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
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 millionin 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 millionupon 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 Instituteto secure financing from the Juvenile Diabetes Research Foundation(JDRF) and The Cure Allianceto 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
Anticipated 2024 Milestones
- First half of 2024: Report updated interim clinical data from the ongoing Phase 1b trial of tegoprubart in kidney transplantation.
- First half of 2024: Dose the 12th participant in the Phase 2 BESTOW trial. Upon the dosing of the 12th participant, the Company will have completed both clinical development milestones related to the second financing tranche from the private placement announced on
May 1, 2023.
- End of 2024: Complete enrollment in the Phase 2 BESTOW trial of tegoprubart in kidney transplantation.
- 2024: Dose the first islet cell transplant participant for the treatment of type 1 diabetes at the
University of Chicago Transplantation Institute.
About Eledon Pharmaceuticals and tegoprubart
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.
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Source: Eledon Pharmaceuticals
Source: Eledon Pharmaceuticals, Inc.