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Remestemcel-L-rknd · 1 trial · 1 indication
The primary clinical endpoint is overall response at Day 28 post-randomization. Overall response is defined as achieving a PR or CR on Day 28 post-randomization without requirement for new intervening systemic immunosuppressive therapies
| Arm | Type | Description |
|---|---|---|
| Remestemcel-L-rknd | EXPERIMENTAL | Remestemcel-L will be administered as intravenous infusions |
| Placebo | PLACEBO_COMPARATOR | PTM will be administered as intravenous infusions |
| Name | Type | Description |
|---|---|---|
| Remestemcel-L-rknd | DRUG | Remestemcel-L is comprised of ex-vivo cultured adult human MSC |
| Placebo | OTHER | Placebo is infusion based to be given at the same points as remestemcel-L-rknd |
Inclusion Criteria: 1. Age 18 years or older at the time of enrollment. 2. Able to take oral medications 3. Have Grade III-IV SR-aGVHD at the time of enrollment, defined as aGVHD resistant to high dose corticosteroids at a dose of ≥ 1 mg/kg/day methylprednisolone (or equivalent), given alone or in ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Incyte Corporation | INCY | 10 | PHASE3 | INCA034176 |
| Sanofi SA Sponsored ADR | SNY | 2 | PHASE3 | Belumosudil, Prednisone, Prednisolone |
| Johnson & Johnson | JNJ | 1 | PHASE3 | Ibrutinib |
| Syndax Pharmaceuticals Inc | SNDX | 1 | PHASE2 | Axatilimab |
| Theriva Biologics, Inc. | TOVX | 1 | PHASE1 | Undisclosed |
Remestemcel-L-rknd is an investigational therapy being studied for the treatment of steroid-refractory acute graft-versus-host disease (GVHD), a complication that can occur after stem cell transplantation. It is currently in Phase 3 clinical development for this condition.
Remestemcel-L-rknd is being developed by Mesoblast Limited, a biopharmaceutical company. Mesoblast is listed on the stock exchange under the ticker symbol MESO.
Remestemcel-L-rknd is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. It is being studied for the treatment of steroid-refractory acute graft-versus-host disease.
Remestemcel-L-rknd is being evaluated in a Phase 3 clinical trial with the identifier NCT07568535. This is a randomized, double-blind, placebo-controlled, multicenter study that adds Remestemcel-L-rknd to ruxolitinib for patients with grade III-IV steroid-refractory acute graft-versus-host disease. The trial is not yet recruiting and aims to enroll 180 participants.
Yes, Remestemcel-L-rknd is classified as a small molecule drug. It is being investigated for its potential role in treating graft-versus-host disease, an immunological condition.