Eledon Pharmaceuticals Announces First Participant Dosed in Phase 2 BESTOW Trial Evaluating Tegoprubart for the Prevention of Rejection in Kidney Transplantation
05 Septembre 2023 - 1:00PM
Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today
announced the first participant has been dosed in the Company’s
Phase 2 BESTOW trial evaluating tegoprubart for the prevention of
organ rejection in patients receiving a kidney transplant.
BESTOW, a multicenter, two-arm, active comparator
clinical study, will enroll approximately 120 participants
undergoing kidney transplantation in the United States and other
countries 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.
Secondary objectives will include graft survival, biopsy-proven
acute rejection, and the incidence of new onset diabetes mellitus
after transplant. Eledon will also be using the iBox Scoring
System, a composite endpoint of kidney graft function using
clinical, histological, and serum biomarkers for the early
prediction of graft failure, as an exploratory endpoint.
“We are excited to initiate enrollment in the Phase 2 BESTOW
clinical trial, a critical next step in our evaluation of
tegoprubart as a potential new immunosuppressive regimen to prevent
rejection and improve graft function in patients receiving kidney
transplants,” said David-Alexandre C. Gros, M.D., Eledon’s Chief
Executive Officer. “This study aims to build on the growing body of
evidence, including recently reported results from our Phase 1b
trial, reinforcing our belief in the potential of tegoprubart to
replace calcineurin inhibitors and provide kidney transplant
recipients a much-needed alternative associated with better kidney
function, reduced side effects and longer lifespans for
transplanted organs. We look forward to generating further insights
into the therapeutic potential of tegoprubart in comparison to the
standard of care, while continuing to run our Phase 1b in parallel,
positioning us to report multiple data updates over the next 18
months.”
Eledon previously reported results from the first three
participants dosed in the Company’s ongoing Phase 1b trial. Results
showed no incidence of acute rejection and strong graft function
observed in all three participants, with mean eGFRs above
historical averages with standard of care at measured timepoints
out to 31 weeks. The trial currently has enrolled 11 participants
to date and will continue in parallel with the Phase 2 BESTOW
trial. Eledon expects to report additional data from the ongoing
Phase 1b study during the American Society of Nephrology’s Kidney
Week 2023, taking place November 2-5, 2023 in Philadelphia.
Visit clinicaltrials.gov (NCT05983770) for more information
about the BESTOW trial.
About Eledon Pharmaceuticals and
tegoprubart
Eledon Pharmaceuticals is a clinical stage biotechnology
company with immunology expertise that is developing therapies to
protect and prevent rejection of transplanted organs, as well as to
treat amyotrophic lateral sclerosis (ALS). The Company’s lead
compound in development is tegoprubart, an anti-CD40L antibody with
high affinity for CD40 Ligand, a well-validated biological target
with broad therapeutic potential. Eledon is headquartered in
Irvine, California. For more information, please visit the
Company’s website at www.eledon.com.
Follow Eledon Pharmaceuticals on social media: LinkedIn;
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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
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including: risks relating to the safety and efficacy of our drug
candidates; risks relating to clinical development timelines,
including interactions with regulators and clinical sides, as well
as patient enrollment; risks relating to costs of clinical trials
and the sufficiency of the company’s capital resources to fund
planned clinical trials; and risks associated with 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
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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
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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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