Immunovant, Inc. (Nasdaq: IMVT),
a clinical-stage immunology company dedicated to enabling
normal lives for people with autoimmune diseases, today announced
that subcutaneously administered doses of IMVT-1402 produced
dose-dependent reductions in IgG in initial data from a Phase 1
clinical trial in healthy adults, with no dose-related changes in
serum albumin or LDL-C, bolstering IMVT-1402 as a potential
best-in-class neonatal fragment crystallizable receptor (FcRn)
inhibitor.
“We are encouraged by the strong pharmacodynamic data observed
to date with IMVT-1402,” said Pete Salzmann, M.D., chief executive
officer of Immunovant. “These first-in-human results are consistent
with those observed in prior non-human primate studies, and we look
forward to sharing additional MAD data in November.”
This Phase 1 clinical trial is a randomized, double-blind,
placebo-controlled ascending dose study to assess the safety,
tolerability, pharmacokinetics, and pharmacodynamics of IMVT-1402
in healthy adults.
In the single-ascending dose (SAD) portion of the study,
subcutaneously administered IMVT-1402 demonstrated a consistent
reduction in IgG with potency that was similar to or greater than
that of batoclimab. The safety data were generally favorable, with
all adverse events (AEs) mild or moderate, and no significant
reduction from baseline in serum albumin or increase in LDL-C
observed at any timepoint measured (all p>0.05).
Immunovant is also pleased to announce that initial MAD study
results for the 300 mg cohort were released ahead of schedule
today. These data represent all the MAD data currently available.
Dosing for the 600 mg cohort has recently begun. After four weekly
300 mg SC doses of IMVT-1402, the mean total IgG reduction from
baseline in this MAD cohort was 63%, with no decrease in serum
albumin below baseline and no increase in LDL-C above baseline
observed. Treatment-emergent adverse events were observed to be
mild or moderate in severity. IMVT-1402 was delivered
subcutaneously in seconds to participants in this cohort as a
simple 2 mL injection at a concentration of 150 mg/mL.
Conference Call & Webcast:Immunovant will
host a conference call with accompanying slides and a simultaneous
webcast today, September 26, 2023 at 8:00 a.m. EDT to discuss the
initial single-ascending dose and multiple-ascending dose data. To
participate in the conference call, please register in advance
here. To access the live and archived webcast, please visit
Immunovant’s website at
https://www.immunovant.com/investors/news-events. The archived
webcast will be available for a limited time on the Company’s
website.
About IMVT-1402IMVT-1402 is designed to be a
potentially best-in-class anti-FcRn antibody for the treatment of
IgG-mediated autoimmune diseases. In the initial results of a Phase
1 clinical trial in healthy volunteers, IMVT-1402 demonstrated
favorable pharmacodynamic and safety data. These attributes,
combined with a convenient route of administration that may enable
patient self-administration, position IMVT-1402 well as a potential
treatment for a variety of autoimmune diseases associated with
patient unmet need.
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 and results of Immunovant’s
clinical trials of IMVT-1402; and the potential benefits of
IMVT-1402’s unique product attributes and its best-in-class
potential. 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; results of animal studies
may not be predictive of results in humans; 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 and resumption of
current 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 August 10, 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.
About Roivant Roivant (Nasdaq: ROIV) is a
commercial-stage biopharmaceutical company that aims to improve the
lives of patients by accelerating the development and
commercialization of medicines that matter. Today, Roivant’s
pipeline is concentrated in inflammation and immunology and
includes VTAMA®, a novel topical approved for the treatment of
psoriasis and in development for the treatment of atopic
dermatitis; batoclimab and IMVT-1402, fully human monoclonal
antibodies targeting the neonatal Fc receptor (“FcRn”) in
development across several IgG-mediated autoimmune indications; and
RVT-3101, an anti-TL1A antibody in development for ulcerative
colitis and Crohn’s disease, in addition to several other therapies
in various stages of clinical development. We advance our pipeline
by creating nimble subsidiaries or “Vants” to develop and
commercialize our medicines and technologies. Beyond therapeutics,
Roivant also incubates discovery-stage companies and health
technology startups complementary to its biopharmaceutical
business. For more information, visit www.roivant.com.
Roivant Forward-Looking Statements This press
release contains forward-looking statements. Statements in this
press release may include statements that are not historical facts
and are considered forward-looking within the meaning of Section
27A of the Securities Act of 1933, as amended (the “Securities
Act”), and Section 21E of the Securities Exchange Act of 1934, as
amended (the “Exchange Act”), which are usually identified by the
use of words such as “anticipate,” “believe,” “continue,” “could,”
“estimate,” “expect,” “intends,” “may,” “might,” “plan,”
“possible,” “potential,” “predict,” “project,” “should,” “would”
and variations of such words or similar expressions. The words may
identify forward-looking statements, but the absence of these words
does not mean that a statement is not forward-looking. We intend
these forward-looking statements to be covered by the safe harbor
provisions for forward-looking statements contained in Section 27A
of the Securities Act and Section 21E of the Exchange Act.
Our forward-looking statements include, but are not limited to,
statements regarding our or our management team’s expectations,
hopes, beliefs, intentions or strategies regarding the future, and
statements that are not historical facts, including statements
about the clinical and therapeutic potential of our products and
product candidates, the availability and success of topline results
from our ongoing clinical trials and any commercial potential of
our products and product candidates. In addition, any statements
that refer to projections, forecasts or other characterizations of
future events or circumstances, including any underlying
assumptions, are forward-looking statements.
Although we believe that our plans, intentions, expectations and
strategies as reflected in or suggested by those forward-looking
statements are reasonable, we can give no assurance that the plans,
intentions, expectations or strategies will be attained or
achieved. Furthermore, actual results may differ materially from
those described in the forward-looking statements and will be
affected by a number of risks, uncertainties and assumptions,
including, but not limited to, those risks set forth in the Risk
Factors section of our filings with the U.S. Securities and
Exchange Commission. Moreover, we operate in a very competitive and
rapidly changing environment in which new risks emerge from time to
time. These forward-looking statements are based upon the current
expectations and beliefs of our management as of the date of this
press release, and are subject to certain risks and uncertainties
that could cause actual results to differ materially from those
described in the forward-looking statements. Except as required by
applicable law, we assume no obligation to update publicly any
forward-looking statements, whether as a result of new information,
future events or otherwise.
Contacts:
InvestorsRoivant Investor Relationsir@roivant.com
MediaStephanie LeeRoivant Sciencesstephanie.lee@roivant.com
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