Viridian Therapeutics, Inc. (NASDAQ: VRDN), a biotechnology company
advancing new treatments for patients suffering from serious
diseases underserved by current therapies, presented positive
proof-of-concept data from the 10 mg/kg cohort in its ongoing Phase
1/2 clinical trial of VRDN-001, an anti-IGF-1R antibody, in
patients with active thyroid eye disease (TED). These data, as well
as new in vitro data further characterizing and differentiating the
pharmacological profile of VRDN-001, were included as part of three
late-breaking poster presentations at the American Thyroid
Association (ATA) 91st Annual Meeting. The abstract describing new
in vitro data on the distinct anti-IGF-1R profile of VRDN-001 was
also selected as an oral highlighted late breaking presentation.
The three posters are available on the Viridian website (click
here).
“Patients suffering from TED would benefit from additional
therapeutic options,” said Raymond Douglas, M.D., Ph.D., director
of the Orbital and Thyroid Eye Disease Program, Cedars-Sinai
Medical Center and an investigator in the VRDN-001 trial. “The
rapid and near complete resolution of key signs and symptoms of TED
in the majority of patients at six weeks following two infusions of
10 mg/kg VRDN-001 in a cohort of patients with active TED suggests
VRDN-001, with further study, may provide an important new option
for TED patients.”
ATA Poster #535: VRDN-001, a Full Antagonist Antibody to
the Insulin-Like Growth Factor Receptor-1 (IGF-1R) for Thyroid Eye
Disease (TED): Phase 1/2 Proof of Concept in Patients with
TED
Poster #535 presents proof-of-concept data from the first cohort
of patients with active TED treated in the ongoing Phase 1/2
clinical trial. In this cohort, a total of 8 patients were
randomized to receive two infusions of 10 mg/kg dose of VRDN-001 or
placebo intravenously; 6 patients received VRDN-001 and 2 patients
received placebo. In patients receiving VRDN-001, proptosis
response was achieved by 83% of patients, with a mean reduction of
2.4 mm from baseline. Clinical Activity Score (CAS) of 0 or 1 was
achieved by 83% of patients, with a mean reduction of 4.3 points
from baseline. Complete resolution of diplopia was achieved by 75%
of patients who presented with diplopia at baseline. VRDN-001
demonstrated a favorable safety and tolerability profile with no
reported SAEs, no hyperglycemia, and no infusion reactions.
Poster #535 was authored by Shoaib Ugradar, UCLA Stein Eye
Institute, Barrett Katz, Viridian Therapeutics, Denis
O’Shaughnessy, Viridian Therapeutics, Rochelle Summerfelt, Viridian
Therapeutics, Angela She, Viridian Therapeutics, and Raymond
Douglas, Cedars Sinai Medical Center.
ATA Poster #568: VRDN-001, A Potent and Selective
Insulin-Like Growth Factor-1 Receptor (IGF-1R) Antagonist Antibody
for Thyroid Eye Disease (TED): Phase 1 Safety and Pharmacodynamic
Results in Healthy Volunteers
Poster #568 presents full safety and pharmacodynamic data from
the completed healthy volunteer portion of the ongoing Phase 1/2
trial of VRDN-001. A total of 13 subjects were randomized to
receive two infusions of either 3, 10, or 20 mg/kg dose of VRDN-001
or placebo. Twelve subjects completed the trial; one of the
subjects in the 20 mg/kg group withdrew for personal reasons after
the first infusion and was followed through Day 35.
Plasma levels of IGF-1, a biomarker for IGF-1R antagonism,
increased five- to seven-fold above baseline indicating maximal
target engagement at all doses. All doses studied were generally
safe and well tolerated, with no cases of hearing impairment or
treatment related hyperglycemia and no infusion reactions.
Poster #568 was authored by Angela She, Barrett Katz, Rochelle
Summerfelt, Denis O’Shaughnessy, Brent Dickinson, Kelly Foster, and
Vahe Bedian of Viridian Therapeutics
ATA Poster #132: VRDN-001, a Full Antagonist Antibody to
the Insulin-Like Growth Factor-1 Receptor (IGF-1R) in Development
for Thyroid Eye Disease (TED), Binds to a Distinct Epitope from
Teprotumumab
Poster #132 presents preclinical data from in vitro studies of
VRDN-001.The data show that VRDN-001 binds the same region of the
IGF-1R as teprotumumab but engages a distinct epitope. This
difference in binding translated to differences in functional
effects: unlike the anti-IGF-1R antibody teprotumumab, which
incompletely antagonized IGF-1R function, VRDN-001 fully
antagonized ligand binding, receptor autophosphorylation, and
downstream signaling.
These pharmacological differences may provide a mechanistic
basis for the initial data reported from the ongoing VRDN-001 Phase
1/2 study, including the pharmacodynamic responses in the healthy
volunteer cohort presented in Poster #568 and favorable clinical
responses seen in TED patients as presented in Poster #535.
Poster #132 was authored by Yang Zhao, Jordan Tsai, Rachel
Newell, and Vahe Bedian of Viridian Therapeutics.
Upcoming Clinical Milestones for the Ongoing VRDN-001
Phase 1/2 Proof-of-Concept Trial
The Company remains on track to present additional updates from
the VRDN-001 Phase 1/2 study this quarter. These updates will
include top-line data for the 20 mg/kg cohort of the ongoing Phase
1/2 trial of VRDN-001 in TED, followed later this quarter by
top-line data from the currently enrolling 3 mg/kg cohort.
This ongoing trial is evaluating two infusions of VRDN-001,
three weeks apart, with efficacy measured six weeks after the first
dose. Each dose is evaluated in a cohort of eight patients,
randomized so that six patients receive VRDN-001 and two patients
receive placebo. The first cohort evaluated a dose of 10 mg/kg,
with initial clinical data reported on August 15, 2022.
The Company expects to initiate the pivotal program for
VRDN-001 by the end of 2022.
This quarter the Company also will report final pharmacokinetic
and pharmacodynamic data from Viridian’s first-in-human trial of
VRDN-002, a half-life extended IGF-1R antibody, which build upon
the recently presented interim results. The Company expects data
from a proof-of-concept trial of subcutaneously administered
VRDN-002 in the second half of 2023.
About Viridian Therapeutics, Inc.
Viridian Therapeutics is a biotechnology company advancing new
treatments for patients suffering from serious diseases underserved
by current therapies. Viridian’s most advanced program, 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).
VRDN-002 is a distinct anti-IGF-1R antibody and incorporates
half-life extension technology. VRDN-003 is an extended half-life
version of VRDN-001. Both VRDN-002 and VRDN-003 are designed for
administration as convenient, low-volume, subcutaneous injections.
TED is a debilitating autoimmune disease that causes inflammation
and fibrosis within the orbit of the eye which can cause double
vision, pain, and potential blindness. Viridian is based in
Waltham, Massachusetts.
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 and VRDN-002 or the treatment of TED; the
timing, progress and plans for the Company’s ongoing and future
research and clinical development programs; expectations regarding
the timing for data, including the expected timing of additional
data from the ongoing Phase 1/2 clinical trial of VRDN-001 and the
first-in-human Phase 1 clinical trial of VRDN-002, 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.
Investor & Media Contact:John
JordanViridian TherapeuticsVice President, Investor Relations and
Corporate Communications617-272-4691IR@viridiantherapeutics.com
Viridian Therapeutics (NASDAQ:VRDN)
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Viridian Therapeutics (NASDAQ:VRDN)
過去 株価チャート
から 7 2023 まで 7 2024