Amplia Therapeutics Limited (ASX: ATX, “Amplia”) has announced that the United States Food and Drug Administration (FDA) has awarded a second Orphan Drug Designation for Amplia’s Focal Adhesion Kinase inhibitor (FAKi) AMP945, this time for its use in the treatment of idiopathic pulmonary fibrosis (IPF).
What are the key highlights?
- The designation means that Amplia will qualify for waived FDA fees, clinical trial protocol assistance and other incentives.
- Furthermore, if Amplia secures US regulatory clearance for AMP945 for the treatment of IPF, AMP945 will qualify for seven years’ market exclusivity in FDA-administered markets.
- IPF is a devastating disease caused by the progressive build up of fibrotic tissue in patients’ lungs. It is estimated to affect over 3 million people worldwide, including over 130,000 people in the US.
- Amplia intends to start a Phase 1 clinical trial of AMP945 in healthy volunteers later this year to confirm that, like other FAKi’s, it is well tolerated.
For more information, please refer to the announcement linked below.