On July 30, 2020 Amplia Therapeutics Limited (ASX: ATX) ("Amplia" or the "Company") reported that it has received preliminary final results from the preclinical toxicology studies being conducted with its FAK inhibitor, AMP945 (Press release, Amplia Therapeutics, JUL 30, 2020, View Source;[email protected] [SID1234561580]). These 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.
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The toxicology studies were conducted under a Good Laboratory Practice (GLP) quality framework and included repeat-dose administration of AMP945 in two species. Data from the repeat-dose studies allows the identification of a No Observed Adverse Effect Level (NOAEL) which can be used to determine the starting dose for the planned Phase 1 clincial trial. The Company is expecting to receive the consolidated report from these studies in late July.
Subject to approval from an independent Human Research Ethics Committee (HREC) and adequate funding, Amplia is planning to conduct the Phase 1 trial under the Australian Clinical Trials Notification (CTN) scheme. The aims of the trial will be to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AMP945 when given as single and multiple doses.
The trial is expected to take 6-9 months from first patient enrolment to collection of final data, with completion expected by mid-2021. 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), expected to commence in late 2021.
Dr John Lambert, Amplia’s CEO and Managing Director commented "we are very pleased to receive the final piece of key data from the preclinical studies conducted to date. Achieving this milestone marks an important transition for Amplia as we transform the Company into a clinical-stage drug development company."
This ASX announcement was approved and authorised for release by the Board of Amplia Therapeutics