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A confirmatory study of CL2020 in patients with ST-elevation myocardial infarction

A confirmatory study of CL2020 in patients with ST-elevation myocardial infarction

86

Subjects aged more than 20 years with ST elevation AMI, presenting with reduced cardiac function (LVEF less than 45%) despite reperfusion by percutaneous coronary intervention (PCI)

Safety evaluation part: 3 subjects consented to participate in the study, received a single intravenous dose of CL2020 and completed the evaluation up to Week 52. Randomized part: 89 subjects consented to participate in the study. A total of 86 subjects were randomized to the CL2020 group (41 subjects) or the placebo group (45 subjects), and 41 subjects in the CL2020 group and 43 subjects in the placebo group received the study drug. 39 subjects in the CL2020 group and 43 subjects in the placebo group completed the evaluation up to Week 52.

Safety evaluation part: No adverse events or adverse drug reactions leading to death occurred. 1 serious adverse event (ventricular tachycardia) and 1 serious adverse drug reaction (ventricular tachycardia) occurred in 1 subject each. No significant adverse events or adverse drug reactions occurred. Randomized part: No adverse events or adverse drug reactions leading to death were reported. 11 SAEs occurred in 6 subjects in the CL2020 group (Inguinal hernia, cardiac failure, periodontitis, angina pectoris, cholecystitis, cardiac failure chronic, diabetes mellitus, chest discomfort, COVID-19, interstitial lung disease, small cell lung cancer) and 9 SAEs occurred in 4 subjects in the placebo group (Urinary tract infection, rectosigmoid cancer, stoma complication, peripheral arterial occlusive disease, lung mass, angina pectoris, large intestine polyp, ileus). Serious adverse reactions were reported only in the placebo group and included 1 event in 1 subject (rectosigmoid cancer). Neither adverse events nor adverse drug reactions leading to discontinuation of efficacy evaluation occurred.

The primary endpoint was not met because there was no statistically significant difference between the CL2020 group and the placebo group in the change from baseline in LVEF at Week 24 in echocardiography.

Safety evaluation part: Echocardiography showed an increase in LVEF after administration of CL2020, suggesting the possibility of improving left ventricular systolic function. In contrast, LVESV and LVEDV increased. The WMSI after CL2020 treatment remained almost unchanged up to Week 52. No left ventricular diastolic dysfunction was observed from baseline E/A and no change in E/A was observed after administration of CL2020. Randomized part: Cardiac function was evaluated by cardiac ultrasonography and cardiac SPECT, and LVESV, LVEDV, WMSI, infarct size, etc. were measured. However, no significant difference was observed in the changes between the CL2020 group and the placebo group, and the effect of CL2020 on cardiac function in patients with ST elevation acute myocardial infarction defined in this study was not clearly demonstrated.

Following a single intravenous administration of CL2020 or placebo to patients with ST elevation acute myocardial infarction, the change from baseline in LVEF at Week 24 on echocardiography was not statistically significantly different between the CL2020 group and the placebo group, failing to meet the primary endpoint. There were no safety concerns with administration of CL2020.

Aug. 10, 2023

No

Fukushima Tatsunobu

Life Science Institute Inc.

1-1 Marunouchi 1-chome, Chiyoda-ku, Tokyo 100-8251

lsii.chiken-inq@eppharmaline.co.jp

call center

Life Science Institute Inc.

1-1 Marunouchi 1-chome, Chiyoda-ku, Tokyo 100-8251

+81-3-6748-7200

lsii.chiken-inq@eppharmaline.co.jp

completed

Dec. 10, 2019

Interventional

A multicenter, randomized, double-blind, parallel-group study

treatment purpose

2-3

-Patients diagnosed ST-elevation myocardial infarction
-Patients with cardiac dysfunction in spite of successful reperfusion by PCI

-Patients with any existing or previous malignant tumor
-Pregnant or nursing women, or women of child-bearing potential

Both

ST-elevation myocardial infarction

investigational material(s)
Generic name etc : CL2020
INN of investigational material : -
Therapeutic category code : 49- Other agents affecting cellular function
Dosage and Administration for Investigational material : intravenous infusion

control material(s)
Generic name etc : Placebo
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : intravenous infusion

efficacy
Left ventricular ejection fraction after infusion of CL2020

efficacy
left ventricular end-systolic volume and left ventricular end-diastolic volume after infusion of CL2020 etc.

Nov. 25, 2019

Nov. 25, 2019