Temporary spikes in cholesterol
Normal recovery after 20 weeks of clinical trial
US company “to re-weave clinical structure”
The clinical trials of the autoimmune disease treatment that Hanall Biopharma has exported to the US Immunobant have been completely suspended. This is because there was a side effect of patients’ cholesterol levels rising by more than 60% during the clinical process. Immunobant plans to rewrite its clinical structure.
Immunobant announced on the 2nd (local time) that it will stop clinical trials of HL161, an autoimmune disease treatment that is being developed as a treatment for thyroid eye disease (TED) and warm antibody hemolytic anemia (WAIHA). HL161 is currently undergoing phase 2b and phase 2a clinical trials in the United States for indications for thyroid ophthalmopathy and warm antibody hemolytic anemia. It is a drug that Hanall Biopharma, a subsidiary of Daewoong Pharmaceutical, transferred its exclusive rights to regions excluding Asia and Oceania in December 2017 for a down payment of 30 million dollars (about 33 billion won) and a total of 500 million dollars (about 550 billion won). Immunobant is a NASDAQ-listed company, and the drug is the only drug candidate (pipeline).
Immunobant revealed that total cholesterol and low-density lipoprotein (LDL) cholesterol levels in the HL161 group were elevated during the clinical course of thyroid ophthalmopathy patients. Immunobant administered HL161 once a week for 12 weeks to 40 patients and observed for 8 weeks. The mean LDL cholesterol increased by about 65% in the 680 mg administration group up to 12 weeks. In the half-dose 340 mg dose group, it increased by about 40%. The 255 mg group increased by 25% and the placebo group showed no change in cholesterol levels.
Immunobant said that eight weeks after completing the HL161 administration, that is, 20 weeks after the start of the administration, cholesterol levels returned to normal. Temporary increases in numbers are explanation
A company official said, “It is true that an unexpected side effect occurred,” and said, “This phenomenon occurred in the patients with thyroid ophthalmopathy, but the cause was not identified, so clinical trials for the patients with warm antibody hemolytic anemia are also stopped.”
HL161 is a new drug with a new mechanism of action that relieves the symptoms of disease by promoting intracellular degradation of pathogenic autoantibodies that cause autoimmune diseases. Autoimmune diseases caused by pathogenic antibodies are classified into more than 70 diseases according to the attacked body part or condition.
Reporter Kim Woo-seop [email protected]
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