Eledon Provides Enrollment Update for Phase 2 BESTOW Trial Assessing Tegoprubart for the Prevention of Organ Rejection
29 Luglio 2024 - 1:00PM
Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today
announced that it has enrolled the 80th participant in its ongoing
Phase 2 BESTOW trial assessing tegoprubart for the prevention of
rejection in kidney transplantation.
“As of this week, we have already enrolled two-thirds of the
projected study participants across sites in the United States,
Europe and Latin America,” said David-Alexandre C. Gros, M.D.,
Chief Executive Officer of Eledon. “We are grateful to the
participants and their clinical teams, whose high level of interest
enabled us to achieve this level of enrollment in our Phase 2
BESTOW trial. This progress underscores the urgency and need for
innovative solutions in preventing kidney transplant rejection. We
remain on track to complete enrollment by the end of the year.”
BESTOW, a multicenter, two-arm, active comparator clinical
study, will enroll approximately 120 participants undergoing kidney
transplantation in the United States, Europe and Latin America to
evaluate the safety, pharmacokinetics, and efficacy of the
anti-CD40 ligand antibody tegoprubart compared to the calcineurin
inhibitor tacrolimus. The study’s primary objective is to assess
graft function at 12 months post-transplant, as measured by
estimated glomerular filtration rate (eGFR), in participants
treated with tegoprubart compared to tacrolimus. Better graft
function as assessed by eGFR has been associated with improved
long-term patient and graft survival.
Eledon is currently conducting a Phase 2 trial (BESTOW;
NCT05983770), a Phase 1b trial (NCT05027906), and a long-term
safety and efficacy extension study (NCT06126380) to evaluate
tegoprubart for the prevention of organ rejection in patients
receiving a kidney transplant.
About Eledon Pharmaceuticals and
tegoprubart
Eledon Pharmaceuticals, Inc. is a clinical stage
biotechnology company that is developing immune-modulating
therapies for the management and treatment of life-threatening
conditions. The Company’s lead investigational product is
tegoprubart, an anti-CD40L antibody with high affinity for the CD40
Ligand, a well-validated biological target that has broad
therapeutic potential. The central role of CD40L signaling
in both adaptive and innate immune cell activation and
function positions it as an attractive target for
non-lymphocyte depleting, immunomodulatory therapeutic
intervention. The Company is building upon a deep historical
knowledge of anti-CD40 Ligand biology to conduct preclinical and
clinical studies in kidney allograft transplantation,
xenotransplantation, and amyotrophic lateral sclerosis (ALS).
Eledon is headquartered in Irvine, California. For
more information, please visit the Company’s website
at www.eledon.com.
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Forward-Looking Statements
This press release contains forward-looking statements that
involve substantial risks and uncertainties. Any statements about
the company’s future expectations, plans and prospects, including
statements about planned clinical trials, the development of
product candidates, expected timing for initiation of future
clinical trials, expected timing for receipt of data from clinical
trials, expected or future results of tegoprubart trials and its
ability to prevent rejection in connection with kidney
transplantation, as well as 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. Forward-looking statements are inherently
uncertain and are subject to numerous risks and uncertainties,
including: risks relating to the safety and efficacy of our drug
candidates; risks relating to clinical development timelines,
including interactions with regulators and clinical sites, as well
as patient enrollment; and risks relating to costs of clinical
trials and the sufficiency of the company’s capital resources to
fund planned clinical trials. 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 U.S. Securities and Exchange
Commission, 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.
Investor Contact:
Stephen JasperGilmartin Group(858) 525
2047stephen@gilmartinir.com
Media Contact:
Jenna UrbanBerry & Company Public Relations(212) 253
8881jurban@berrypr.com
Source: Eledon Pharmaceuticals
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