Preclinical Toxicology Studies Support Planned Phase 1 Clinical Trial

What's happened?

Amplia Therapeutics Limited (ASX: ATX, “Amplia”) has received preliminary final results from the preclinical toxicology studies being conducted with its FAK inhibitor, AMP945.

What are the key highlights?

1. The data, together with those produced from the preclinical toxicology program to date, have not identified any toxicities that are likely to prevent a Phase 1 trial in healthy volunteers from progressing later this year as planned.
2. The Company is expecting to receive the consolidated report from these studies in late July.
3. The aim of the Phase 1 trial will be to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AMP945 when given as single and multiple doses.
4. The trial is expected to take 6-9 months from first patient enrolment to collection of final data, with completion expected by mid-2021.
5. Data from the Phase 1 trial will support the progression of AMP945 into a Phase 2 clinical trial program in patients with various solid cancers and/or with fibrotic diseases, such as idiopathic lung fibrosis (IPF).