Viridian Therapeutics Doses First Subject in First-in-Human Clinical Trial Evaluating VRDN-002, a Next Generation IGF-1R Antibody for the Treatment of Thyroid Eye Disease
21 März 2022 - 9:05PM
Viridian Therapeutics, Inc. (NASDAQ: VRDN), a biotechnology company
advancing new treatments for patients suffering from serious
diseases underserved by current therapies, today announced that it
has dosed the first subject in a Phase 1 clinical trial evaluating
VRDN-002 for the treatment of thyroid eye disease (TED).
This is a first-in-human Phase 1 clinical trial of VRDN-002, 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 TED patients. The single ascending dose trial
will explore safety, tolerability, pharmacokinetics and
pharmacodynamics of intravenously administered VRDN-002 at doses of
3, 10, and 20 mg/kg in up to 16 healthy volunteers. Topline data
from the trial are expected to be announced mid-year and will
inform the feasibility of a low-volume SC dosing paradigm for TED
patients.
“With VRDN-001 and VRDN-002, we are focused on developing a
portfolio approach to advance patient care for TED patients. The
initiation of this first-in-human trial of VRDN-002 delivers a key
milestone as we execute our development strategy for VRDN-002 and
ramp up clinical activity across our pipeline,” stated Jonathan
Violin, Ph.D., Viridian Therapeutics’ President and CEO.
“Incorporating half-life extension technology that may enable SC
administration is a significant step forward in the treatment of
TED. The option of a SC injection would broaden the settings of
care, either at home by patients via self-administration or in the
prescribing physician’s office.”
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 humanized 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-002, the timing and nature of the initial results from such
trial 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; other matters that could affect the
sufficiency of existing cash, cash equivalents and short-term
investments to fund operations; the Company’s future operating
results and financial performance; the timing of pre-clinical 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 Annual Report on Form 10-K filed with the Securities and
Exchange Commission (SEC) on March 11, 2022 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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