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Cx601 · 3 trials · 2 indications
Combined remission was defined as the closure of all treated external openings that were draining at baseline despite gentle finger compression and absence of collection(s) \>2 cm (in at least 2 dimensions) of the treated perianal fistula(s) confirmed by blinded central magnetic resonance imaging (MRI) assessment. Percentages are rounded off to whole number at the nearest decimal.
Combined Remission of perianal fistulising Crohn's disease defined as the clinical assessment of closure of all treated external openings (EO) that were draining at baseline despite gentle finger compression at week 24, and absence of collections \> 2 cm of the treated perianal fistulas confirmed by centrally blinded MRI assessment by week 24.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Placebo (saline) 24 milliliters (mL) was administered once by local injection. |
| Cx601 | EXPERIMENTAL | Cx601 expanded adipose-derived stem cells (eASCs) 120 million cells (5 million cells per mL) was administered once by local injection. |
| Treatment Arm | EXPERIMENTAL | Cx601 is a cell suspension in aseptic buffered solution containing human expanded adipose-derived stem cells (eASCs) of allogeneic origin in disposable vials with no preservative agents. The cells will be given at a dose of 120 million cells (5 million cells / mL) for intralesional injection. |
| Placebo-control group | PLACEBO_COMPARATOR | Placebo (saline solution) will be given also for intralesional injection at the same quantity (volume, 24 mL) and following the same schedule. |
| Name | Type | Description |
|---|---|---|
| Cx601 | DRUG | Cx601 eASCs intralesional injection. |
| Placebo | OTHER | Cx601 placebo-matching eASCs intralesional injection. |
| Saline solution | OTHER | 24 mL saline solution by intralesional injection |
Inclusion Criteria: 1. Signed informed consent. 2. Participants of either gender greater than or equal to (\>=) 18 years and less than or equal to (\<=) 75 years of age. 3. Participants with CD diagnosed at least 6 months prior to Screening visit in accordance with accepted clinical, endoscopic, hi...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Sanofi SA Sponsored ADR | SNY | 6 | PHASE3 | Duvakitug |
| Eli Lilly and Company | LLY | 8 | PHASE3 | Mirikizumab |
| AbbVie, Inc. | ABBV | 14 | PHASE3 | Risankizumab, Risankizumab On-Body Injector |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 16 | PHASE3 | Vedolizumab |
| Johnson & Johnson | JNJ | 13 | PHASE3 | Ustekinumab |
| 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 |
| Novartis AG Sponsored ADR | NVS | 1 | - | Undisclosed |
| Amgen Inc. | AMGN | 1 | N/A | Undisclosed |
| TScan Therapeutics, Inc. | TCRX | 1 | - | Undisclosed |
Cx601 is an investigational cell therapy being studied for the treatment of complex perianal fistulas in patients with Crohn's Disease. It is an adult allogeneic expanded adipose-derived stem cell product. The drug is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
Cx601 is a cell therapy composed of adult allogeneic expanded adipose-derived stem cells. Rather than targeting a specific molecular receptor, the stem cells are intended to modulate the inflammatory response and promote tissue healing in perianal fistulas associated with Crohn's Disease.
Cx601 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company is conducting Phase 3 clinical trials to evaluate the safety and efficacy of this cell therapy for complex perianal fistulas in Crohn's Disease patients.
Cx601 is in Phase 3 clinical development. It is an investigational therapy and has not received FDA approval. The drug is being studied for the treatment of complex perianal fistulas in patients with Crohn's Disease, with three completed clinical trials involving a total of 870 participants.
Cx601 has completed three clinical trials. NCT01372969 was a Phase 1 study in Spain with 24 patients. NCT01541579 was a Phase 3 trial with 278 patients across Europe and Israel. NCT03279081 was a Phase 3 trial with 568 patients in the US, Canada, Europe, and other countries.
Cx601 is an adult allogeneic expanded adipose-derived stem cell product. It is also referred to as eASC or eASC (expanded adipose-derived stem cells) in clinical trial documentation. The drug is being developed specifically for complex perianal fistulas in Crohn's Disease.