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 multiple abstracts featuring updates on the
Company’s investigational therapies for the treatment of thyroid
eye disease (TED)—including new preclinical research on
VRDN-003—will be presented at the Annual Meeting of the Association
for Research in Vision and Ophthalmology (ARVO 2023), to be held
April 23-27, 2023, in New Orleans, Louisiana.
A platform session will feature the proof-of-concept results
from the Phase 1/2 trial of VRDN-001 in patients with TED, while
two posters will present new preclinical pharmacokinetic and
bioavailability data on VRDN-002 as well as pharmacokinetic,
pharmacodynamic, and safety data from healthy volunteers treated
with VRDN-002. Two additional poster presentations will highlight
the design, characterization, and preclinical pharmacokinetics of
VRDN-003. VRDN-002 and VRDN-003 are next-generation, half-life
extended antibody antagonists to the insulin-like growth factor-1
receptor (IGF-1R), in development for TED.
Oral Presentation
Data from Viridian’s ongoing Phase 1/2 clinical trial of
VRDN-001 will be highlighted in an oral presentation on Thursday,
April 27, 2023, from 2:15 to 2:30 pm CDT, during a session entitled
“Eye Movement Disorders.”
Poster Presentations
Title: |
RDN-002, a Next-Generation Half-life Extended Antagonist
Antibody to IGF-1 Receptor for Thyroid Eye
Disease: Safety and Pharmacokinetic/Pharmacodynamic (PK/PD) Results
in Healthy Volunteers |
Session: |
Thyroid eye disease and
extraocular muscles |
Information: |
Wednesday, April 26, 2023, 10:30
am to 12:15 pm CDT, Poster #4038 - B0355 |
Title: |
Preclinical Pharmacokinetics and Bioavailability of
VRDN-002, a Next-Generation Half-Life Extended Antagonist Antibody
to IGF-1 Receptor for Thyroid Eye Disease |
Session: |
Thyroid eye disease and
extraocular muscles |
Information: |
Wednesday, April 26, 2023, 10:30
am to 12:15 pm CDT, Poster #4039 - B0356 |
Title: |
Preclinical Pharmacokinetics of VRDN-003, A Next-Generation
Half-life Extended Antibody to the IGF-1 Receptor for Thyroid Eye
Disease |
Session: |
Thyroid eye disease and
extraocular muscles |
Information: |
Wednesday, April 26, 2023, 10:30
am to 12:15 pm CDT, Poster #4043 - B0360 |
Title: |
Design and Preclinical Characterization of VRDN-003, a
Next-Generation, Half-life Extended Antibody to IGF-1 Receptor in
Development for Thyroid Eye Disease |
Session: |
Thyroid eye disease and
extraocular muscles |
Information: |
Wednesday, April 26, 2023, 10:30
am to 12:15 pm CDT, Poster #4044 - B0361 |
|
|
Following their presentation at ARVO 2023, the above abstracts
will be posted
at www.viridiantherapeutics.com/pipeline/scientific-presentations.
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. Preliminary 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: treatment with VRDN-001 led to clinically
meaningful reductions in proptosis, improvement in clinical
activity score (CAS), and diplopia resolution. VRDN-001 had a
favorable safety profile and was well tolerated in the trial. The
Company is running a Phase 3 trial, known as THRIVE, in patients
with active TED.
VRDN-001 is also being evaluated in Phase 2 trial cohorts in
patients with chronic TED. Pending the release of that data, the
Company plans to initiate its THRIVE-2 Phase 3 trial in patients
with chronic TED.
The Company is advancing VRDN-001, VRDN-002, and VRDN-003 as
subcutaneous (SC) program candidates. All three candidates have the
potential to be developed for self-administration by a convenient,
SC pen device. VRDN-001 IV’s low-dose data support its potential as
a SC candidate. VRDN-002 is a novel anti-IGF-1R monoclonal antibody
incorporating half-life extension technology. VRDN-003 is an
anti-IGF-1R monoclonal antibody with the same amino acid sequence
as VRDN-001, except for the addition of the half-life extension
technology that is incorporated in VRDN-002.
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 program for intravenously administered VRDN-001, the Company is
advancing three candidates for its subcutaneous strategy with the
goal of providing a more conveniently administered therapy to
patients with TED. Viridian is also developing multiple preclinical
assets in autoimmune and rare diseases.
Viridian is based in Waltham, Massachusetts. For more
information, please visit 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 the
Company’s expectations, plans and intentions. Forward-looking
statements include, without limitation, statements regarding the
Company’s expectations, strategies, plans and intentions.
Forward-looking statements are neither historical facts nor
assurances of future performance. Instead, they are based on the
Company’s 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: the potential efficacy
and safety of VRDN-001, VRDN-002 and VRDN-003 for the treatment of
TED, the timing progress and plans for the Company’s ongoing and
future research and clinical development plans, trial protocols for
ongoing or future clinical trials, including the clinical trials
for VRDN-001, VRDN-002 and VRDN-003, including those risks set
forth under the caption “Risk Factors” in the Company’s 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 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.
Contacts
Investors:Louisa Stone, 508-808-2400Manager, Investor
RelationsIR@viridiantherapeutics.com
Todd James, 617-272-4691Senior Vice President, Corporate Affairs
and Investor RelationsIR@viridiantherapeutics.com
Media:Matt Fearer, 617-272-4605Vice President, Corporate
CommunicationsMedia@viridiantherapeutics.com
Source: Viridian Therapeutics, Inc.
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