Novus Therapeutics Announces First Patient Enrolled in Phase 2a Clinical Trial of Anti-CD40L Antibody AT-1501 in Amyotrophic ...
02 Novembro 2020 - 10:00AM
Business Wire
Novus Therapeutics, Inc. (“Novus”) (NASDAQ: NVUS), a clinical
stage biopharmaceutical company focused on developing
life-changing, targeted medicines for patients undergoing organ or
cellular transplantation, as well as those living with
immunological diseases, today announced that the first subject has
been enrolled in the Phase 2a clinical trial evaluating AT-1501,
the Company’s lead product candidate, in adults with amyotrophic
lateral sclerosis (ALS). AT-1501 blocks the activation of the CD40L
pathway, which has been shown to improve muscle function, slow
disease progression, and improve survival in a pre-clinical animal
model of ALS. AT-1501 previously received orphan drug designation
from the U.S. Food and Drug Administration for the treatment of
ALS.
“Novus is committed to providing people living with ALS and
their families with a therapeutic solution to treat this
progressive and devastating disease as expeditiously as possible,”
said Steven Perrin, Ph.D., President and Chief Scientific Officer
of Novus. “We look forward to the safety and biomarker insights
from this study and we anticipate top-line data from this important
trial in 2022.”
"There is strong evidence that the reduction of peripheral
neuroinflammation has the capacity to influence disease progression
in ALS,” said Dr. Merit Cudkowicz, Director of the Sean M. Healey
& AMG Center for ALS, and Chief of Neurology at Massachusetts
General Hospital, Boston. “I am excited to see the clinical
advancement of AT-1501, which targets a key signaling pathway in
the generation of pro-inflammatory responses."
The AT-1501 Phase 2a trial in ALS is a 12-week, open label, dose
escalating, safety and biomarker study. The endpoints of the study
are safety and tolerability, and changes in pro-inflammatory
biomarkers as well as neurofilament light chain. Exploratory
clinical endpoints will also be assessed.
"We are in urgent need of new therapies for people living with
ALS,” said Dr. Michael Rivner, Charbonnier Professor of Neurology
and Director of the ALS Clinic at Georgia Regents Medical Center,
Augusta. “AT-1501 and the CD40/CD40L pathway represent a highly
promising approach to treating this disease.”
Novus Therapeutics has completed a Phase 1a/1b single ascending
dose trial in healthy volunteers and adults living with ALS. In
that trial, AT-1501 was well tolerated at all doses tested and
demonstrated a good safety profile. AT-1501 also demonstrated
linear dose proportionality across the dose range and a half-life
of up to 26 days.
About AT-1501
AT-1501 is a humanized IgG1 anti-CD40L antibody with high
affinity for CD40L, a well-validated target with broad therapeutic
potential. The CD40/CD40L pathway plays a central role in
generating pro-inflammatory responses in autoimmune disease,
allograft transplant rejection, and neuroinflammation. In a Phase 1
safety study of healthy volunteers and adults with ALS, AT-1501 was
well tolerated at all doses tested.
The discovery and early development of AT-1501 for ALS received
support from The ALS Therapy Development Institute, Augie’s Quest,
The Muscular Dystrophy Association, The ALS Association, ALS One,
ALS Finding a Cure, and The ALS Ice Bucket Challenge.
About Novus Therapeutics
Novus Therapeutics, Inc. is a clinical stage biotechnology
company using its expertise in targeting the CD40L pathway to
develop potential treatments for people requiring an organ or
cell-based transplant, and for people with autoimmune and
neurodegenerative disease. Novus is headquartered in Irvine,
California. For more information, please visit the company’s
website at www.novustherapeutics.com.
Follow Novus Therapeutics on social media: @Novus_Thera and
LinkedIn.
Forward-Looking Statements
This press release contains forward-looking statements that
involves substantial risks and uncertainties. Any statements about
the company’s future expectations, plans and prospects, including
statements about its strategy, future operations, development of
its product candidates, and other statements containing the words
“believes,” “anticipates,” “plans,” “expects,” “estimates,”
“intends,” “predicts,” “projects,” “targets,” “looks forward,”
“could,” “may,” and similar expressions, constitute forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995, although not all forward-looking statements
include such identifying words. Forward-looking statements include,
but are not limited to statements regarding: risks related to
market conditions; expectations regarding the timing for the
commencement of future clinical trials; expectations regarding the
success of clinical trials; the rate and degree of market
acceptance and clinical utility of the company’s products; the
company’s estimates regarding expenses and cash runway; and the
impact of the ongoing coronavirus pandemic. Actual results may
differ materially from those indicated by such forward-looking
statements as a result of various factors. These risks and
uncertainties, as well as other risks and uncertainties that could
cause the company’s actual results to differ significantly from the
forward-looking statements contained herein, are discussed in our
quarterly 10-Q, annual 10-K, and other filings with the SEC, which
can be found at www.sec.gov. Any forward-looking statements
contained in this press release speak only as of the date hereof
and not of any future date, and the company expressly disclaims any
intent to update any forward-looking statements, whether as a
result of new information, future events or otherwise.
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Novus Therapeutics (NASDAQ:NVUS)
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