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Amplia (ASX:ATX) on the way to FDA assistance following second orphan drug designation
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  • Amplia Therapeutics (ATX) has announced it has been granted a second orphan drug designation for its Focal Adhesion Kinase Inhibitor, AMP945, by the United States Food and Drug Administration (FDA)
  • The designation means Amplia will qualify for waived FDA fees, clinical trial protocol assistance and other incentives
  • AMP945 will be used to treat idiopathic pulmonary fibrosis (IPF), and if it secures U.S. regulatory clearance, it will qualify for seven years' market exclusivity in FDA administered markets
  • Amplia intends to start a phase one clinical trial of AMP945 to progress into phase two clinical trials in cancer and IPF next year
  • The company's share price received a big boost following the announcement, up 86.7 per cent with shares trading for 15.5 cents each at market close

Australian pharmaceutical company, Amplia Therapeutics (ATX) has announced it has been granted a second orphan drug designation for its Focal Adhesion Kinase Inhibitor (FAKi), AMP945, by the United States Food and Drug Administration (FDA).

The designation means Amplia will qualify for waived FDA fees, clinical trial protocol assistance and other incentives.

The AMP945 drug will be used to treat idiopathic pulmonary fibrosis (IPF), and if it secures U.S. regulatory clearance, it will qualify for seven years' market exclusivity in FDA administered markets.

Amplia intends to start a phase one clinical trial of AMP945 in healthy volunteers later this year to confirm that it is well tolerated. The data from the trial will enable AMP945 to progress into phase two clinical trials in cancer and IPF patients next year.

"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."

CEO and Managing Director, Dr John Lambert

What is idiopathic pulmonary fibrosis?

IPF is a disease caused by the progressive build-up of fibrotic tissue in a patients lungs, which is estimated to affect over three million people worldwide. The disease has a profound impact on a patient’s quality of life and a median survival of only three to five years if left untreated.

The two drugs that have been approved for the treatment of IPF (pirfenidone and nintedanib) are able to slow the progression of the disease by up to 50 per cent, but are not able to treat it.

In preclinical studies using the industry-standard chemically-induced (bleomycin) lung fibrosis model, AMP945 was able to both reduce and reverse the formation of fibrotic tissue in the lungs.

The company's share price received a big boost following the announcement, up 86.7 per cent with shares trading for 15.5 cents each at market close.

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