Amplia Therapeutics Ltd - Amplia Receives Human Research Ethics Committee Clearance to Conduct Phase 1 Clinical Trial
Amplia Therapeutics Ltd (ASX:ATX)

Amplia Receives Human Research Ethics Committee Clearance to Conduct Phase 1 Clinical Trial


What's happened?

Amplia Therapeutics Limited (ASX: ATX, "Amplia") has received clearance from the Alfred Hospital Human Research Ethics Committee (HREC) to conduct a Phase 1 clinical trial of its Focal Adhesion Kinase (FAK) inhibitor, AMP945, in healthy volunteers.

What are the key highlights?

  1. With this clearance in hand, Amplia expects to initiate its Phase 1 trial in the coming weeks with the first subject likely to be dosed by early October.
  2. The double blind, placebo-controlled Phase 1 trial is designed to establish the safety profile of oral doses of AMP945 in up to 64 healthy adult volunteers.
  3. Amplia is on track to complete dosing of subjects for the single ascending dose (SAD) component of the Phase 1 trial by the end of the year and have data from the completed trial in the first half of 2021.
  4. Data from this trial will be used to support Phase 2 clinical trials of AMP945 for the treatment of patients with specific, hard-to-treat cancers or with certain fibrotic diseases.

For further information, please refer to the announcement linked below.

CEO's Summary

John Lambert

We are very excited to receive ethics approval for Amplia’s first clinical trial and to deliver on our commitment to advance AMP945 into human clinical trials during 2020. Despite the challenges thrown up by the current COVID-19 pandemic, in the past few months we have managed to secure two Orphan Drug Designations, complete the preclinical studies required to support the Phase 1 trial, secure funding to conduct the trial, and now receive the approval required to initiate the trial. We are extremely grateful for the support we have received from our partners, providers and shareholders that has allowed us get to this stage and initiate the first-in-human study for AMP945.”

John Lambert
CEO, Amplia Therapeutics Ltd

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