Immunovant, a clinical-stage biopharmaceutical company, announced yesterday that it has initiated dosing in ASCEND-GO 1, an open label, single-arm Phase 2a clinical trial evaluating IMVT-1401 in patients with moderate-to-severe active Graves' ophthalmopathy (GO). IMVT-1401 is a novel, fully human monoclonal antibody that selectively binds and inhibits the neonatal Fc receptor (FcRn) and is designed to be delivered by subcutaneous injection.
In the ASCEND-GO 1 trial, an expected eight patients will receive six weekly subcutaneous injections of IMVT-1401: 680 mg for the first two administrations, followed by 340 mg for the final four administrations. The primary endpoints for this clinical trial are safety and tolerability. Changes from baseline in levels of anti-TSHR antibodies, total IgG antibodies and IgG antibody subclasses will also be measured. This trial has been designed without use of any intravenous induction dosing. Immunovant also expects to initiate ASCEND-GO 2, a randomized, dose-ranging Phase 2b clinical trial evaluating IMVT-1401 in patients with GO, later this quarter. GO is a serious and disfiguring disease, potentially resulting in blindness. There are no FDA-approved therapies for GO today.
"We believe that IMVT-1401, by depleting the autoantibodies that cause Graves' ophthalmopathy, may offer a targeted treatment option for patients. In addition, IMVT-1401 is designed to be delivered in a convenient subcutaneous injection, avoiding the need for intravenous infusions. We look forward to gaining further insights from the Phase 2 ASCEND-GO program," said Sandeep C. Kulkarni, Chief Operating Officer of Immunovant.
For more information about this clinical trial, please visit www.clinicaltrials.gov. The clinicaltrials.gov identifier is NCT03922321.
News source: https://www.prnewswire.com/news-releases/immunovant-initiates-dosing-in-ascend-go-1-a-phase-2a-trial-of-imvt-1401-in-patients-with-graves-ophthalmopathy-go-300855556.html