Approval Probability
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Adjusted LOA
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TEV-48574 · 1 trial · 2 indications
The MMS is a tool designed to measure disease activity for UC. It consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore as determined during central review. Each subscore was graded from 0 (normal) to 3 (severe). These individual subscores were summed up to give a total MMS ranging from 0 (normal or inactive disease) to 9 (severe disease), where higher scores indicated more severe disease activity. Clinical remission was defined as MMS ≤2 points with Mayo stool frequency subscore of 0 or 1, Mayo rectal bleeding subscore of 0, and centrally read endoscopic score of 0 or 1, where a score of 1 did not include "friability".
The SES-CD assessed the degree of inflammation. The SES-CD assesses the following 4 components: presence of ulcers, percentage of ulcerated surfaces, affected surface, and presence of strictures. Each of these components was scored on a scale of 0 (none/unaffected) to 3 (worst). In the SES-CD, each of these 4 components was assessed in the 5 segments: the rectum, sigmoid and left colon, transverse colon, right colon, and ileum. The SES-CD was the sum of the individual scores of each of the components across the 5 segments. The range of SES-CD scores was 0 (none) - 12 (severe) for each segment, and 0 (none) - 60 (severe) for the overall SES-CD score, with larger scores indicating greater degree of inflammation. Endoscopic response at Week 14 in participants with moderate to severe CD was defined as a reduction in SES-CD of at least 50% from baseline.
| Arm | Type | Description |
|---|---|---|
| TEV-48574, 450 mg (UC) | EXPERIMENTAL | Administered by subcutaneous infusion for participants with UC |
| TEV-48574, 900 mg (UC) | EXPERIMENTAL | Administered by subcutaneous infusion for participants with UC |
| TEV-48574, 1800 mg (UC) | EXPERIMENTAL | Administered by subcutaneous infusion for participants with UC. This arm was discontinued with Amend 03. |
| TEV-48574, 450 mg (CD) | EXPERIMENTAL | Administered by subcutaneous infusion for participants with CD |
| TEV-48574, 900 mg (CD) | EXPERIMENTAL | Administered by subcutaneous infusion for participants with CD |
| TEV-48574, 1800 mg (CD) | EXPERIMENTAL | Administered by subcutaneous infusion for participants with CD. This arm was discontinued with Amend 03. |
| Placebo UC | PLACEBO_COMPARATOR | Matching Placebo |
| Placebo CD | PLACEBO_COMPARATOR | Matching Placebo |
| Name | Type | Description |
|---|---|---|
| TEV-48574 | DRUG | Subcutaneous infusion |
| Placebo | DRUG | Matching Placebo |
Inclusion Criteria: * Diagnosis of Ulcerative Colitis (UC) or Crohn's Disease (CD) for ≥3 months * The participant is able to communicate satisfactorily with the investigator and to participate in, and comply with, the requirements of the study * The participant is able to understand the nature of ...
| 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 |
TEV-48574 is an investigational small molecule being studied for the treatment of moderate to severe Crohn Disease. It is also being evaluated in ulcerative colitis. The drug is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
The molecular target of TEV-48574 has not been disclosed. It is a small molecule therapeutic being developed by Teva Pharmaceutical Industries Limited for gastrointestinal conditions, including Crohn Disease and ulcerative colitis.
TEV-48574 is being developed by Teva Pharmaceutical Industries Limited, a company listed on the stock exchange under the ticker TEVA. The drug is currently in Phase 2 clinical trials for Crohn Disease and ulcerative colitis.
TEV-48574 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA or other regulatory agencies. A Phase 2 trial evaluating the drug in moderate to severe ulcerative colitis or Crohn Disease has been completed.
TEV-48574 has been studied in clinical trial NCT05499130, a Phase 2 study testing the drug in moderate to severe ulcerative colitis or Crohn Disease. This randomized, double-blind, placebo-controlled trial enrolled 290 participants and has been completed.
No alternative names for TEV-48574 have been disclosed. The drug is identified solely by its development code TEV-48574 and is being studied for Crohn Disease and ulcerative colitis.