Hanall Biopharma said Wednesday that Immunovant, its U.S. partner, has recently decided to resume the clinical trial of HL161, an autoimmune disease treatment.
In February, Immunovant voluntarily suspended the clinical trials of HL161, known as IMVT-1401 in the U.S., due to an increase in cholesterol levels.
The U.S. company halted phase 2b clinical trials for treating thyroid eye disease (TED) after observing physiological signals, including an unexpected rise of low-density lipoprotein (LDL) levels in patients administered with IMVT-1401.
As a result of a comprehensive analysis of related clinical data, however, Immunovant confirmed that LDL was consistently proportional to the dose usage in several clinical trials and associated with decreased albumin levels.
The company also confirmed that LDL and albumin levels normalized upon stopping the drug’s use. Among the clinical participants, the increase in LDL was insignificant in patients taking statins.
Based on a detailed analysis of the patient group participating in the clinical trial, Immunovant determined that it could strengthen patient monitoring and manage them safely, according to a press release Wednesday.
The company plans to change the dosing method and cycle and, if necessary, prescribe statin-based drugs to participants.
“While both the 340mg and 680mg weekly doses demonstrated substantial reductions in immunoglobulin G (IgG), the 255mg dose also achieved significant IgG reductions but without the same extent of undesired reductions in albumin or related increases in LDL,” Immunovant CEO Pete Salzmann said. “These results present an opportunity for flexibility in dosing, dose intervals, and a lower-volume injection to explore in the company’s future clinical trials.”
Salzmann stressed that following a program-wide data review, the company remains confident in its plan to develop IMVT-1401 across a broad range of autoimmune indications.
“We look forward to constructive dialogue with regulatory agencies and plan to resume clinical development of IMVT-1401, including in a potentially pivotal trial in Myasthenia Gravis and a phase 2 study of warm autoimmune hemolytic anemia in late 2021 or early 2022,” he said. “We also plan to initiate two additional studies in the next 12 months after discussions with regulators.”
Despite the Immunovant resuming clinical trials, Hanall Biopharma’s shares continued to take a nosedive on Wednesday. As of 2:30 p.m., the company’s shares stood at 20,950 won ($18.83), down 7.91 percent from the previous trading day.