Immunovant announces two new development programs for
- Plan to initiate a pivotal Phase 2b trial in chronic inflammatory demyelinating polyneuropathy (CIDP) in the second half of 20221 with first open period 1 results expected in the first half of 2024
- Plan to initiate a phase 2 trial in Graves’ disease in early 2023 with first results expected in the second half of 2023
- Immunovant expects a robust cadence of data each semester from the second half of 2023 through the first half of 2025, including multiple clinical readouts in CIDP, Graves’ disease, myasthenia gravis (MG), and thyroid eye disease (TED)
- Company management will host a webcast for investors today at 8 a.m. ET, accessible here.
NEW YORK, Sept. 07, 2022 (GLOBE NEWSWIRE) — Immunovant, Inc. (Nasdaq: IMVT), a clinical-stage biopharmaceutical company focused on enabling normal life for people with autoimmune diseases, today announced plans to develop batoclimab in chronic inflammatory demyelinating polyneuropathy and Graves’ disease. .
“We are delighted to announce the addition of two new target indications for batoclimab, one of which will be a pivotal program, confirming our confidence in the broad development opportunity for batoclimab,” said Pete Salzmann, MD, Chief Executive Officer. of Immunovant. “Evidence suggests that CIDP and Graves’ disease are caused by autoantibodies and that targeting FcRn is a compelling therapeutic strategy. We believe that both indications present promising opportunities ripe for innovation.
“CIDP represents a multi-billion dollar market for IVIG and a compelling opportunity for the anti-FcRn class, as current therapies for this complex disease have significant safety, tolerability and logistical limitations. We designed our pivotal Phase 2b study by leveraging insights from historic and ongoing clinical trials in this disease, with the goal of improving the likelihood of success and size of effect, while investigating multiple doses for optimal differentiation,” added Bill Macias, MD, Chief Medical Officer. at Immunovant.
“With respect to Graves’ disease, current treatments leave a significant proportion of patients unable to achieve normal thyroid hormone function and many remain symptomatic even under current treatments,” Dr. Salzmann said. “As a classic autoantibody condition, the simple biology of Graves’ disease, from pathogenic autoantibodies to altered hormones, provides strong scientific rationale for the indication, supported by anecdotal data from our trial of phase 2b on thyroid eye disease. By more precisely defining the dose-response of batoclimab in Graves’ disease, we believe that our Graves Phase 2 trial, if successful, can inform and significantly reduce the risks of a future Phase 3 trial and help bring new therapy to a large patient population that requires additional treatment.
With the addition of these development programs, Immunovant is now pursuing the clinical development of batoclimab in five indications, including MG and TED which have already disclosed data readouts. Immunovant expects to finalize its trial design in warm autoimmune hemolytic anemia following interactions with regulators later in 2022.
Webcast for investors
Immunovant will host a webcast for investors today at 8 a.m. ET. The webcast will feature prepared remarks from company management and key external opinion leaders and highlight the current treatment landscape for CIDP and Graves’ disease, as well as plans to study the potential of batoclimab. to meet the unmet needs of its target patient populations. A live Q&A with company management will follow the official presentations.
Guest speakers will include:
- George Kahaly, MD, PhD, Professor of Medicine and Endocrinology/Metabolism at Johannes Gutenberg University Medical Center (JGU)
- Jonathan Katz, MD, Director, Neuromuscular Clinic, California Pacific Medical Center
- Todd Levine, MD, Medical Director, Department of Neurology, Honor Health Scottsdale, Arizona
To access the webcast, please register here. An archived recording of the webcast will be available on Immunovant’s website for a limited time after its conclusion.
About Immunovant, Inc.
Immunovant, Inc. is a clinical-stage biopharmaceutical company dedicated to enabling normal life for people with autoimmune diseases. As a leader in FcRn inhibitor technology, the company is boldly developing innovative therapies for a range of debilitating autoimmune diseases with significant unmet patient needs. The Company’s investigational compound, batoclimab, is a novel fully human monoclonal antibody targeting the neonatal Fc receptor (FcRn). For more information about the company, please visit www.immunovant.com.
This press release contains forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as “may”, “could”, “could”, “will”, “would”, “should”, “expect”, “believe”, “estimate”, “conceive”, “plans”, “intends” and other similar expressions are intended to identify forward-looking statements. These forward-looking statements include Immunovant’s plan to initiate a Phase 2b clinical trial for batoclimab in CIDP in the second half of calendar year 2022, with early open-label Period 1 results expected in the first semester of calendar year 2024; Immunovant’s plan to initiate a Phase 2 clinical trial for batoclimab in Graves’ disease in early calendar year 2023 with initial results expected in the second half of calendar year 2023; Immunovant’s plan to finalize its trial design in warm autoimmune hemolytic anemia following expected interactions with regulators later in calendar year 2022; Immunovant’s plan to develop batoclimab in a wide range of other autoimmune indications; timing of discussions with regulators; the size and growth of potential markets for Immunovant’s product candidate and indication selections; Immunovant’s expectations regarding the timing, design and results of clinical trials of its product candidates and indication selections; and the potential benefits of the unique features of the batoclimab product. All forward-looking statements are based on estimates and assumptions of Immunovant’s management which, although Immunovant believes to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those Immunovant expected. These risks and uncertainties include, among others: initial results or other preliminary analyzes or early clinical trial results may not be predictive of final trial results or subsequent clinical trial results; the timing and availability of clinical trial data; timing of discussions with regulators, as well as potential regulatory submissions and approvals; the further development of Immunovant’s product candidate, including the timing of commencement of additional clinical trials; Immunovant’s scientific approach, clinical trial design, selection of indications and general development progress; future clinical trials may not confirm the safety, potency or other product characteristics described or implied in this press release; any product candidates developed by Immunovant may not progress through clinical development or receive required regulatory approvals on time or at all; Immunovant’s product candidate may not benefit patients, or even if approved by regulatory authorities, be successfully marketed; the potential impact of the ongoing COVID-19 pandemic, geopolitical tensions and adverse macroeconomic conditions on Immunovant’s clinical development plans and schedules; Immunovant’s business is highly dependent on the successful development, regulatory approval and commercialization of its sole product candidate, batoclimab; Immunovant is in an early stage of batoclimab development; and Immunovant will need additional capital to fund its operations and advance batoclimab through clinical development. These and other risks and uncertainties are more fully described in Immunovant’s periodic and other reports filed with the Securities and Exchange Commission (SEC), including in the section entitled “Risk Factors” of the latest Immunovant’s annual report on Form 10-K, its Form 10-Q filed with the SEC on August 5, 2022, and Immunovant’s subsequent filings with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Immunovant undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Tom Dorney, MS, MBA
Director, Investor Relations and Strategy