Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MEDI2070 · 1 trial · 1 indication
A CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days includes subject reported symptoms, physician-assessed signs, and laboratory markers. CDAI score = Sum of weighted scores for subjective items (number of liquid/soft stools, degree of abdominal pain, general well-being); and objective items (associated signs, use of anti-diarrhoeal medication, abdominal mass, haematocrit, daily morning temperature, body weight). CDAI scores range approximately from 0 to 600, higher scores indicating greater disease activity. The CDAI response at Week 8 is defined as either CDAI score of less than (\<)150 or CDAI reduction from baseline of at least 100 points, where baseline was last non-missing observation prior to first administration of the study drug. Modified Intent-to-treat (mITT)population was analysed for this end point, which included all subjects who were randomized and received at least 1 dose of study drug in double-blind period.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | MEDI2070 iv infusion |
| 2 | PLACEBO_COMPARATOR | placebo iv infusion |
| open-label | EXPERIMENTAL | MEDI2070 sc injection; open-label arm is available for all subjects upon completion of first placebo-controlled treatment period |
| Name | Type | Description |
|---|---|---|
| MEDI2070 | DRUG | 1 iv infusion on Week 0 and Week 4 |
| placebo | DRUG | 1 iv infusion on Week 0 and Week 4 |
Inclusion Criteria: * Diagnosed ileal, ileo-colonic, or colonic CD at least 6 months prior to screening. * Men or women age 18 - 65 years at the time of screening. * Moderate-sever active Crohn's Disease (CD), defined by a Crohn's Disease Activity Index (CDAI) score higher or equal 220 and lower or...
| 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 |
MEDI2070 is an investigational small molecule being studied for the treatment of active, moderate-to-severe Crohn's Disease. It is not approved and remains in clinical development.
The molecular target of MEDI2070 has not been disclosed. It is a small molecule, but its specific mechanism of action is not publicly detailed.
MEDI2070 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN.
MEDI2070 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities.
MEDI2070 has one completed Phase 2 trial, NCT01714726, which evaluated its efficacy and safety in 121 patients with active, moderate-to-severe Crohn's Disease. The trial was randomized, double-blind, and placebo-controlled.