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Immunovant (NASDAQ: IMVT) shares are plummeting on Tuesday after the clinical-stage biopharmaceutical company announced a voluntary pause of dosing in its ongoing clinical trials for IMVT-1401.
The company revealed it became aware of a physiological signal consisting of elevated total cholesterol and LDL levels in patients treated with IMVT-1401 in its ASCEND GO-2 Phase 2B trial in thyroid eye disease.
Cholesterol levels were not measured before clinical trials. The company said that out of an abundance of caution, it decided to voluntarily pause dosing in ongoing clinical studies in both thyroid eye disease and warm autoimmune hemolytic anaemia to inform patients investigators and regulators and modify the monitoring program.
The ASCEND GO-2 trial was randomised and placebo-controlled in thyroid eye disease, evaluating different doses each given weekly for 12 weeks. Cholesterol parameters were assessed at baseline, at 12 weeks, and at week 20, following 8 weeks off the drug.
Elsewhere Harbour BioMed, the license holder for IMVT-1401 in Greater China, informed Immunovant that based on its preliminary review of blinded data in their ongoing clinical studies in Chinese patients with MG and Idiopathic Thrombocytopenic Purpura, similar increasing cholesterol have not been observed.
Immunovant will now work closely with regulators and other scientific experts to characterise the detailed profile of these changes and understand the mechanism. Once discussed and agreed with regulators, the company said it intends to continue to pursue the development of IMVT-1401.
Immunovant shares are one of the biggest losers so far on Tuesday, down 38.59% at $26.59.
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