New York autoimmune biotech Immunovant has voluntarily stopped ongoing trials for its experimental drug IMVT-1401.
The drug, which works as a fully human monoclonal antibody targeting the neonatal Fc receptor, is being tested across a series of trials in myasthenia gravis (MG), thyroid eye disease (TED) and warm autoimmune hemolytic anemia (WAIHA).
But in a phase 2b of the drug in TED, Immunovant said it had “become aware of a physiological signal consisting of elevated total cholesterol and LDL levels in IMVT-1401-treated patients” in the so-called ASCEND GO-2 trial.
It doesn’t know whether cholesterol levels were higher in the MG test, as it was not measured in these. It adds that Harbour BioMed, the license holder for the drug in greater China, also checked over the data in their ongoing clinical studies in Chinese patients with MG and idiopathic thrombocytopenic purpura but found that similar increases in cholesterol “have not been observed.”
But given this safety signal and “out of an abundance of caution,” Immunovant is going to voluntarily pause dosing in ongoing clinical studies in both TED and WAIHA “in order to inform patients, investigators, and regulators as well as to modify the monitoring program,” it said in a statement.
Sharing the data, the biotech said preliminary, unblinded data from about 40 patients through Week 12 saw mean LDL cholesterol jump 65% in the 680-mg dose group and by around 40% in the lower 340-mg dose group, but it did not increase in the control group.
“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.”
The company’s shares were more than halved on the news in Tuesday morning trading.