- Plan to provoke a Pivotal Phase 2b trial in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) within the second half of 20221 with preliminary outcomes from open-label interval 1 anticipated within the first half of 2024
- Plan to provoke a Phase 2 trial in Graves’ Disease in early 2023 with preliminary outcomes anticipated within the second half of 2023
- Immunovant expects a sturdy cadence of knowledge each half 12 months starting within the second half of 2023 by the primary half of 2025, together with a number of medical readouts in CIDP, Graves’ Disease, Myasthenia Gravis (MG), and Thyroid Eye Disease (TED)
- Company administration will host an investor webcast immediately at 8 AM ET that may be accessed right here.
NEW YORK, Sept. 07, 2022 (GLOBE NEWSWIRE) — Immunovant, Inc. (Nasdaq: IMVT), a clinical-stage biopharmaceutical firm targeted on enabling regular lives for folks with autoimmune illnesses, immediately introduced plans to develop batoclimab in Chronic Inflammatory Demyelinating Polyneuropathy and Graves’ Disease.
“We are excited 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,” stated Pete Salzmann, M.D., Chief Executive Officer of Immunovant. “Evidence suggests that both CIDP and Graves’ Disease are caused by autoantibodies and that targeting FcRn is a compelling therapeutic strategy. We believe both indications present promising opportunities ripe for innovation.”
“CIDP represents a multibillion-dollar market for IVIG and a compelling opportunity for the anti-FcRn class, as current therapies for this complex disease have meaningful safety, tolerability and logistical limitations. We have designed our pivotal Phase 2b study leveraging learnings from historical and ongoing clinical trials in this disease, with a goal to improve probability of success and effect size, while studying multiple doses for optimal differentiation,” added Bill Macias, M.D., Chief Medical Officer at Immunovant.
“With regard to Graves’ Disease, current treatments leave a meaningful proportion of patients unable to achieve normal thyroid hormone function and many remain symptomatic even when on current therapies”, stated Dr Salzmann. “As a classic autoantibody condition, the straightforward biology of Graves’ Disease, from pathogenic autoantibody to altered hormones, provides solid scientific rationale for the indication, supported by anecdotal data from our Thyroid Eye Disease Phase 2b trial. By further defining the dose-response for batoclimab in Graves’ Disease, we believe our Graves’ Phase 2 trial, if successful, can meaningfully inform and de-risk a future Phase 3 trial and help bring a novel therapy to a large patient population that requires additional treatment.”
With the addition of those growth packages, Immunovant is now pursuing batoclimab’s medical growth in 5 indications, together with MG and TED which have beforehand disclosed information readouts. Immunovant plans to finalize its trial design in Warm Autoimmune Hemolytic Anemia following interactions with regulators later in 2022.
Investor Webcast
Immunovant will host an investor webcast immediately at 8 AM ET. The webcast will function ready remarks by firm administration and exterior key opinion leaders and can spotlight the present therapy panorama for CIDP and Graves’ Disease, in addition to plans to check batoclimab’s potential to deal with the unmet wants in its goal affected person populations. A stay question-and-answer session with firm administration will comply with the formal shows.
Featured audio system will embrace:
- George Kahaly, MD, PhD, Professor of Medicine and Endocrinology / Metabolism on the Johannes Gutenberg University (JGU) Medical Center
- Jonathan Katz, MD, Director, Neuromuscular Clinic, California Pacific Medical Center
- Todd Levine, MD, Medical Director, Neurology Department, Honor Health Scottsdale, Arizona
To entry the webcast, please register right here. An archived recording of the webcast will probably be out there on Immunovant’s web site for a restricted time following its conclusion.
About Immunovant, Inc.
