AstraZeneca reports data from two sub-studies for antiplatelet drug AZD6140

By Elaine Rigoli

Tampa, Fla., March 13 - New phase 2b data unveiled on Monday reported effects of the AstraZeneca investigational antiplatelet drug AZD6140 on inhibition of platelet aggregation compared to clopidogrel in patients with non-ST elevation acute coronary syndromes (NSTE-ACS).

AZD6140 is proposed to work by inhibiting the aggregation of platelets in the blood. The two sub-studies were part of the Disperse2 study, which assessed the safety and tolerability of AZD6140 plus aspirin compared with clopidogrel plus aspirin in patients with NSTE-ACS, according to a news release.

AZD6140 is being studied as the first reversible oral adenosine diphosphate (ADP) receptor antagonist for acute coronary syndromes. It is proposed to selectively inhibit the P2Y12 receptor, a key target receptor for ADP on platelets, the release said.

The first sub-study, involving 45 patients, assessed the platelet inhibitory effect of administering AZD6140 in patients not previously treated with clopidogrel (clopidogrel-naive). The primary measure of this sub-study was final extent ADP-induced platelet aggregation, which is a recognized methodology for evaluating the effect of a drug on platelets.

On day 1, after the first dose, the mean inhibition of platelet aggregation at two hours was 66% for the AZD6140 90 mg group, 80% for the AZD6140 180 mg group and 82% for the AZD6140 270 mg group versus 22% for the clopidogrel 300 mg group.

The subsequent four, eight and 12-hour time points assessed on day 1 showed similar effects. At week four, at the pre-dose through 12-hour time points assessed, the mean inhibition of platelet aggregation for the AZD6140 180 mg twice-daily dosing group was 87%-95% versus 52%-64% inhibition of platelet aggregation for the clopidogrel 75 mg group, while mean inhibition of platelet aggregation for the AZD6140 90 mg twice-daily dosing group was 73%-79%.

The second sub-study, involving 44 patients, assessed the effect on platelets of administering AZD6140 in patients who received clopidogrel prior to entry into the study. The primary measure of this sub-study was final extent platelet aggregation as measured prior to study drug dosing and at two, four, eight and 12 hours after AZD6140 or clopidogrel administration on day 1.

Mean platelet aggregation prior to dosing was AZD6140 90 mg 48%, AZD6140 180 mg 34%, AZD6140 270 mg 43% and clopidogrel 75 mg 38%.

In the clopidogrel-only group, the mean decrease in platelet aggregation across time points ranged from 2% to 11% while the mean decrease in platelet aggregation was 37%-38% for the AZD6140 90 mg group, 28%-32% for the AZD6140 180 mg group and 34%-42% for the AZD6140 270 mg group.

AstraZeneca, with headquarters in Wilmington, Del., is an international health care business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of health care services.

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