Clinical TrialMay 27, 2026, 07:57 AM
NewcelX Schedules FDA Pre-IND Meeting for Type 1 Diabetes Trial
AI Summary
NewcelX Ltd. announced the submission of a Pre-Investigational New Drug (Pre-IND) briefing package to the FDA and has scheduled a Pre-IND meeting for the last week of June. This meeting is a pivotal step to advance NCEL-101, an enriched stem cell-derived islet product, into a First-In-Human clinical trial for type 1 diabetes. The treatment combines NCEL-101 with Eledon Pharmaceuticals' tegoprubart, aiming for a potential functional cure for type 1 diabetes.
Key Highlights
- NewcelX scheduled a Pre-IND meeting with the FDA for its NCEL-101 type 1 diabetes treatment.
- The meeting aims to advance NCEL-101 to a First-In-Human (FIH) clinical trial.
- NCEL-101 will be combined with Eledon Pharmaceuticals' investigational immunomodulatory agent, tegoprubart.
- The Pre-IND meeting with the FDA is scheduled for the last week of June.
- Discussion topics include NCEL-101 manufacturing, preclinical development, and FIH clinical trial design.
- Tegoprubart has been used in over 100 transplant recipients across multiple FDA-cleared IND applications.
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