Eledon Announces Completion of Enrollment in Phase 2 BESTOW Clinical Trial Assessing Tegoprubart for Prevention of Organ Rejection in Kidney Transplant Patients
04 Settembre 2024 - 1:00PM
Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today
announced that it has successfully completed enrollment for its
Phase 2 BESTOW clinical trial, which is designed to assess the
safety and efficacy of its investigational immunosuppression
therapy tegoprubart for the prevention of organ rejection in
patients undergoing kidney transplantation. The trial reached its
target enrollment of 120 participants approximately four months
earlier than originally planned.
“We are very pleased to achieve this critical milestone ahead of
schedule in our BESTOW trial,” said David-Alexandre C. Gros, M.D.,
Chief Executive Officer of Eledon. “The accelerated pace of
enrollment reflects the strong interest among both clinicians and
patients in new innovative therapies that have the potential to
improve outcomes in kidney transplantation compared to current
standard of care immunosuppression regimens. We are proud to be
leading the effort to transform the prevention of organ rejection
and based on the early completion of enrollment, we now anticipate
reporting top-line results for the BESTOW trial in the fourth
quarter of 2025.”
BESTOW, a multicenter, two-arm, active comparator clinical
study, enrolled 120 participants undergoing kidney transplantation
at sites in North America, Europe and Latin America to evaluate the
safety, pharmacokinetics, and efficacy of tegoprubart, an anti-CD40
ligand antibody, 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. Research has shown that better graft
function as assessed by eGFR has been associated with improved
long-term graft survival following kidney transplantation.
“Completing enrollment in the Phase 2 BESTOW trial is a
significant achievement for our team and, more importantly, for the
transplant community,” said Steve Perrin, Ph.D., Chief Scientific
Officer and President of Eledon. “It is a testament to the strong
collaboration with our clinical sites and the enthusiasm within the
community for advances in immunosuppression therapy, an area of
research that has not seen major therapeutic innovation in decades.
We are deeply grateful to the patients, their families, and the
clinical teams for their continued support in advancing this
important study.”
The BESTOW trial builds upon results from Eledon’s ongoing Phase
1b trial presented at the American Transplant Congress (ATC) in
June 2024, and further demonstrates that tegoprubart has the
potential to provide kidney transplant recipients with a safe and
effective alternative to calcineurin inhibitors, which are often
associated with side effects such as hyperglycemia, new onset
diabetes, hypertension, or tremors. Eledon plans to continue
advancing its tegoprubart clinical program with the goal of
offering a new standard of care immunosuppression therapy for organ
transplant patients.
Eledon is currently conducting the Phase 2 BESTOW trial
(NCT05983770), the 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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