Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SL-325 · 2 trials · 2 indications
The proportion of participants who achieve endoscopic response, as defined by a ≥50% decrease in Simplified Endoscopic Score for Crohn's disease (SES-CD) from baseline.
Incidence and severity of treatment-emergent adverse events
| Arm | Type | Description |
|---|---|---|
| SL-325 high dose | EXPERIMENTAL | - |
| SL-325 mid dose | EXPERIMENTAL | - |
| SL-325 low dose | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| SAD: SL-325 | EXPERIMENTAL | Participants will receive a single dose of SL-325 in escalating dose cohorts |
| SAD: Placebo | PLACEBO_COMPARATOR | Participants will receive a single dose of placebo (normal saline) |
| MAD: SL-325 | EXPERIMENTAL | Participants will receive a three doses of SL-325 in escalating dose cohorts |
| MAD: Placebo | PLACEBO_COMPARATOR | Participants will receive a three doses of placebo (normal saline) |
| Name | Type | Description |
|---|---|---|
| SL-325 | DRUG | SL-325 administered intravenously |
| Placebo | DRUG | Placebo administered intravenously |
| Placebo (Normal Saline) | OTHER | Normal saline |
Key Inclusion Criteria: * A diagnosis of Crohn's disease confirmed by endoscopy and histopathology ≥ 3 months prior to Screening * Moderately to severely active CD as defined by CDAI of ≥ 220 and ≤ 450 * SES-CD score ≥ 6 if ileocolonic or colonic disease, or ≥ 4 if isolated ileal disease, as assess...
| 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 |
| Abivax SA Sponsored ADR | ABVX | 1 | PHASE2 | Obefazimod |
| Disc Medicine, Inc. | IRON | 1 | PHASE2 | DISC-0974 |
| Spyre Therapeutics, Inc | SYRE | 1 | PHASE2 | SPY001, SPY002, SPY003 |
| 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 |
SL-325 is an investigational small molecule being developed for Crohn's Disease. It is also being studied in healthy volunteers as part of early clinical testing. The drug is currently in Phase 2 development for Crohn's Disease, with a Phase 1 study in healthy volunteers also ongoing.
SL-325 targets DR3, a protein involved in immune signaling. By modulating DR3 activity, the drug is being investigated for its potential to treat Crohn's Disease, a chronic inflammatory condition of the gastrointestinal tract.
SL-325 is being developed by Shattuck Labs, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol STTK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in healthy volunteers and patients with Crohn's Disease.
SL-325 is in Phase 2 clinical development for Crohn's Disease. A Phase 1 study in healthy volunteers is also active but not recruiting. The drug is investigational and has not been approved by regulatory authorities.
SL-325 is being studied in two clinical trials. NCT07158437 is a Phase 1 study in healthy volunteers, with 72 participants, conducted in the United States. NCT07753850 is a Phase 2 study in Crohn's Disease patients, with 232 participants, which is not yet recruiting.
No alternative names for SL-325 have been disclosed. The drug is identified solely by its code name SL-325 in clinical trial registrations and company communications.