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Immunovant Provides Corporate Updates and Reports Financial Results for the Fourth Quarter and Fiscal Year Ended March 31, 2023
Investigational New Drug (IND) application and Clinical Trial Application (CTA) for IMVT-1402 cleared by the FDA and MEDSAFE, respectivelyPhase 1 clinical
About this update from Immunovant, Inc.
[{"type":"text","content":"Investigational New Drug (IND) application and Clinical Trial Application (CTA) for IMVT-1402 cleared by the FDA and MEDSAFE, respectivelyPhase 1 clinical trial in healthy subjects initiated in New ZealandPhase 2 proof-of-concept clinical trial of batoclimab in Graves’ disease (GD) initiated in GermanyGlobal clinical trials of batoclimab are ongoing in myasthenia gravis (MG), thyroid eye disease (TED), and chronic inflammatory demyelinating polyneuropathy (CIDP) NEW YORK, May 22, 2023 (GLOBE NEWSWIRE) -- Immunovant, Inc. (Nasdaq: IMVT), a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases, today reported corporate updates and financial results for its fiscal fourth quarter and fiscal year ended March 31, 2023. “During the past quarter, we made significant progress with IMVT-1402, including receiving the IND clearance by the FDA, and the initiation of a Phase 1 clinical trial following the approval by MEDSAFE to proceed,” said Pete Salzmann, M.D., chief executive officer at Immunovant. “This is an important step as we seek to expeditiously generate Phase 1 data and accelerate a global development program for IMVT-1402.” Clinical Development Updates:IMVT-1402:Immunovant received IND clearance for IMVT-1402 from the U.S. Food and Drug Administration (FDA) and initiated a Phase 1 clinical trial of IMVT-1402 in healthy volunteers in New Zealand after approval of the CTA by the regulatory authority, MEDSAFE. The clinical trial will evaluate the safety, tolerability and pharmacodynamic profiles of IMVT-1402, a subcutaneously administered, FcRn inhibitor. In the multiple-ascending dose (MAD) portion of the study, Immunovant plans to evaluate subcutaneous doses of 300 mg and 600 mg, at a concentration of 150 mg/mL vs. placebo. Initial data from single-ascending dose cohorts are expected in August/September 2023 and initial data from MAD cohorts are expected in October/November 2023. In a head-to-head, placebo-controlled nonclinical study, IMVT-1402 has been observed to achieve similarly deep IgG reduction as batoclimab and have minimal or no impact on levels of albumin and low-density lipoprotein cholesterol at doses well above the anticipated human effective dose. Immunovant believes this profile could be best in class. Batoclimab:A Phase 2 proof-of-concept clinical trial of batoclim...