Immunovant Reports Positive Initial Phase 2 Results for Batoclimab in Graves’ Disease
December 20 2023 - 4:30PM
Immunovant, Inc. (Nasdaq: IMVT), a clinical-stage
immunology company dedicated to enabling normal lives for people
with autoimmune diseases, today announced that results from the
initial cohort of patients in an ongoing 24-week Phase 2 clinical
trial of batoclimab in patients with Graves’ disease meaningfully
exceeded 50% response rates.
This Phase 2 proof-of-concept trial is an open-label study to
assess the safety and efficacy of batoclimab in Graves’ disease.
Patients who are hyperthyroid despite treatment with an
anti-thyroid medication (ATD) for more than 12 weeks are being
enrolled to receive once-weekly subcutaneous (SC) injections of 680
mg batoclimab for 12 weeks followed by once-weekly SC injections of
340 mg batoclimab for 12 weeks. Treatment response is defined as
normalization of T3 and T4 hormone levels without increasing ATD
dose. The primary and secondary outcome measurements of the trial
are being measured at weeks 12 and 24. This design allowed for
efficacy assessments between two distinct ranges of IgG
reductions.
Consistent with studies of batoclimab in other indications, 680
mg administered SC in the initial cohort demonstrated potential
best-in class IgG reduction, up to 87%, with a mean IgG reduction
of 81% after 12 weeks of treatment. The 340 mg IgG reductions were
lower. A similar dose response was observed for
anti-TSHR autoantibodies, with deeper reductions observed following
treatment with 680 mg of SC batoclimab as compared to 340 mg of SC
batoclimab. In addition, across a range of clinical parameters,
numerically higher responses were observed following treatment with
680 mg of batoclimab as compared to treatment with 340 mg of
batoclimab. These parameters included the percentage of patients
whose ATD dose was reduced and the percentage of patients whose ATD
was discontinued. Batoclimab was generally well tolerated
with no new safety signals observed in the initial data
set.
“We believe the enrolled population is unlikely to spontaneously
remit and therefore a greater than 50% response rate is
encouraging,” said Pete Salzmann, M.D., chief executive officer at
Immunovant. “While preliminary, these data suggest there is a
dose response on efficacy between a regimen that produces 60-70%
IgG reductions, such as 340 mg of batoclimab, and a regimen that
produces 80% IgG reductions. We are excited to have what we believe
to be the only option across the anti-FcRn field of a simple SC
injection to produce this profile. We believe there is a high unmet
need in second line Graves’ disease and are enthusiastic about the
addressable market size here. While this trial is ongoing, we
intend to focus our future development in Graves’ on IMVT-1402,
with plans expected to be announced later in 2024.”
About Immunovant, Inc.Immunovant, Inc. is a
clinical-stage immunology company dedicated to enabling normal
lives for people with autoimmune diseases. As a trailblazer in
anti-FcRn technology, the Company is developing innovative,
targeted therapies to meet the complex and variable needs of people
with autoimmune diseases. For additional information on the
Company, please visit www.immunovant.com.
Forward-Looking StatementsThis press release
contains forward-looking statements for the 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 "can," “may,” “might,” “will,” “would,” “should,” “expect,”
“believe,” “estimate,” “design,” “plan,” "intend," and other
similar expressions are intended to identify forward-looking
statements. Such forward looking statements include Immunovant’s
expectations regarding the timing, design, and results of clinical
trials of its product candidates; Immunovant's plan to develop
batoclimab and IMVT-1402 across a broad range of autoimmune
indications; and potential benefits of batoclimab’s and IMVT-1402’s
unique product attributes and potential best-in-class profile
including IgG reduction. All forward-looking statements are based
on estimates and assumptions by Immunovant’s management that,
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 that Immunovant expected. Such risks and uncertainties
include, among others: initial results or other preliminary
analyses or results of early clinical trials may not be predictive
final trial results or of the results of later clinical trials; the
timing and availability of data from clinical trials; the timing of
discussions with regulatory agencies, as well as regulatory
submissions and potential approvals; the continued development of
Immunovant’s product candidates, including the timing of the
commencement of additional clinical trials; Immunovant’s scientific
approach, clinical trial design, indication selection, and general
development progress; future clinical trials may not confirm any
safety, potency, or other product characteristics described or
assumed in this press release; any product candidate that
Immunovant develops may not progress through clinical development
or receive required regulatory approvals within expected timelines
or at all; Immunovant’s product candidates may not be beneficial to
patients, or even if approved by regulatory authorities,
successfully commercialized; the potential impact of global
factors, such as the post-COVID-19 environment, geopolitical
tensions, and adverse macroeconomic conditions on Immunovant’s
business operations and supply chain, including its clinical
development plans and timelines; Immunovant’s business is heavily
dependent on the successful development, regulatory approval and
commercialization of batoclimab and IMVT-1402; Immunovant is at an
early stage of development for IMVT-1402 and in various stages of
clinical development for batoclimab; and Immunovant will require
additional capital to fund its operations and advance batoclimab
and IMVT-1402 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 titled “Risk Factors” in
Immunovant’s Form 10-Q filed with the SEC on November 9, 2023, 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.
Contact:Chau Cheng, PhD, MBAVice President,
Investor RelationsImmunovant, Inc.info@immunovant.com
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