Immunovant, Inc. is a clinical-stage biopharmaceutical firm devoted to enabling regular lives for folks with autoimmune illnesses. As a pacesetter in FcRn inhibitor know-how, the Company is boldly creating modern therapies for a variety of debilitating autoimmune illnesses with important unmet affected person wants. The Company’s investigational compound, batoclimab, is a novel, totally human, monoclonal antibody focusing on the neonatal Fc receptor (FcRn). For extra info on the Company, please go to www.immunovant.com.
Forward Looking Statement
This press launch accommodates forward-looking statements for the needs of the protected harbor provisions below The Private Securities Litigation Reform Act of 1995 and different federal securities legal guidelines. The use of phrases corresponding to “can,” “may,” “might,” “will,” “would,” “should,” “expect,” “believe,” “estimate,” “design,” “plan,” “intend,” and different related expressions are meant to establish forward-looking statements. Such forward-looking statements embrace Immunovant’s plan to provoke a Phase 2b medical trial for batoclimab in CIDP within the second half of calendar 12 months 2022 with preliminary outcomes from open-label interval 1 anticipated within the first half of calendar 12 months 2024; Immunovant’s plan to provoke a Phase 2 medical trial for batoclimab in Graves’ Disease in early calendar 12 months 2023 with preliminary outcomes anticipated within the second half of calendar 12 months 2023; Immunovant’s plan to finalize its trial design in Warm Autoimmune Hemolytic Anemia following anticipated interactions with regulators later in calendar 12 months 2022; Immunovant’s plan to develop batoclimab throughout a broad vary of different autoimmune indications; the timing of discussions with regulatory companies; the scale and development of the potential markets for Immunovant’s product candidate and indication picks; Immunovant’s expectations relating to timing, the design and outcomes of medical trials of its product candidates and indication picks; and the potential advantages of batoclimab’s distinctive product attributes. All forward-looking statements are primarily based on estimates and assumptions by Immunovant’s administration that, though Immunovant believes to be affordable, are inherently unsure. All forward-looking statements are topic to dangers and uncertainties that will trigger precise outcomes to vary materially from those who Immunovant anticipated. Such dangers and uncertainties embrace, amongst others: preliminary outcomes or different preliminary analyses or outcomes of early medical trials will not be predictive ultimate trial outcomes or of the outcomes of later medical trials; the timing and availability of knowledge from medical trials; the timing of discussions with regulatory companies, in addition to regulatory submissions and potential approvals; the continued growth of Immunovant’s product candidate, together with the timing of the graduation of extra medical trials; Immunovant’s scientific strategy, medical trial design, indication choice and normal growth progress; future medical trials could not affirm any security, efficiency or different product traits described or assumed on this press launch; any product candidate that Immunovant develops could not progress by medical growth or obtain required regulatory approvals inside anticipated timelines or in any respect; Immunovant’s product candidate will not be useful to sufferers, or even when accepted by regulatory authorities, efficiently commercialized; the potential impression of the continued COVID-19 pandemic, geopolitical tensions, and antagonistic macroeconomic situations on Immunovant’s medical growth plans and timelines; Immunovant’s business is closely depending on the profitable growth, regulatory approval and commercialization of its sole product candidate, batoclimab; Immunovant is at an early stage in growth of batoclimab; and Immunovant would require extra capital to fund its operations and advance batoclimab by medical growth. These and different dangers and uncertainties are extra totally described in Immunovant’s periodic and different studies filed with the Securities and Exchange Commission (SEC), together with within the part titled “Risk Factors” in Immunovant’s most up-to-date Annual Report on Form 10-Ok, its Form 10-Q filed with the SEC on August 5, 2022, and Immunovant’s subsequent filings with the SEC. Any forward-looking assertion speaks solely as of the date on which it was made. Immunovant undertakes no obligation to publicly replace or revise any forward-looking assertion, whether or not because of new info, future occasions or in any other case.
Contact:
Tom Dorney, MS, MBA
Director, Investor Relations & Strategy
Immunovant, Inc.
[email protected]
__________________
- All dates discuss with calendar 12 months
