Viridian Therapeutics Submits Investigational New Drug Application for VRDN-001, an IGF-1R antibody for the treatment of Thyroid Eye Disease, to the U.S. Food and Drug Administration
October 14 2021 - 8:00AM
Viridian Therapeutics, Inc. (NASDAQ: VRDN), a biopharmaceutical
company advancing new treatments for patients suffering from
serious diseases underserved by today's therapies, announced today
the submission of an investigational new drug (IND) application to
the United States Food and Drug Administration (FDA). The Company
is seeking authorization to initiate a Phase 1/2 clinical trial of
VRDN-001, an anti-insulin-like growth factor-1 receptor (IGF-1R)
monoclonal antibody in development for the treatment of thyroid eye
disease (TED), a debilitating disease that can cause proptosis
(bulging eyes), double vision, and potential blindness.
The Company believes this clinical trial could
provide key proof of concept clinical data in TED patients, with
the potential to show clinically meaningful improvements in signs
and symptoms of TED, including proptosis. The Company expects to
announce top line clinical data from the proof of concept portion
of the proposed trial in the second quarter of 2022.
“Our IND filing is an important milestone as we
continue to advance the development of VRDN-001 as a potential
treatment for patients suffering from Thyroid Eye Disease. We look
forward to launching this trial upon IND activation,” stated
Jonathan Violin, Ph.D., President and Chief Executive Officer of
Viridian. “Our IND submission features a trial protocol designed to
rapidly evaluate proof of concept, with flexibility to subsequently
assess different doses and treatment regimens that may
differentiate VRDN-001 from currently available therapies.”
About VRDN-001
VRDN-001, Viridian’s lead TED program, is an
intravenously administered anti-IGF-1R monoclonal antibody. This
antibody was previously in development as AVE1642 and was studied
in more than 100 oncology patients. The pharmacokinetic,
pharmacodynamic, safety, and tolerability data from the AVE1642
program inform Viridian’s development plans for VRDN-001.
About Viridian Therapeutics,
Inc.
Viridian Therapeutics is a biotechnology company
advancing new treatments for patients suffering from serious
diseases but underserved by today’s therapies. Viridian’s most
advanced program, VRDN-001, is a differentiated monoclonal antibody
targeting insulin-like growth factor-1 receptor (IGF-1R), a
clinically and commercially validated target for the treatment of
thyroid eye disease (TED). TED is a debilitating autoimmune disease
that causes inflammation and fibrosis within the orbit of the eye
which can cause double vision, pain, and potential blindness.
Patients with severe disease often require multiple remedial
surgeries to the orbit, eye muscles and eyelids. Viridian is based
in Waltham, Massachusetts.
Note Regarding Forward-Looking Statements
This press release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. These statements may be identified by the use
of words such as, but not limited to, "anticipate," "believe,"
"continue," "could," "estimate," "expect," "intend," "may,"
"might," "plan," "potential," "predict," "project," "should,"
"target," "will," or "would" or other similar terms or expressions
that concern our expectations, plans and intentions.
Forward-looking statements include, without limitation, statements
regarding the Company’s expectations regarding its clinical trial
plans for VRDN-001, the activation of the Company’s IND for
VRDN-001 by the FDA, the timing and nature of the initial results
from such trials, and the therapeutic potential of VRDN-001, as
compared to other therapies. Forward-looking statements are neither
historical facts nor assurances of future performance. Instead,
they are based on our current beliefs, expectations, and
assumptions. New risks and uncertainties may emerge from time to
time, and it is not possible to predict all risks and
uncertainties. No representations or warranties (expressed or
implied) are made about the accuracy of any such forward-looking
statements. Such forward-looking statements are subject to a number
of material risks and uncertainties including but not limited to:
the satisfaction of customary closing conditions related to the
proposed underwritten public offering; and other risks and
uncertainties identified in our filings with the SEC, including
those risks set forth under the caption “Risk Factors” in our
Quarterly Report on Form 10-Q filed with the Securities and
Exchange Commission (SEC) on August 12, 2021 and other subsequent
disclosure documents filed with the SEC. Any forward-looking
statement speaks only as of the date on which it was made. Neither
we, nor our affiliates, advisors, or representatives, undertake any
obligation to publicly update or revise any forward-looking
statement, whether as a result of new information, future events or
otherwise, except as required by law. These forward-looking
statements should not be relied upon as representing our views as
of any date subsequent to the date hereof.
Viridian Contacts:
Investors:Dan FerryLifeSci
Advisors617-430-7576IR@viridiantherapeutics.com
Media:Darby PearsonVerge Scientific
Communications703-587-0831PR@viridiantherapeutics.com
Source: Viridian Therapeutics, Inc.
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