Amplia Therapeutics prepares for phase two AMP945 trial backed by shareholders

Amplia Therapeutics ASX ATX cancer fibrosis AMP945 small molecule focal adhesion kinase FAK inhibitor program
The design of Amplia’s phase two trial of AMP945 in pancreatic cancer patients is due to be finalised during the quarter.

Amplia Therapeutics (ASX: ATX) will be spending the September quarter finalising the design of phase two clinical trials of its lead drug AMP945 in both pancreatic cancer and idiopathic lung fibrosis (IPF) patients.

This work is being supported by a $3.8 million capital raising completed in May and follows the success of a phase one trial that showed the drug was safe and well tolerated at all tested dosages.

The Australian pharmaceutical company, which aims to develop new treatments for cancer and fibrosis, today posted its activities and cash flow reports for the three months ended June 2021.

Amplia chief executive officer and managing director Dr John Lambert said the company’s progress during the last quarter has placed it in a strong position for its next stage of clinical development.

“The results from our successful phase one clinical trial announced last week have confirmed that AMP945 has a profile which makes it very suitable for advancing into phase two clinical trials in both patients with pancreatic cancer and IPF.”

He added that the new capital raised during the last quarter will help the company prepare for the launch of its phase two clinical program later this year.

“Amplia is very appreciative of the support it received from new and existing shareholders,” he said.

The company also finalised a collaboration agreement with the Garvan Institute of Medical Research in Sydney before the end of the quarter.

Dr Lambert said the partnership has already provided valuable data validating Amplia’s strategy to “add AMP945 into existing standard-of-care therapies to enhance the currently poor response experienced by patients with pancreatic cancer”.

Phase two clinical trial plans

Amplia said plans for the phase two trial of AMP945 in patients with pancreatic cancer are “well advanced” and its design is expected to be finalised during the current quarter.

The company has engaged a range of clinicians, regulatory and biostatistics consultants and other experts to assist with this process and is incorporating their advice into the design of the trial.

Amplia has also begun the scale-up manufacture of AMP945 and longer-term animal toxicology studies required to support the phase two trial in IPF, which is scheduled to start in mid-2022.

In parallel, the company plans to continue non-clinical studies for both AMP945 and another drug candidate AMP886 to expand data sets supporting the potential use of the drugs in other therapeutic areas.

R&D expenditure set to decrease

Amplia spent $1.34 million in operating expenditure during the last quarter with $933,000 of this used for research and development primarily focused on closing out the phase one clinical trial of AMP945.

With recruitment having been completed in the phase one trial, it forecast a decrease in research and development costs for the September quarter.

The company ended the June quarter with $4.08 million in cash.

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