Viridian Therapeutics Announces FDA Clearance of Investigational New Drug Application to Initiate Clinical Development of VRDN-002, a Next Generation IGF-1R Antibody for the Treatment of Thyroid Eye Disease
January 31 2022 - 7:00AM
Viridian Therapeutics, Inc. (NASDAQ: VRDN), a biotechnology company
advancing new treatments for patients suffering from serious
diseases underserved by current therapies, today announced the
United States Food and Drug Administration (FDA) clearance of its
investigational new drug (IND) application of VRDN-002. The
Company’s next generation IGF-1R antibody, VRDN-002, is a humanized
monoclonal antibody that incorporates half-life extension
technology and is designed to support administration as a
convenient, low-volume, subcutaneous (SC) injection for the
treatment of thyroid eye disease (TED).
The IND application clearance allows the Company to proceed with
its planned first-in-human Phase 1 clinical trial of VRDN-002,
which is a single ascending dose study to explore safety,
tolerability, pharmacokinetics and pharmacodynamics of
intravenously administered VRDN-002 in healthy volunteers. Data
from this Phase 1 trial are expected to be announced in mid-2022
and will inform the feasibility of a low-volume and/or
low-frequency SC dosing paradigm for TED patients.
“We are excited to advance our VRDN-002 clinical development
plan. We believe the incorporation of half-life extension
technology into VRDN-002 may enable a differentiated, low volume
subcutaneous injection, offering TED patients improved convenience
and broader settings of care,” stated Jonathan Violin, Ph.D.,
Viridian Therapeutics’ President and CEO. “This IND acceptance is
the first of multiple regulatory, clinical, and operational
milestones expected in 2022, including top-line data from our
VRDN-001 Phase 1/2 proof of concept trial in the second quarter of
2022, and top-line data from our VRDN-002 Phase 1 trial in
mid-2022.”
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). Viridian’s second product candidate, VRDN-002, is a
distinct anti-IGF-1R antibody that incorporates half-life extension
technology and is designed to support administration as a
convenient, low-volume, subcutaneous injection. 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 and VRDN-002, the timing and nature of the initial results
from such trials, and the therapeutic potential of VRDN-001 and
VRDN-002, 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.
Investor and Media Contact:John JordanViridian
TherapeuticsVice President, Investor Relations& Corporate
Communications617-272-4691IR@viridiantherapeutics.com
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