Amplia Therapeutics Limited (ASX: ATX, “Amplia”) today announced that the United States Food and Drug Administration (FDA) has awarded Amplia’s Focal Adhesion Kinase inhibitor (FAKi) AMP945 Orphan-Drug Designation for the treatment of pancreatic cancer.
What are the key highlights?
- The designation means that Amplia will qualify for waived FDA fees, clinical trial protocol assistance and other incentives.
- If the FDA ultimately approves AMP945 for the treatment of pancreatic cancer, Amplia would qualify for seven years’ market exclusivity in FDA-administered markets.
- Amplia is aiming to start a Phase 1 clinical trial of AMP945 in healthy volunteers later this year to confirm that, like other FAKi, it is well tolerated.