Eledon Announces Clinical Progress with Tegoprubart in the Prevention of Transplant Rejection
May 07 2024 - 7:05AM
Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today
announced that the first participant in an investigator-led
clinical trial has received an islet cell transplant and is being
treated with a novel immunosuppression regimen including
tegoprubart, the company’s novel anti-CD40L antibody, which is in
development for the prevention of pancreatic islet cell transplant
rejection in patients with type 1 diabetes. The study is being
conducted by the research team at University of Chicago Medicine’s
Pancreatic and Islet Transplant Program. Separately, the company
reported updated data from its ongoing Phase 1b trial demonstrating
tegoprubart successfully prevented kidney transplant rejection and
was generally safe and well-tolerated.
In January 2024, Eledon announced a collaboration with the
University of Chicago Transplant Institute for an investigator
sponsored trial in pancreatic islet cell transplantation in
patients with type 1 diabetes (NCT06305286). Eledon is supplying
tegoprubart as a cornerstone component of the immunosuppressive
regimen for trial participants and tegoprubart is being evaluated
for the prevention of transplant rejection in the trial. Funding
for the study includes grants from the Juvenile Diabetes Research
Foundation (JDRF) and the Cure Alliance.
“There is clinical evidence from our studies and
others conducted by the National Institute of Health’s Clinical
Islet Transplantation Consortium that demonstrate islet cell
transplantation may reverse diabetes by eliminating the need for
exogenous insulin and reinstating metabolic control in selected
patients with difficult to control type 1 diabetes. However, the
required use of current standard of care anti-rejection
medications, specifically calcineurin inhibitors, has limited the
benefit of these procedures due to well-known associated toxicity
to the islets, nephrotoxicity, neurotoxicity and risk of
hypertension. We hope that tegoprubart will effectively protect
islets from rejection without side effects related to current
standard therapy,” said Piotr Witkowski, M.D., Ph.D., Director,
Pancreatic and Islet Transplant Program, University of Chicago
Medicine, and principal investigator of the trial with John Fung,
M.D., Ph.D.
“This first islet cell transplant as part of the University of
Chicago trial is a significant milestone in our efforts to advance
tegoprubart as a novel and much-needed treatment option for
transplant patients,” said Steven Perrin, Ph.D., President and
Chief Scientific Officer of Eledon. “We look forward to continuing
our work with the University of Chicago team and further studying
tegoprubart and its potential ability to prevent islet cell
transplant rejection that may lead to improved outcomes and quality
of life for people living with type 1 diabetes.”
The company also announced updated data as of April 2024 from 13
participants in the ongoing Phase 1b trial evaluating tegoprubart
for the prevention of rejection in kidney transplantation. Results
demonstrated that tegoprubart is generally safe and well-tolerated
and support tegoprubart’s potential to protect organ function in
patients undergoing kidney transplantation. Aggregate mean
estimated glomerular filtration rate (eGFR) – a measure of kidney
function – measured above 60 mL/min/1.73m2 at all reported time
points after day 30. Two subjects completed 12 months on therapy
post-transplant and both demonstrated mean eGFRs above 90
mL/min/1.73m2 at one year. Historical studies using standard of
care immunosuppression therapy have reported average eGFRs
generally in the low 50 mL/min/1.73m2 range during the first year
after kidney transplant. To date, three subjects discontinued the
study because of hair loss and fatigue, viral infection, and
rejection, respectively. There have been no cases of graft loss or
death. The company plans to present this data at the upcoming
American Transplant Congress in Philadelphia, PA, in early June
2024.
Eledon is currently conducting a Phase 1b trial (NCT05027906),
the Phase 2 BESTOW trial (NCT05983770), 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 islet cell
transplantation or kidney transplantation, the company’s capital
resources and ability to finance planned clinical trials, 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 sides, 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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