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Also known as Prochymal®, Prochymal™, PROCHYMAL®
Prochymal · 8 trials · 10 indications
Crohn's Disease Activity Index (CDAI) at or below 150 and increase in IBDQ
Treatment was considered a success if all of the following conditions were met: Achieved induction of a complete response (CR) within 28 days after first infusion; CR followed by 28 days maintenance of a clinically meaningful response defined as the response that did not require an increase in corticosteroid dose (methylprednisolone doses \>2 milligram/kilogram/day \[mg/kg/d\] or prednisone doses \>2.5 mg/kg/d) for more than 7 consecutive days; Did not require second line/escalation therapy through Study Day 56; and survived 90 study days.
A complete response was defined as complete resolution of all clinical signs of Graft versus host disease (GVHD)- that had to be maintained for at least 28 consecutive days (durable complete response \[DCR\]) within 100 days post first infusion.
Responses included complete response (CR), partial response (PR), failure to respond. CR is defined as a complete resolution of graft-versus-host disease (GVHD). PR is defined as improvement in at least one organ by at least one full stage in the absence of progression in any other organ, or resolution of GVHD in at least one organ with a need for additional treatment because of abnormalities persisting in another organ. Failure to respond is defined as progression of GVHD.
| Arm | Type | Description |
|---|---|---|
| Prochymal® | EXPERIMENTAL | Infusions of Prochymal on days 42-45, 84-87, and 126-129 after first infusion in Protocol 603. Each infusion of PROCHYMAL (remestemcel-L) will contain 200 million cells. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive 6 infusions of placebo-matching Prochymal® intravenously (IV) during the first 4 weeks of the study. The first infusion will be administered within 72 hours of the start of systemic corticosteroid therapy. Participants will receive 4 infusions during the first 2 weeks (twice weekly at least 3 days apart), followed by 2 infusions administered once weekly over the subsequent 2 weeks up to Day 28. |
| Prochymal® 2x10^6 hMSC/kg | ACTIVE_COMPARATOR | Participants will receive 6 infusions of Prochymal® 2x10\^6 human mesenchymal stem cells (hMSC)/kg IV during the first 4 weeks of the study. The first infusion will be administered within 72 hours of the start of systemic corticosteroid therapy. Participants will receive 4 infusions during the first 2 weeks (twice weekly at least 3 days apart), followed by 2 infusions administered once weekly over the subsequent 2 weeks up to Day 28. |
| Prochymal® - Low dose | ACTIVE_COMPARATOR | Participants will receive a total dose of Prochymal® 600 x 10\^6 cells, IV infusion, on four days, once daily. |
| Prochymal® - High dose | ACTIVE_COMPARATOR | Participants will receive a total dose of Prochymal® 1200 x 10\^6 cells, IV infusion, on four days, once daily. |
| Prochymal | EXPERIMENTAL | PROCHYMAL® |
| Prochymal™ | EXPERIMENTAL | Participants received Prochymal™ a total of 400×10\^6 cells, intravenous (IV) infusions on Days 0, 30, 60, and 90. |
| Name | Type | Description |
|---|---|---|
| Prochymal® | DRUG | PROCHYMAL will be administered IV in a total volume of 300 ml (200 million cells) at a rate of 4-6 ml/minute. Treatments will be administered on Days 42-45, Days 84-87, and Days 126-129 following first infusion in Protocol 603. |
| Placebo | OTHER | Placebo-matching Prochymal® intravenous infusion. |
| Corticosteroid | OTHER | Administration will be intravenously as prescribed by the caregiver. |
| Standard of Care for GVHD | DRUG | Institutionally defined standard of care (e.g., maintenance of steroid treatment and the addition of a second-line therapy) |
| Prochymal™ | DRUG | IV infusion of ex- vivo cultured adult human mesenchymal stem cells. |
| Prochymal | DRUG | Intravenous infusion of ex-vivo cultured adult human mesenchymal stem cells |
Inclusion Criteria: * Participant must have qualified for, enrolled in, and provided written informed consent form (ICF) and authorization for use and disclosure of protected health information (PHI) for Protocol 603 after the August 3, 2010. * Participant successfully completed all screening asses...
Top 11 of 13 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Sanofi SA Sponsored ADR | SNY | 6 | PHASE3 | Duvakitug, SAR441566, balinatunfib, SAR442970 |
| Eli Lilly and Company | LLY | 8 | PHASE3 | Mirikizumab, Tirzepatide, MORF-057, LY4395089 |
| AbbVie, Inc. | ABBV | 14 | PHASE3 | Risankizumab, Upadacitinib, Lutikizumab, Trosunilimab, ABBV-8736 |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 16 | PHASE3 | Vedolizumab, Zasocitinib, Darvadstrocel |
| Johnson & Johnson | JNJ | 13 | PHASE3 | Ustekinumab, Guselkumab, Golimumab, JNJ-78934804, Icotrokinra |
| Merck & Co., Inc. | MRK | 2 | PHASE3 | Tulisokibart |
| AstraZeneca PLC | AZN | 2 | PHASE2 | AZD7798 |
| Disc Medicine, Inc. | IRON | 1 | PHASE2 | DISC-0974 |
| Spyre Therapeutics, Inc | SYRE | 1 | PHASE2 | SPY001, SPY002, SPY003 |
| Abivax SA Sponsored ADR | ABVX | 1 | PHASE2 | Obefazimod |
| Palisade Bio, Inc. | PALI | 1 | PHASE1 | PALI-2108 |
Prochymal is an investigational cell-based therapy developed by Mesoblast Limited for several inflammatory and immune-mediated conditions. It has been studied in Crohn's disease, graft versus host disease, myocardial infarction, chronic obstructive pulmonary disease, and type 1 diabetes mellitus. It is not approved and remains in clinical development.
Prochymal has been studied for treatment-refractory moderate-to-severe Crohn's disease, graft versus host disease, acute myocardial infarction, chronic obstructive pulmonary disease, and recently diagnosed type 1 diabetes mellitus. These are investigational uses; Prochymal is not approved for any indication and remains in clinical development.
Prochymal is developed by Mesoblast Limited, an Australian regenerative medicine company that trades under the ticker MESO. Mesoblast is the sponsor of the clinical trials evaluating Prochymal across its studied indications.
Prochymal has reached Phase 3 in Crohn's disease, with a completed Phase 3 trial, and has completed Phase 2 studies in myocardial infarction, type 1 diabetes mellitus, and chronic obstructive pulmonary disease. It is investigational and has not been approved for any indication.
Prochymal has been evaluated in completed trials including NCT01233960 in treatment-refractory moderate-to-severe Crohn's disease, NCT00877903 in acute myocardial infarction, NCT00690066 in recently diagnosed type 1 diabetes mellitus, and NCT00683722 in moderate to severe chronic obstructive pulmonary disease. All four studies are completed.