Stimulated by the extremely promising preliminary results from our pilot study involving 12 patients, Eledon Pharmaceuticals has submitted an IND application to the U.S. Food and Drug Administration (FDA). This represents the first and a very important step toward launching by Eledon a multicenter clinical trial evaluating tegoprubart in islet transplantation as a strategy to reverse diabetes in patients with type 1 diabetes (T1D).
Successful completion of this trial could ultimately lead to FDA approval of tegoprubart and make this novel therapy available as part of standard clinical care, with insurance coverage for both cadaveric and stem cell-derived islet transplantation. Beyond helping many patients with T1D, this approach may also accelerate the development and testing of new strategies aimed at improving the safety, efficacy, and broader applicability of islet transplantation on the path toward a functional cure for diabetes.
Congratulations to Eledon on taking this important next step.
Timeline: The FDA typically has 30 days to review an IND submission, provide comments, and request additional information before the study may proceed. Following IND clearance, Eledon will select participating transplant centers. Each center will then need to obtain approval from its local Institutional Review Board (IRB) before the trial can begin.
Please stay tuned for future announcements from Eledon, as patient enrollment cannot begin at this time.