- Oral presentation to describe distinct
receptor binding and mechanistic characteristics of VRDN-001,
Company’s lead pipeline candidate in its thyroid eye disease
program -
- Poster presentations to feature data from
ongoing Phase 1/2 trial of VRDN-001 -
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 data on the Company’s
lead investigational therapy for the treatment of thyroid eye
disease (TED) will be presented at the Annual Meeting of the
Endocrine Society (ENDO 2023) to be held June 15-18, 2023, in
Chicago, Illinois.
An oral presentation will highlight mechanistic features of
VRDN-001, a full antagonist antibody to the insulin-like growth
factor-1 receptor (IGF-1R), in development for TED, while poster
presentations will include clinical data from Viridian’s ongoing
Phase 1/2 trial of VRDN-001 as well as pharmacodynamic responses in
healthy volunteers and patients with active TED receiving
VRDN-001.
Oral Presentation
Title: VRDN-001, a Full Antagonist Antibody to IGF-1 Receptor
in Development for Thyroid Eye Disease (TED), Binds to a Distinct
Epitope from Teprotumumab Session: Thyroid Physiology—From the
lab to the patient Information: Saturday, June 17, 2023, 3:45 to
4:00 pm CDT, Session #OR26
Poster Presentations
Title: Durability of Treatment Response With VRDN-001, a Full
Antagonist Antibody to IGF-1 Receptor, in Patients with Thyroid Eye
Disease (TED): Phase 1/2 Clinical Study* Session: Thyroid
Biology & Cancer: Thyroid Autoimmunity Information: Friday,
June 16, 2023, 12:00 to 1:00 pm CDT, Poster #FRI-545
* During this session, this abstract will also be featured as a
Rapid Fire oral presentation #RF-11
Title: VRDN-001, a Full Antagonist Antibody to IGF-1 Receptor
in Development for Thyroid Eye Disease (TED): Pharmacodynamic
Responses in Healthy Volunteers and Patients with Active TED
Session: Thyroid Biology & Cancer: Thyroid Autoimmunity
Information: Friday, June 16, 2023, 12:00 to 1:00 pm CDT, Poster
#FRI-546
Clinical data in these presentations relate exclusively to
treatment of patients with active TED. The Company plans to provide
an update in June or July of this year on the treatment of patients
with chronic TED.
Following their presentation at ENDO 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
is conducting 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 and twitter.
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 9, 2023 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.
Source: Viridian Therapeutics, Inc.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230613522439/en/
Investors: Louisa Stone, 508-808-2400 Manager, Investor
Relations IR@viridiantherapeutics.com Todd James, 617-272-4691
Senior Vice President, Corporate Affairs and Investor Relations
IR@viridiantherapeutics.com Media: Matt Fearer, 617-272-4605 Vice
President, Corporate Communications
Media@viridiantherapeutics.com
Viridian Therapeutics (NASDAQ:VRDN)
Historical Stock Chart
Von Jun 2024 bis Jul 2024
Viridian Therapeutics (NASDAQ:VRDN)
Historical Stock Chart
Von Jul 2023 bis Jul 2024