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Immunovant Announces Positive Clinical Results from Ongoing Phase 2a Proof-of-Concept Study of IMVT-1401, A Novel Investigational Anti-FcRn Antibody Delivered by Subcutaneous Injection, in Thyroid Eye Disease
Company to Host Conference Call on March 30, 2020 at 8:30am EDT 65% mean reduction in total IgG was observed from baseline to end of treatment, with a
About this update from Immunovant, Inc.
[{"type":"text","content":"Company to Host Conference Call on March 30, 2020 at 8:30am EDT\n 65% mean reduction in total IgG was observed from baseline to end of treatment, with a pharmacodynamic (PD) response nearly identical to modeled predictions for dosing regimen tested in trialIMVT-1401 was safe and generally well-tolerated with no serious adverse events (SAEs), no withdrawals due to adverse events (AEs), and no headaches4/7 patients (57%) improved by ≥ 2 points on the Clinical Activity Score (CAS) and 3/7 patients (43%) achieved a proptosis responseResults establish first proof of concept for an anti-FcRn antibody in Thyroid Eye Disease NEW YORK, March 30, 2020 (GLOBE NEWSWIRE) -- Immunovant, Inc. (NASDAQ: IMVT), a clinical-stage biopharmaceutical company focused on enabling normal lives for patients with autoimmune disease, today announced initial results from the treatment phase of its ongoing Phase 2a study of IMVT-1401 (ASCEND GO-1) in patients with Thyroid Eye Disease (TED), also known as Graves’ ophthalmopathy. The multi-center, open-label, single-arm clinical trial evaluated two weekly 680mg subcutaneous doses of IMVT-1401 followed by four weekly 340mg subcutaneous doses of IMVT-1401 in seven adult patients with moderate-to-severe active TED. A planned eighth patient enrolled in ASCEND GO-2 instead of ASCEND GO-1. All patients in the trial have completed IMVT-1401 treatment and have entered the follow-up phase of the trial. Mean reduction in total IgG levels from baseline to end of treatment was 65%. As evaluated at the end of treatment, 4/7 patients (57%) improved by ≥ 2 points on the Clinical Activity Score (CAS). Of six patients with baseline diplopia, 4/6 patients (67%) demonstrated improvement in diplopia. 3/7 patients (43%) were proptosis responders. The safety and tolerability profile observed was consistent with the prior Phase 1 trial of IMVT-1401 in 99 healthy volunteers. All AEs were mild or moderate and there were no headaches reported. “We are very excited by the initial results of this trial,” said Pete Salzmann, M.D., Chief Executive Officer of Immunovant. “These results provide an early proof-of-concept of the potential for IMVT-1401 to ultimately become a safe and effective treatment for patients suffering from Thyroid Eye Disease. Importantly, IMVT-1401 was delivered by subcutaneous injection, opening the possibility of at-...