Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today
reported results from the Company’s ongoing Phase 1b open-label
trial evaluating tegoprubart for the prevention of rejection in
patients undergoing de novo kidney transplantation. Results were
presented at the American Society of Nephrology Kidney Week 2023
Annual Meeting taking place in Philadelphia, PA from November 2-5,
2023.
“We are excited to present updated safety and efficacy results
from our ongoing Phase 1b trial which continue to support the
potential of tegoprubart as a novel kidney transplant
immunosuppressive therapy to prevent rejection and better preserve
organ function without many of the side effects associated with
tacrolimus, the current standard of care,” said David-Alexandre C.
Gros, M.D., Chief Executive Officer. “We remain committed to the
transplant community who are in urgent need of better treatment
options, and we look forward to continuing this study in parallel
with our Phase 2 BESTOW study initiated earlier this year.”
At the time of data submission, results from the 11 participants
in the Phase 1b trial demonstrated that tegoprubart is generally
safe and well-tolerated in patients undergoing kidney
transplantation. There have been no cases of hyperglycemia, new
onset diabetes, tremor, or cytomegalovirus infection commonly seen
with tacrolimus. One participant experienced a mild T cell mediated
rejection (Banff score 1a) on day 99. This patient was treated for
the rejection and remains in the study. There were no cases of
graft loss or death.
Aggregate mean estimated glomerular filtration rate (eGFR) – a
measure of kidney function – was above 70 mL/min/1.73m2 at all
reported time points after day 90. Historical studies have reported
average eGFRs generally in the low 50 mL/min/1.73m2 range during
the first year after kidney transplant using standard of care. One
participant has completed the study with an eGFR of 91 at one year
(day 374) and is now enrolled in a Phase 2 open-label extension
(OLE) study, which will evaluate the long-term safety,
pharmacokinetics, and efficacy of tegoprubart in participants who
have completed one year of treatment in either the ongoing Phase 1b
or Phase 2 BESTOW study.
“In this Phase 1b trial, patients treated with tegoprubart
demonstrated robust improvements in eGFR with a strong safety
profile,” said Dr. John S. Gill, MD, Professor of Medicine at
the University of British Columbia, St. Paul’s Hospital, Vancouver,
Canada, and Principal Investigator of the study. “These
results further support the promise of CD40L costimulatory blockade
in organ transplantation. I look forward to additional
readouts from this study in 2024.”
The Phase 1b open-label study has enrolled 11 participants who
underwent kidney transplantation in Canada, Australia, and the
United Kingdom. Each participant received rabbit antithymocyte
globulin (ATG) induction and a maintenance regimen consisting of
tegoprubart, mycophenolate mofetil, and corticosteroids. The
primary endpoint of the study is safety. Other endpoints include
characterizing the pharmacokinetic profile of tegoprubart, the
incidence of biopsy proven rejection, and eGFR.
In September, Eledon announced that the first participant had
been dosed in the Company’s Phase 2 BESTOW trial evaluating
tegoprubart for the prevention of organ rejection in patients
receiving a kidney transplant. The multicenter, two-arm, active
comparator clinical study is enrolling approximately 120
participants undergoing kidney transplantation in the United States
and other countries to evaluate the safety, pharmacokinetics, and
efficacy of tegoprubart compared to the calcineurin inhibitor
tacrolimus. The BESTOW trial's primary endpoint is designed to test
the potential superiority of tegoprubart vs. tacrolimus in post
kidney transplant kidney function at 12 months as measured by eGFR.
The Company expects to complete enrollment at the end of 2024.
Full details on the poster presentations are below:
Title: Tegoprubart for the prevention of
rejection in kidney transplant: update of emerging data from an
ongoing trialPresenter: Steve Perrin,
Ph.D., President and Chief Scientific
Officer, Eledon PharmaceuticalsPoster
Number: TH-PO835Session
Title: Transplantation: Clinical - I
[PO2102-1] Session Date and
Time: November 2, 2023 from 10:00 AM to
12:00 PM EDT
Following the presentation, a copy of the poster will be
available on the Investor section of the Company’s website
at https://ir.eledon.com/news-and-events/publications-and-presentations.
Conference Call
Eledon will hold a conference call today, November 2,
2023 at 5:00 p.m. Eastern Time to discuss the
updated trial results. The dial-in numbers are 1-888-886-7786 for
domestic callers and 1-416-764-8658 for international callers. The
conference ID is 66816567. A live webcast of the conference call
will be available on the Investor Relations section of the
Company's website at www.eledon.com. The webcast will be
archived on the website following the completion of the call.
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 CD40 Ligand, a
well-validated biological target within the costimulatory
CD40/CD40L cellular pathway. 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.
Follow Eledon Pharmaceuticals on social
media: LinkedIn; Twitter
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, 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; 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
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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