Immunovant Announces Positive Initial IMVT-1402 Phase 1 SAD and 300 mg Subcutaneous MAD Results
26 September 2023 - 12:00PM
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 of 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.
Contact:Chau Cheng, PhD, MBAVice President,
Investor RelationsImmunovant, Inc.info@immunovant.com
Immunovant (NASDAQ:IMVT)
Historical Stock Chart
Von Apr 2024 bis Mai 2024
Immunovant (NASDAQ:IMVT)
Historical Stock Chart
Von Mai 2023 bis Mai 2024