Eledon Announces Clinical Progress with Tegoprubart in the Prevention of Transplant Rejection

Rhea-AI Summary

Eledon Pharmaceuticals, Inc. announced the dosing of the first participant in a clinical trial at the University of Chicago Medicine using tegoprubart to prevent islet cell transplant rejection in type 1 diabetes patients. They also reported positive results from a Phase 1b trial for kidney transplant rejection prevention. Tegoprubart demonstrated safety and effectiveness in protecting organ function in kidney transplant patients with no cases of graft loss or death. The company plans to present the data at the American Transplant Congress. Eledon is conducting multiple trials to evaluate tegoprubart for preventing organ rejection in kidney transplant recipients, showcasing its potential as a promising treatment option.

Positive

• Tegoprubart demonstrated safety and effectiveness in preventing kidney transplant rejection, with no cases of graft loss or death reported.

• The updated data from the ongoing Phase 1b trial showed positive results, with all reported time points indicating kidney function above 60 mL/min/1.73m2 and post-transplant eGFRs above 90 mL/min/1.73m2 for subjects completing 12 months on therapy.

• The collaboration with the University of Chicago Transplant Institute for the investigator-sponsored trial in pancreatic islet cell transplantation with grants from JDRF and Cure Alliance highlights Eledon's commitment to advancing innovative treatments for transplant patients.

Negative

• Three subjects discontinued the study due to side effects such as hair loss, fatigue, viral infection, and rejection, indicating potential challenges with long-term tolerability and safety of tegoprubart.

• The use of current standard anti-rejection medications like calcineurin inhibitors has limitations due to associated toxicity, posing a potential hurdle for tegoprubart to replace existing therapies.

Insights

Medical Research Analyst

The dosing of the first participant in a clinical trial using tegoprubart, alongside the positive direction of Phase 1b trial results, marks a notable development in the treatment and management of transplant rejection. Tegoprubart's potential to prevent rejection while mitigating the adverse side effects commonly associated with traditional immunosuppressants could represent a pivotal shift in post-transplant care. Historical eGFR averages cited post-transplant are significantly lower than those shown in the subjects who received tegoprubart, suggesting a potential improvement in kidney function preservation. This could translate to better patient outcomes and potentially longer-term graft survival, which are critical success factors in transplantation. However, it's important to note that the discontinuation of participation by three subjects due to various reasons including side effects and rejection indicates that there is variability in patient response to tegoprubart. Continuous monitoring of trial participant's responses is essential to duly assess the drug's efficacy and safety profile.

Biotech Financial Analyst

From an investment standpoint, Eledon Pharmaceuticals' announcement could influence investor sentiment positively, especially given the preliminary positive safety and efficacy data of tegoprubart in transplant rejection prevention. The company's collaboration with the University of Chicago and grant support from organizations like the JDRF and Cure Alliance add a layer of credibility and financial backing that may encourage investor confidence. However, as with all clinical trials, there are inherent risks and the impact on the company's stock will likely hinge on continued positive results, regulatory approvals and the ability to successfully bring the product to market. Moreover, the eventual market size and competitive landscape of anti-rejection treatments will be significant factors in determining the long-term financial impact of tegoprubart on Eledon's valuation. Investors should closely monitor further trial results and regulatory developments as they can significantly impact the stock's performance.

First participant dosed in clinical trial at University of Chicago Medicine assessing the use of tegoprubart to prevent islet cell transplant rejection in patients with type 1 diabetes

Company reports updated data from ongoing Phase 1b trial evaluating tegoprubart for prevention of rejection in kidney transplantation

IRVINE, Calif., May 07, 2024 (GLOBE NEWSWIRE) -- 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.

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, 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 Jasper
Gilmartin Group
(858) 525 2047
stephen@gilmartinir.com

Media Contact:

Jenna Urban
Berry & Company Public Relations
(212) 253 8881
jurban@berrypr.com

Source: Eledon Pharmaceuticals

FAQ

What is tegoprubart and its purpose?

Tegoprubart is a novel anti-CD40L antibody developed by Eledon Pharmaceuticals to prevent transplant rejection in patients with type 1 diabetes and kidney transplant recipients.

What were the results of the Phase 1b trial for kidney transplant rejection prevention?

The Phase 1b trial demonstrated that tegoprubart is generally safe and well-tolerated, with all reported time points showing kidney function above 60 mL/min/1.73m2 and post-transplant eGFRs above 90 mL/min/1.73m2 for subjects completing 12 months on therapy.

What challenges did the study participants face during the trial?

Three subjects discontinued the study due to side effects like hair loss, fatigue, viral infection, and rejection, indicating potential challenges with the long-term tolerability and safety of tegoprubart.

With whom did Eledon collaborate for the investigator-sponsored trial in pancreatic islet cell transplantation?

Eledon collaborated with the University of Chicago Transplant Institute for the investigator-sponsored trial, supported by grants from the Juvenile Diabetes Research Foundation (JDRF) and the Cure Alliance.