Amplia Therapeutics (ASX:ATX) has moved a step closer to a pivotal clinical program for its lead FAK inhibitor, narmafotinib, after receiving favourable feedback from the US Food and Drug Administration (FDA).
The responses followed a recent Type D meeting in which the company sought clarity on key elements of its planned Phase 2b/3 trial in pancreatic cancer.
The company said the regulator endorsed its proposed two-dose comparison for the Phase 2b stage, which will precede a larger, registration-enabling Phase 3 study evaluating narmafotinib in combination with gemcitabine and Abraxane. According to the company, the FDA’s suggestions require only minor adjustments and are not expected to affect existing timelines.
Amplia now plans to submit a complete protocol for formal FDA review in the first half of 2026, supporting its target of initiating the late-stage trial in the second half of next year.
“This is a positive outcome,” CEO and Managing Director Dr Chris Burns said. “The FDA’s feedback supports our dose-comparison strategy and allows us to move ahead with confidence. The minor changes proposed will have minimal impact on the trial timeline.”
Narmafotinib (AMP945) is a potent, selective inhibitor of focal adhesion kinase (FAK), a target of growing interest in solid tumours such as pancreatic cancer. Early-stage clinical data from Amplia’s ACCENT trial have shown encouraging response rates when the therapy is combined with gemcitabine and Abraxane, strengthening the rationale for advancing toward a registration pathway.