of 5pm AEST is trading at a share price of $0.09.