Viridian Therapeutics, Inc. (NASDAQ: VRDN), a
biopharmaceutical company focused on discovering and developing
potential best-in-class medicines for serious and rare diseases,
today announced that the first patient has been enrolled in its
THRIVE Phase 3 trial evaluating the efficacy and safety of the
investigational agent VRDN-001 in patients with active thyroid eye
disease (TED). The global THRIVE Phase 3 trial will be conducted in
approximately 50 centers across North America and Europe.
"We are pleased to enroll the first patient in the THRIVE trial,
which is designed to confirm the compelling early results we’ve
seen in TED patients," said Jonathan Violin, Ph.D., President and
Chief Executive Officer of Viridian Therapeutics. "The study is a
significant milestone for Viridian, and reinforces our commitment
to the TED community. It is an important and meaningful step in our
efforts to provide new and improved treatment options to patients
with TED."
The THRIVE Phase 3 trial is a double-blind, placebo-controlled,
randomized study enrolling approximately 120 patients with active
TED. The study participants will be randomized 1:1:1 across three
arms: VRDN-001 10 milligrams per kilogram administered once every
three weeks for eight cycles, an accelerated course of VRDN-001 10
milligrams per kilogram administered once every three weeks for
five cycles, and a placebo arm.
The primary efficacy endpoint for THRIVE is proptosis (eye
bulging) responder rate, defined as the proportion of patients who
achieve a reduction of proptosis of at least 2 millimeters compared
to baseline at week 24. Secondary endpoints include overall
response rate, change in proptosis as measured by exophthalmometer
and magnetic resonance imaging (MRI), change in clinical activity
score, and rate of diplopia resolution. Following week 24, trial
participants may roll over into an open-label extension study
followed by a longer-term registry study.
The Company is also planning a second global Phase 3 trial in
patients with chronic TED called THRIVE-2. The THRIVE and THRIVE-2
Phase 3 trials will support global health authority registration
for marketing approval in both active and chronic TED.
VRDN-001 is an investigational therapy not approved for any use
in any country.
About Viridian’s Thyroid Eye Disease Pipeline (VRDN-001,
-002, and -003)
Viridian’s lead product candidate, 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). In preclinical studies,
VRDN-001 was shown to be a full antagonist of IGF-1R, with more
complete receptor blockade than other anti-IGF-1R antibodies,
including the only currently approved TED therapy. Data from the
initial dose cohorts of the Phase 2 portion of the ongoing trial
established clinical proof-of-concept for VRDN-001 in patients with
active TED. Preliminary data from the ongoing trial showed
treatment with VRDN-001 led to reductions in proptosis, clinical
activity score (CAS), and diplopia resolution. VRDN-001 was
generally safe and well tolerated in the trial. The Company
recently initiated its THRIVE Phase 3 trial in patients with active
TED to support global marketing registration.
VRDN-001 is also being evaluated in Phase 2 trial cohorts in
patients with chronic TED. Pending positive results, the Company
plans to start its THRIVE-2 Phase 3 trial in patients with chronic
TED.
The Company is also advancing VRDN-002, a distinct anti-IGF-1R
antibody incorporating half-life extension technology, and
VRDN-003, a half-life extended version of VRDN-001. Both VRDN-002
and VRDN-003 are designed for administration as convenient,
low-volume, subcutaneous injections.
VRDN-001, -002, and -003 are investigational therapies that are
not approved for any use in any country.
About TED
TED is a serious and debilitating rare autoimmune disease that
causes inflammation within the orbit of the eye that can cause
double vision, pain, and potential blindness. TED is a progressive
disease consisting of an initial active phase, followed by a
transition to a secondary chronic phase. More than 50,000 and
200,000 people are estimated to suffer from active and chronic TED,
respectively, in the United States and Europe.
About Viridian Therapeutics
Viridian Therapeutics is a biopharmaceutical company focused on
engineering and developing potential best-in-class medicines for
patients with serious and rare diseases. Viridian’s expertise in
antibody discovery and engineering enables it to develop
differentiated therapeutic candidates for previously validated drug
targets in commercially established disease areas.
Viridian is advancing multiple candidates in the clinic for the
treatment of patients with thyroid eye disease (TED). The Company
recently initiated its first global Phase 3 trial called ‘THRIVE’
to evaluate the safety and efficacy of VRDN-001 in patients with
active TED. Viridian is also evaluating VRDN-001 in a Phase 2
proof-of-concept trial in patients with chronic TED. In addition to
its intravenously administered VRDN-001 program, the Company is
advancing two candidates for its subcutaneous strategy with the
goal of providing a more conveniently administered therapy to
patients with TED. Viridian is developing multiple preclinical
assets in autoimmune and rare diseases.
Viridian is based in Waltham, Massachusetts. For more
information, please visit https://www.viridiantherapeutics.com.
Follow Viridian on LinkedIn.
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 global Phase 3 clinical
trial plans for VRDN-001, the timing and nature of the initial
results from its global Phase 3 THRIVE trial 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;
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:Todd JamesViridian
Therapeutics, Inc.Senior Vice President, Corporate Affairs and
Investor RelationsIR@viridiantherapeutics.com
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