Eledon Pharmaceuticals Highlights Recent Business Milestones and Provides 2024 Outlook

Reported updated data from ongoing Phase 1b trial in kidney transplantation demonstrating tegoprubart treatment successfully prevented kidney transplant rejection and was generally safe and well-tolerated 

Dosed first participants in Phase 2 BESTOW trial in kidney transplantation 

Tegoprubart dosed in second-ever pig to human xenotransplant procedure

IRVINE, Calif., Jan. 04, 2024 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced a summary of 2023 accomplishments and provided guidance for anticipated upcoming 2024 milestones.

2023 Key Highlights

• Reported updated data from ongoing Phase 1b trial evaluating tegoprubart for prevention of rejection in kidney transplantation. Data from 11 trial participants demonstrated that tegoprubart was generally safe and well-tolerated in patients undergoing kidney transplantation, with aggregate mean estimated glomerular filtration rate (eGFR) above 70 mL/min/1.73m² at all reported time points after 90 days post-transplant. Amended the Phase 1b trial protocol to add a second cohort, now allowing enrollment of up to 24 trial participants who are undergoing kidney transplantation.
• Dosed first participants in Phase 2 BESTOW trial assessing tegoprubart head-to-head with tacrolimus for the prevention of rejection in kidney transplantation.
• Dosed tegoprubart in second-ever transplant of genetically modified heart from a pig to a human.
• Completed financing of up to $185 million, with $35 million in upfront funding and additional aggregate financing of up to $105 million, subject to achieving clinical development milestones, volume weighted share price levels, and trading volume conditions, as well as up to an additional $45 million upon exercise of warrants. If all commitments are met, the financing is expected to be sufficient to fund the Company through the completion of the Phase 2 BESTOW trial, subject to the achievement of specified milestones, including clinical development enrollment targets.
• Partnered with the University of Chicago Transplantation Institute to secure financing from the Juvenile Diabetes Research Foundation (JDRF) and The Cure Alliance to fund an investigator sponsored study in pancreatic islet cell transplantation in participants with type 1 diabetes. Tegoprubart treatment will be evaluated for the prevention of transplant rejection.
• Strengthened leadership team with appointment of Eliezer Katz, M.D., FACS as Chief Medical Officer and strengthened board of directors with appointment of Allan Kirk, M.D., Ph.D. and James Robinson.

“Eledon made significant progress in 2023 on multiple fronts, highlighted by the presentation of the first clinical evidence of tegoprubart’s potential to prevent organ rejection while producing robust improvements in eGFR and maintaining a favorable safety profile. We were also honored to play an important role in the second-ever transplant of a genetically modified heart from a pig to a human with the use of tegoprubart as part of the patient’s cornerstone immunosuppressive regimen,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “In the coming year, we look forward to building upon the promising results from our tegoprubart kidney transplant Phase 1b trial, generating additional long-term data from the Phase 1b extension study, and completing enrollment in our Phase 2 BESTOW trial.”