Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ATI-450 · 3 trials · 2 indications
AN count was the sum of number of abscess and inflammatory nodules across anatomical regions. The least square (LS) mean change from baseline in the count at Week 12 was estimated from the Mixed Model Repeated Measures (MMRM) model.
Safety and tolerability reported as Adverse Events (AEs). AEs will be coded with the Medical Dictionary for Regulatory Activities (MedDRA) version 23.0. AEs will be presented by system organ class and preferred term in frequency tables.
| Arm | Type | Description |
|---|---|---|
| ATI-450 20 mg BID plus Methotrexate | EXPERIMENTAL | ATI-450 20 mg oral tablet twice daily (BID) with a stable weekly dose of methotrexate for 12 weeks |
| ATI-450 50 mg BID plus Methotrexate | EXPERIMENTAL | ATI-450 50 mg oral tablet BID with a stable weekly dose of methotrexate for 12 weeks |
| Placebo plus Methotrexate | PLACEBO_COMPARATOR | Placebo oral tablet BID with a stable weekly dose of methotrexate for 12 weeks |
| ATI-450 | EXPERIMENTAL | ATI-450 50 milligrams (mg) oral tablet twice daily (BID) |
| Placebo | EXPERIMENTAL | Placebo oral tablet BID |
| ATI-450 plus Methotrexate | EXPERIMENTAL | ATI-450 50mg oral tablet BID with a stable weekly dose of Methotrexate |
| Name | Type | Description |
|---|---|---|
| ATI-450 50 mg oral tablet BID | DRUG | Oral, small molecule MK2 inhibitor |
| Placebo oral tablet | DRUG | Placebo tablet manufactured to match ATI-450 in appearance |
| Methotrexate | DRUG | 15 mg to 25 mg weekly |
| ATI-450 20 mg oral tablet BID | DRUG | Oral, small molecule MK2 inhibitor |
| ATI-450 | DRUG | Oral, small molecule MK2 inhibitor |
Inclusion Criteria: * Able to comprehend and be willing to sign the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved participant ICF prior to administration of any study-related procedures. * Diagnosis of adult-onset RA as defined by the 2010 American College of Rheumato...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AbbVie, Inc. | ABBV | 5 | PHASE3 | Upadacitinib |
| Incyte Corporation | INCY | 6 | PHASE3 | Povorcitinib |
| Novartis AG Sponsored ADR | NVS | 11 | PHASE3 | Remibrutinib Dose A, Remibrutinib Dose B |
| MoonLake Immunotherapeutics Class A | MLTX | 2 | PHASE3 | Sonelokimab |
| Sanofi SA Sponsored ADR | SNY | 2 | PHASE2 | Brivekimig |
| Pfizer Inc. | PFE | 1 | PHASE2 | Ritlecitinib |
| Merck & Co., Inc. | MRK | 1 | PHASE2 | Tulisokibart |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 1 | PHASE2 | Zasocitinib |
| Zura Bio Limited Class A | ZURA | 1 | PHASE2 | Tibulizumab Dose A, Tibulizumab Dose B |
| Sonoma Pharmaceuticals, Inc. | SNOA | 2 | PHASE1 | SBT777101 |
| Evommune, Inc. | EVMN | 1 | EARLY_PHASE1 | EVO101 |
ATI-450 is an investigational small molecule being studied for the treatment of hidradenitis suppurativa and rheumatoid arthritis. It is currently in Phase 2 clinical development and has not been approved by the FDA.
ATI-450 is being developed by Aclaris Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ACRS.
ATI-450 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. Clinical trials have been completed for both hidradenitis suppurativa and rheumatoid arthritis.
ATI-450 has been studied in three completed Phase 2 trials: NCT04247815 and NCT05279417 for rheumatoid arthritis, and NCT05216224 for hidradenitis suppurativa. These trials were randomized, double-blind, and controlled, with a total enrollment of 276 participants.
No alternative names for ATI-450 have been reported. It is referred to solely as ATI-450 in clinical trial records and by its developer, Aclaris Therapeutics.