Viridian Therapeutics Announces FDA Clearance of Investigational New Drug (IND) Application for VRDN-001, an IGF-1R Antibody for the Treatment of Thyroid Eye Disease (TED)
November 15 2021 - 7:00AM
Viridian Therapeutics, Inc. (NASDAQ: VRDN) (the “Company” or
“Viridian”), a biotechnology company advancing new treatments for
patients suffering from serious diseases underserved by current
therapies, today announced the U.S. Food and Drug Administration
(“FDA”) clearance of its Investigational New Drug (“IND”)
application for VRDN-001, which the Company is developing for the
treatment of thyroid eye disease (TED).
VRDN-001 is a monoclonal antibody that binds and blocks the
IGF-1R signaling pathway with sub-nanomolar affinity. This
mechanism of action is clinically and commercially validated for
the treatment of TED. The Company’s first clinical trial for
VRDN-001 is a Phase 1/2 proof of concept trial including multiple
randomized, placebo-controlled cohorts of TED patients to assess
the potential for VRDN-001 to provide rapid improvement of signs
and symptoms of TED, including proptosis. The protocol for this
trial allows for additional patient cohorts to assess differing
treatment paradigms that may offer advantages over currently
available therapies and mitigate patient treatment burden. The
Company expects to announce top line data from the proof of concept
portion of the trial in the second quarter of 2022.
“Our first clinical trial for VRDN-001 is designed to rapidly
test proof of concept while enabling data-driven evaluation of
dosing paradigms that could offer TED patients new and
differentiated therapeutic options. With the IND accepted by the
FDA, we remain on track to report top line clinical data for
VRDN-001 in the second quarter of 2022,” stated Jonathan Violin,
Ph.D., Viridian’s President and CEO. “This is the first milestone
in what we expect to be a busy 12 months as we advance the
development of our clinical and preclinical pipeline of potential
best in class therapeutics.”
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 and guidance regarding its clinical trial plans for
VRDN-001, , 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: uncertainty and
potential delays related to clinical drug development; the duration
and impact of regulatory delays in our clinical programs;
manufacturing risks; competition from other therapies or products;
the timing of and clinical trial activities and reporting results
from same; the effects from the COVID-19 pandemic on the company’s
research, development and business activities and operating
results, 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 November 5, 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
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