- THRIVE-2 exceeded its enrollment target due
to patient demand; 188 patients enrolled with approximately 40%
from US sites -
- THRIVE topline readout in patients with
active TED on track for September 2024 -
- THRIVE-2 topline readout on track for
year-end 2024 -
Viridian Therapeutics, Inc. (NASDAQ: VRDN), a biotechnology
company focused on discovering and developing potential
best-in-class medicines for serious and rare diseases, today
announced that enrollment is complete in THRIVE-2, its phase 3
clinical trial for VRDN-001 in patients with chronic TED.
THRIVE-2 enrolled 188 patients globally and exceeded the
enrollment target of 159 patients due to patient demand.
Approximately 40% of the enrolled patients were from US sites.
Topline data from THRIVE-2 is on track for readout by year-end
2024. Previously, Viridian announced that THRIVE, its phase 3
clinical trial for VRDN-001 in patients with active TED, completed
and exceeded enrollment in March 2024 with approximately 50% of
patients enrolled from US sites. Topline data for THRIVE is on
track for readout in September 2024.
“We are very pleased with our overall clinical trial enrollment
for the VRDN-001 trials,” said Steve Mahoney, Viridian’s President
and Chief Executive Officer. “THRIVE and THRIVE-2 have now each
exceeded their enrollment targets and enrolled substantial patient
numbers in the US due to patient demand. We look forward to our
topline data readout for THRIVE in September and for THRIVE-2 at
the end of this year. We are also on track to initiate two
subcutaneous VRDN-003 phase 3 clinical trials, REVEAL-1 and
REVEAL-2, in August as planned.”
About VRDN-001
Viridian’s lead product candidate, VRDN-001, is an intravenously
(IV) delivered monoclonal antibody that acts as a full antagonist
of the insulin-like growth factor-1 receptor (IGF-1R). IGF-1R is a
clinically and commercially validated target for thyroid eye
disease (TED) that had US revenues of approximately $1.8 billion in
2023. VRDN-001 has the potential to improve patient experience with
a differentiated dosing regimen that features a shorter infusion
time and fewer infusions compared to the currently approved and
marketed IGF-1R inhibitor.
Viridian is evaluating VRDN-001 in two global phase 3 clinical
trials, THRIVE and THRIVE-2, for the treatment of active and
chronic TED, respectively. THRIVE and THRIVE-2 are each designed to
compare a five-dose treatment arm of VRDN-001 to placebo, each
dosed three weeks apart. In phase 2 clinical trials in active and
chronic TED, VRDN-001 was shown to improve the signs and symptoms
of TED at six weeks after two infusions in all dose cohorts and was
generally well-tolerated.
Viridian believes that the differentiated VRDN-001 has the
potential to establish a strong foothold in the
multi-billion-dollar TED commercial market, if approved, and will
help facilitate the introduction of VRDN-003, its potential
best-in-class subcutaneous IGF-1R antibody for TED.
About Viridian Therapeutics
Viridian 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 protein engineering enables the development of
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
is conducting a pivotal program for VRDN-001, including two global
phase 3 clinical trials (THRIVE and THRIVE-2), to evaluate its
efficacy and safety in patients with active and chronic TED.
Viridian is also advancing VRDN-003 as a potential best-in-class
subcutaneous therapy for the treatment of TED, including two
planned global phase 3 clinical trials, REVEAL-1 and REVEAL-2, to
evaluate the efficacy and safety of VRDN-003 in patients with
active and chronic TED.
In addition to its TED portfolio, Viridian is advancing a novel
portfolio of neonatal Fc receptor (FcRn) inhibitors, including
VRDN-006 and VRDN-008, which has the potential to be developed in
multiple autoimmune diseases.
Viridian is based in Waltham, Massachusetts. For more
information, please visit www.viridiantherapeutics.com. Follow
Viridian on LinkedIn and X.
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 are
neither historical facts nor assurances of future performance.
Instead, they are based on our current beliefs, expectations, and
assumptions. Forward-looking statements include, without
limitation, statements regarding: clinical programs and clinical
development of Viridian’s product candidates; anticipated start
dates and designs of studies, including the REVEAL-1 and REVEAL-2
clinical trials; upcoming milestones and anticipated data readouts
and results and timing of these readouts, including topline
readouts and results; that VRDN-001 has the potential to improve
patient experience with a differentiated dosing regimen that
features a shorter infusion time and fewer infusions compared to
the currently approved and marketed IGF-1R inhibitor; that that the
differentiated VRDN-001 has the potential to establish a strong
foothold in the multi-billion dollar TED commercial market, if
approved, and will help facilitate the introduction of VRDN-003,
its potential best-in-class subcutaneous IGF-1R antibody, for TED;
anticipated dosing frequency; the potential utility, efficacy,
potency, safety, clinical benefits, clinical response and
convenience of VRDN-001, VRDN-003, VRDN-006 and VRDN-008; the
potential for the portfolio of neonatal Fc receptor (FcRn)
inhibitors to be developed in multiple autoimmune diseases; and
Viridian’s product candidates potentially being best-in-class.
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: potential
utility, efficacy, potency, safety, clinical benefits, clinical
response and convenience of Viridian’s product candidates; the
relationship between the results from the positive data from
completed or ongoing clinical trials and the results of ongoing or
future clinical trials; that preliminary data may not be
representative of final data; the timing, progress and plans for
our ongoing or future research, preclinical and clinical
development programs; trial protocols for ongoing clinical trials;
expectations regarding the timing for regulatory filings;
regulatory interactions; expectations regarding the timing for
enrollment and data; uncertainty and potential delays related to
clinical drug development; the duration and impact of regulatory
delays in our clinical programs; the timing of and our ability to
obtain and maintain regulatory approvals for our therapeutic
candidates; manufacturing risks; competition from other therapies
or products; estimates of market size; Viridian’s intellectual
property position; the timing of preclinical and clinical trial
activities and reporting results from same; and those risks set
forth under the caption “Risk Factors” in our most recent quarterly
report on Form 10-Q filed with the Securities and Exchange
Commission (SEC) on May 8, 2024 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 the company, nor
its 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 the company’s
views as of any date subsequent to the date hereof.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240725241981/en/
Louisa Stone, 617-272-4604 Manager, Investor Relations
IR@viridiantherapeutics.com
Viridian Therapeutics (NASDAQ:VRDN)
Historical Stock Chart
From Sep 2024 to Oct 2024
Viridian Therapeutics (NASDAQ:VRDN)
Historical Stock Chart
From Oct 2023 to Oct 2024