Elevated cholesterol and low-density cholesterol levels
(Seoul = Yonhap News) Reporter Gye Seung-Hyun = Hanall Bio Pharma[009420]Announced on the 3rd that global partner Immunobant temporarily suspended the clinical trial due to the rise in total cholesterol and low-density cholesterol (LDL) levels of patients who took’IMVT-1401′ in phase 2b clinical trial for thyroid ophthalmopathy (TED).
Immunobant is discontinuing medications for TED and the warm antibody hemolytic anemia (WAIHA) to inform patients, researchers and regulators of this and to modify its clinical monitoring programme.
This phase 2b trial is a randomized placebo-controlled trial that evaluates efficacy and safety by administering IMVT-1401 at high (680 mg) and low (340 mg) doses to TED patients. Each was administered for 12 weeks.
In this study, cholesterol-related variables were measured at the time of dosing, 12 weeks at the end of dosing, and at 20 weeks after the end of dosing.
Preliminary data obtained from about 40 patients showed that at week 12, LDL levels increased by about 65% in the 680 mg dose group and about 40% in the 340 mg dose group, but did not increase in the placebo group.
Average levels of high-density cholesterol (HDL) and triglycerides increased slightly.
However, the company said that at 20 weeks after the end of the medication, the average LDL level decreased to or below the baseline in both dose groups, and the LDL increase caused by IMVT-1401 was temporary.
No serious cardiovascular adverse events were observed during the clinical course.
Hanall Biopharma was notified that such an increase in cholesterol was not observed in the clinical trials for severe myasthenia and idiopathic thrombocytopenia by Chinese partner Harbor Biomed.
Immunobant will continue clinical development of IMVT-1401 by analyzing the pattern of changes in cholesterol levels with experts and regulatory agencies, confirming the mechanism of change, and then changing the clinical protocol.
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2021/02/03 10:41 sent