The Amplia Therapeutics Ltd (ASX: ATX) share price is running higher today following the initiation of a multiple-dose study using AM945.
During late-morning trade, shares in the Australian pharmaceutical company are up 7% to 29 cents.
Amplia is an Australian pharmaceutical company. The company is focusing on the development of Focal Adhesion Kinase (FAK) inhibitors for cancer and fibrosis. It's lead novel oral molecule, AMP945, is a "pure-play" inhibitor. This targets the formation of scar tissue (fibrosis) both in cancer and diseases such as idiopathic pulmonary fibrosis.
AMP945 is aimed at blocking FAK's activity which lessens scar tissue. Thus, AMP945 allows cancer treatments to be more effective without fibrosis.
What did Amplia announce?
The Amplia share price is on the move today. This comes after the report that it has progressed in the development of its novel inhibitor.
According to its release, Amplia advised that it has commenced a multiple ascending dose (MAD) study in its phase 1 clinical trial of AMP945. The decision to advance the FAK inhibitor was based on the positive results seen to date.
Amplia stated that during phase 1 trial, healthy volunteers undertook a single ascending dose (SAD) of AMP945. Patients were carefully monitored to gain a better understanding of the safety and tolerability parameters. As the initial study nears completion, it was revealed that no health issues were identified regarding the SAD administered to volunteers.
In light of the positive developments, Amplia decided to begin a MAD study involving 3 cohorts of subjects. The first lot of patients will be receiving their doses sometime this week. Different amounts will be administered to each group. The MAD study will run for a period of 7 days.
The data from both the SAD and MAD studies will help Amplia establish the desired dose of AMP945. This will be important for its future phase 2 clinical trial. Amplia is expecting that phase 2 will be commencing at the end of the 2021 calendar year.
Additionally, Amplia noted that it was also studying the impact of food on the absorption of AMP945. Amplia is currently analysing results after the separate trial concluded last month.
Words from the CEO
Amplia CEO, John Lambert, welcomed the company's progress, saying:
We are delighted that we have been able to advance AMP945 into our MAD study on the basis of the positive data seen so far in the SAD study. AMP945 is a very specific inhibitor of the FAK enzyme and has very little off-target activity. The excellent safety profile that we have seen in our SAD study to date is consistent with data from our preceding non-clinical studies.
We are very encouraged by the data that we have seen from the trial so far and look forward to reporting headline results from this Phase 1 clinical trial in Q2 2021.
About the Amplia share price
In the past 12 months, the Amplia shares have risen close to 200% reflecting positive investor sentiment. During March, its shares dipped to a 52-week low of 4.5 cents before storming higher to 37 cents in October.
Swapping hands for 29 cents today, the company's shares are only 25% away from its multi-year high.
