Amplia Therapeutics Ltd - FDA Awards Amplia Orphan Drug Designation for Idiopathic Pulmonary Fibrosis
Amplia Therapeutics Ltd (ASX:ATX)

FDA Awards Amplia Orphan Drug Designation for Idiopathic Pulmonary Fibrosis


What's happened?

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?

  1. The designation means that Amplia will qualify for waived FDA fees, clinical trial protocol assistance and other incentives.
  2. 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.
  3. 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.
  4. 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.

CEO's Summary

John Lambert

"This Orphan Drug Designation further highlights the extensive opportunities provided by Amplia’s pipeline. With the preclinical toxicology program for AMP945 nearing completion, the company is rapidly moving toward commencement of a Phase 1 study in healthy volunteers later this year. Our development plan for AMP945 has been specifically structured to leverage the Company’s opportunities in both cancer and fibrosis. This Orphan Drug Designation for the use of AMP945 to treat patients with IPF provides further validation of the pipeline of opportunities we are putting in place for our proprietary FAK inhibitors.

John Lambert
CEO, Amplia Therapeutics Ltd

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