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 on VRDN-001 and
VRDN-002—the Company’s investigational therapies for the treatment
of thyroid eye disease (TED)—will be presented at the 49th Annual
Meeting of the North American Neuro-Ophthalmology Society (NANOS),
to be held March 11 to 16, 2023, in Orlando, Florida.
An oral presentation with data from the ongoing Phase 1/2 trial
of VRDN-001, a full antagonist antibody to the insulin-like growth
factor 1 receptor (IGF-1R), is scheduled for the morning of
Tuesday, March 14, with four posters from Viridian’s TED program to
be presented that evening.
“We are pleased to present this encouraging data from our TED
pipeline at this important annual gathering,” said Barrett Katz,
M.D., M.B.A., Chief Medical Officer of Viridian. “Taken together,
the clinical and mechanistic data we are sharing at NANOS
strengthen our confidence not only in VRDN-001 as we work to enroll
patients in our active THRIVE Phase 3 trial, but also in our
ability to develop follow-on assets with the potential for
subcutaneous self-administration to decrease treatment burdens on
patients and their families living with TED.”
Oral Presentation
Title: |
VRDN-001, a Full Antagonist Antibody to IGF-1 Receptor for
Thyroid Eye Disease (TED): Phase 1/2 Clinical Study in
Patients |
Session: |
Platform Session II |
Date: |
Tuesday, March 14, 2023 |
Time: |
7:30 a.m. to 7:45 a.m. EST |
Poster Presentations
Title: |
VRDN-001, a Full Antagonist Antibody to IGF-1 Receptor in
Development for Thyroid Eye Disease (TED): Interim Phase 1/2
Pharmacodynamic Results |
Session: |
Meet the Poster Author: Analytical Studies |
Poster: |
#298 |
Date & Time: |
Tuesday, March 14, 6:00 p.m. to 8:30 p.m. |
Title: |
THRIVE: A Phase 3 Trial of VRDN-001, a Full Antagonist
Antibody to IGF-1 Receptor for Thyroid Eye Disease
(TED) |
Session: |
Meet the Poster Author: Analytical Studies |
Poster: |
#296 |
Date & Time: |
Tuesday, March 14, 6:00 p.m. to 8:30 p.m. |
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: |
Meet the Poster Author: Analytical Studies |
Poster: |
#297 |
Date & Time: |
Tuesday, March 14, 6:00 p.m. to 8:30 p.m. |
Title: |
VRDN-002, a Next-Generation Novel Antagonist Antibody to
IGF-1 Receptor for Thyroid Eye Disease (TED): Results of a Phase 1
Trial |
Session: |
Meet the Poster Author: Analytical Studies |
Poster: |
#299 |
Date & Time: |
Tuesday, March 14, 6:00 p.m. to 8:30 p.m. |
Following their presentation, the above abstracts will be posted
atwww.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. 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 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 recently initiated its
THRIVE Phase 3 trial in patients with active TED to support a
global marketing registration.
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-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 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.
ContactsInvestors: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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