- On track to initiate two phase 3 clinical
trials of VRDN-003 in August 2024 -
- REVEAL-1 and REVEAL-2, will evaluate two
active dosing regimens of subcutaneously (SC) administered VRDN-003
in active and chronic thyroid eye disease (TED), with topline
readout anticipated in the first half of 2026 for both trials -
- VRDN-003 Biologics License Application (BLA)
submission anticipated by year-end 2026 -
- VRDN-003 is the only half-life extended
anti-IGF-1R antibody in clinical development with the potential for
convenient SC dosing as infrequently as every 8 weeks, for a total
of 3 administrations -
Viridian Therapeutics, Inc. (NASDAQ: VRDN), a biotechnology
company focused on discovering and developing potential
best-in-class medicines for serious and rare diseases, today
reported details of its plans to initiate a phase 3 clinical trial
program for its SC VRDN-003 product candidate for patients with
moderate-to-severe TED.
“We are very pleased to have completed a positive Type C meeting
with the FDA and to take this next step towards rapidly bringing a
highly differentiated treatment option to patients living with
TED,” said Steve Mahoney, Viridian’s President and Chief Executive
Officer. “We view VRDN-003 as a potentially best-in-class
anti-IGF-1R product candidate that is designed to preserve the
compelling IGF-1R clinical response we have seen in our earlier
proof-of-concept studies of VRDN-001. We believe this product
profile could maximize convenience as a low-volume, infrequent
subcutaneous injection and provide better access to treatment for
patients.”
Phase 3 Clinical Trials in Active and Chronic TED
Viridian is planning to initiate two randomized, double-masked,
placebo-controlled phase 3 clinical trials designed to evaluate the
efficacy and safety of subcutaneously administered VRDN-003 in
patients with active and chronic TED, named REVEAL-1 and REVEAL-2,
respectively. These clinical trials are expected to initiate in
August 2024.
In REVEAL-1, approximately 84 patients will be randomized in a
1:1:1 ratio to receive VRDN-003 SC or placebo every 4 weeks or
every 8 weeks. Patients will receive an initial 600mg loading dose
given as two 300mg injections, followed by single injections of
300mg thereafter for a total of 6 administrations in the 4-week
dosing regimen and a total of 3 administrations in the 8-week
regimen. In REVEAL-2, approximately 126 patients will be randomized
in the same manner for the same dosing regimens. The primary
endpoint in each clinical trial will be proptosis responder rate,
based on the achievement of at least 2mm improvement in proptosis
from baseline at week 24, versus placebo. Subsequently, patients
will be followed for an additional 28 weeks. Additional outcome
measures in each trial will include changes from baseline in
proptosis, clinical activity score (CAS) and diplopia.
“The current standard of care in TED requires 8 intravenous
doses, representing a significant burden for patients,” said Tom
Ciulla, Viridian’s Chief Medical Officer. “Subcutaneous VRDN-003
could transform the treatment experience for patients with
TED.”
Viridian anticipates topline data for both clinical trials to be
available in the first half of 2026 and to file a BLA by the end of
2026. The company plans to launch VRDN-003 with a commercially
available autoinjector pen.
About VRDN-003
VRDN-003 is a potential best-in-class, subcutaneously
administered anti-IGF-1R antibody in development for TED. VRDN-003
has the same binding domain as VRDN-001, was engineered to have a
longer half-life, and acts as a full antagonist of IGF-1R. IGF-1R
inhibition is the only approved mechanism of action that has been
clinically and commercially validated for TED and has shown to be
highly effective in treating the disease.
Phase 1 results in healthy volunteers showed a VRDN-003
half-life of 40-50 days which is 4-5x the half-life of VRDN-001.
Further, pharmacokinetic modeling predicts that convenient dosing
regimens of VRDN-003 (e.g., a low volume subcutaneous injection
once every 4 or 8 weeks) could achieve exposure levels of VRDN-003
that are equivalent to those of VRDN-001 that produced clinically
meaningful results in TED patients in a phase 2, proof-of-concept
clinical trial.
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 and is planning to
initiate a global phase 3 program, REVEAL and REVEAL-2, to evaluate
the efficacy and safety of VRDN-003 in patients with active and
chronic TED, respectively.
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 or clinical
development of Viridian’s product candidates; anticipated start
dates and designs of studies, including the REVEAL-1 and REVEAL-2
clinical trials; regulatory interactions and anticipated regulatory
submissions, including the anticipated BLA filing for VRDN-003;
upcoming milestones and anticipated data results, including topline
results; plans to launch VRDN-003 with a commercially available
autoinjector pen; VRDN-003 preserving the compelling IGF-1R
clinical response and exposure levels seen in Viridian’s earlier
proof-of-concept studies of VRDN-001; enrollment in Viridian’s
clinical studies; 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; 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/20240611897132/en/
Louisa Stone, 617-272-4604 Manager, Investor Relations
IR@viridiantherapeutics.com
Viridian Therapeutics (NASDAQ:VRDN)
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Viridian Therapeutics (NASDAQ:VRDN)
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