Eledon Presents Updated Data from Ongoing Phase 1b Trial Evaluating Tegoprubart for Prevention of Rejection in Kidney Transplantation
Eledon Pharmaceuticals presented updated data from its ongoing Phase 1b trial of tegoprubart for preventing organ rejection in kidney transplant patients at the American Transplant Congress.
The study involved 13 participants and demonstrated a consistent mean eGFR of 70.5 mL/min/1.73m² at all reported time points post-transplant. Notably, two participants had mean eGFRs above 90 mL/min/1.73m² at 12 months post-transplant.
Tegoprubart was generally well tolerated, with no cases of hyperglycemia, new onset diabetes, or tremor, commonly seen with current calcineurin inhibitor-based treatments. Three participants discontinued the study due to adverse effects, including hair loss, viral infection, and rejection.
Eledon is also running a Phase 2 BESTOW trial with expected enrollment completion by year-end 2024.
- Mean eGFR of 70.5 mL/min/1.73m² post-transplant is higher than the typical 50 mL/min/1.73m² from standard treatments.
- Two participants showed eGFRs above 90 mL/min/1.73m² at 12 months post-transplant.
- No cases of hyperglycemia, new onset diabetes, or tremor were reported.
- No instances of graft loss or death have occurred.
- Phase 2 BESTOW trial enrollment is expected to complete by the end of 2024.
- Three participants discontinued the study due to adverse effects such as hair loss, viral infection, and rejection.
- The study sample size was to 13 participants, which may limit the generalizability of the results.
Insights
The results from Eledon's ongoing Phase 1b trial for tegoprubart in kidney transplant patients show a compelling improvement in maintaining kidney function post-transplant. The reported mean eGFR above 60 mL/min/1.73m² at all time points after day 30 and an overall mean of 70.5 mL/min/1.73m² highlight a significant advance over the traditional calcineurin inhibitors, which average around 50 mL/min/1.73m². This suggests potential in minimizing graft rejection while maintaining organ function. Furthermore, the absence of common side effects associated with current therapies, like hyperglycemia and tremors, makes tegoprubart a more tolerable option for patients.
From a clinical perspective, the fact that two participants demonstrated exceptional kidney function (eGFR above 90 mL/min/1.73m²) at one year is noteworthy. However, the small sample size (13 participants) means these findings require validation in larger studies. The continued enrollment in the Phase 2 BESTOW trial will be critical for confirming these preliminary findings and determining long-term efficacy and safety.
In conclusion, tegoprubart's potential to replace current immunosuppression therapy looks promising but needs thorough validation. For retail investors, the critical takeaway is that while these early results are positive, the journey to market requires further trials and regulatory approval, which introduces both opportunities and risks.
From a financial perspective, Eledon's updated data on tegoprubart could significantly impact the company's valuation. The promising efficacy and safety profile may spark investor interest, given the potential to address the unmet needs in kidney transplantation. Historically, the market for immunosuppressive drugs is lucrative, with high barriers to entry. If tegoprubart continues to show superior performance and safety, Eledon might capture a substantial share of this market.
However, investors should consider the developmental stage of tegoprubart. Being in Phase 1b, with Phase 2 enrollment ongoing, suggests a long road ahead before any commercial success. The process involves significant costs and regulatory hurdles, which can affect the company's financial health. Investors should keep an eye on cash burn rates, funding needs and any potential dilution of equity due to new funding rounds.
In summary, while the data is encouraging and could lead to a positive reevaluation of Eledon's stock, it is essential to balance this with the associated risks and timelines inherent in drug development. The potential for future profitability exists but remains contingent on successful trial completions and market approvals.
Data from 13 participants presented at the American Transplant Congress continue to support safety and tolerability profile of tegoprubart
Overall mean eGFR of all reported time points after day 30 post-transplant of 70.5 mL/min/1.73m²
Mean eGFR measured above 60 mL/min/1.73m² at all reported time points after day 30 post-transplant
IRVINE, Calif., June 03, 2024 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today presented updated data from the Company’s ongoing open-label Phase 1b trial and open-label extension study evaluating tegoprubart for the prevention of organ rejection in kidney transplant patients. Results from the poster, titled “Biomarkers of Inflammation and eGFR in an Ongoing Phase 1B Study of an Anti-CD40L Antibody Tegoprubart, for the Prevention of Rejection in Kidney Transplant,” were presented at the American Transplant Congress (ATC) taking place in Philadelphia, PA from June 1-5, 2024.
“Eledon continues to build a robust set of encouraging results demonstrating the safety and efficacy of tegoprubart in kidney transplant recipients in our Phase 1b trial,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “Calcineurin inhibitors, the current standard of care, do not adequately serve the transplant community due to frequent and difficult–to-manage side effects. By contrast, tegoprubart’s observed clinical profile to date gives us confidence in its potential to supplant calcineurin inhibitors as a next-generation immunosuppression agent for patients who have received a new kidney. We look forward to accruing incremental data through the ongoing Phase 1b and open-label extension studies while continuing to enroll in our Phase 2 BESTOW trial, with enrollment completion anticipated by the end of the year.”
As of the April 2024 cutoff date, updated data from the 13 participants in the ongoing Phase 1b trial support tegoprubart’s potential to protect organ function in patients undergoing kidney transplantation. Data from historical studies using standard of care, calcineurin inhibitor-based immunosuppression therapy typically report aggregate mean estimated glomerular filtration rates (eGFRs) of approximately 50 mL/min/1.73m2 during the first year after kidney transplant. In the ongoing Phase 1b trial, mean eGFR was above 60 mL/min/1.73m² at each reported time points after day 30, with an overall mean eGFR of 70.5 mL/min/1.73m² for all the reported time points after day 30 post-transplant. Two participants completed 12 months on therapy post-transplant, and both demonstrated mean eGFRs above 90 mL/min/1.73m² at one-year post-transplant.
Results demonstrated that tegoprubart is generally safe and well tolerated in patients undergoing de novo kidney transplantation. Three subjects have discontinued the study due to hair loss and fatigue, viral infection, and rejection, respectively. There have been no cases of hyperglycemia, new onset diabetes, or tremor, all of which are side effects often associated with standard of care immunosuppression therapy. There have been no cases of graft loss or death.
Eledon is currently conducting a Phase 1b trial (NCT05027906), a Phase 2 trial (BESTOW; 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.
A copy of the ATC poster can be found on the Investor section of the Company’s website at https://ir.eledon.com/news-and-events/publications-and-presentations.
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 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 the significance of the mean eGFR reported in Eledon's Phase 1b trial?
Were there any adverse effects reported in the Eledon Phase 1b trial for tegoprubart?
How does tegoprubart's safety profile compare to standard treatments?
When is the enrollment for Eledon's Phase 2 BESTOW trial expected to complete?
Were any participants in the Eledon Phase 1b trial free from graft loss or death?
