IMVT News
Surprised we didn't bounce a little with this news of discontinuing their trial....
As part of the company’s data review, the Ph 2b TED study was unblinded and terminated prior to completion. While the trial showed clear biologic activity based on changes in IgG and pathologic autoantibodies, prematurely terminating the study resulted in inconclusive efficacy results. Forty-one subjects out of a planned seventy-seven reached the twelve-week primary endpoint. Efficacy data in this underpowered subset was more modest than the company had hoped and was not statistically significant on the primary endpoint. However, biologic effects, including a relationship between auto-antibodies and disease activity were observed that the company feels are encouraging with respect to treating TED. Immunovant plans to work with regulators and key opinion leaders on a design for a subsequent study and believes a phase 2 trial rather than a pivotal study is likely to be the appropriate next step in the development of IMVT-1401 in this therapeutic area