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February 2 , 2021 IMMUNOVANT® Immunovant Announces Voluntary Pause in Clinical Dosing of IMVT - 1401 NEW YORK , Feb. 02 , 2021 ( GLOBE NEWSWIRE ) -- Immunovant ( Nasdaq : IMVT ) , a clinical- stage biopharmaceutical company focused on enabling normal lives for patients with autoimmune diseases , today announced a voluntary pause of dosing in its ongoing clinical trials for IMVT - 1401 . The Company has become aware of a physiological signal consisting of elevated total cholesterol and LDL levels in IMVT - 1401 - treated patients in ASCEND GO - 2 , a Phase 2b trial in Thyroid Eye Disease ( TED ) . Cholesterol levels were not measured in prior clinical trials of IMVT - 1401 in Myasthenia Gravis ( MG ) and in healthy subjects . Out of an abundance of caution , the Company has decided to voluntarily pause dosing in ongoing clinical studies in both TED and in Warm Autoimmune Hemolytic Anemia , in order to inform patients , investigators , and regulators as well as to modify the monitoring program . ASCEND GO - 2 is a randomized , placebo - controlled trial in TED evaluating different doses , each given weekly for 12 weeks . In this study , cholesterol parameters are assessed at baseline , at twelve weeks , and at week 20 following eight weeks off drug . Based on preliminary , unblinded data from about 40 patients through week 12 , mean LDL cholesterol at week 12 was increased by approximately 65 % in the 680mg dose group , by approximately 40 % in the 340mg dose group , and did not increase in the control group . Average HDL and triglyceride levels increased to a much lesser degree . For context , commercially available statins report a reduction in LDL cholesterol between 27-60 % . At the twenty - week timepoint , average LDL levels had declined to baseline or lower in the 680mg dose group , in the 340mg dose group , and in the control group . No serious cardiovascular events have been reported to date in IMVT - 1401 clinical trials . Harbour BioMed , the license holder for 1401 in Greater China , has informed Immunovant that based on their preliminary review of blinded data in their ongoing clinical studies in Chinese patients with MG and Idiopathic Thrombocytopenic Purpura , similar increases in cholesterol have not been observed . The Company is not aware whether trials involving other anti - FcRn agents in development have performed detailed assessments of lipid parameters . The Company will work closely with regulators and scientific experts to characterize the detailed profile of these lipid changes and to understand the mechanism of these changes across indications . After discussion and agreement with regulators regarding protocol modifications , the Company intends to continue to pursue development of IMVT - 1401 . Immunovant will host a conference call on Tuesday , February 2 at 8:00 am EST . Following prepared remarks , the call will include a live question - and - answer session for the investment community . To access the webcast , please visit Immunovant's website at www.immunovant.com . Participants may also dial in using the numbers provided below :