Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ATI-501 · 1 trial · 1 indication
The Severity of Alopecia Tool (SALT) score is a physician administered scale measuring the amount of scalp without any terminal hair assessed by the investigator. Possible scores range from 0 (no scalp hair loss) to 100 (complete scalp hair loss). A negative change in the SALT score over time represents hair regrowth by adding the percentage hair loss in the various areas (i.e. top, back, each side) of the scalp. The primary efficacy variable was the percent change from baseline in SALT score at Week 24. This was calculated as the mean of the changes from Baseline (Visit 2) SALT score to Week 24 (Visit 10) SALT score, divided by Baseline SALT score and expressed as a percentage.
| Arm | Type | Description |
|---|---|---|
| 400mg BID (Low dose) | ACTIVE_COMPARATOR | ATI-501 low dose - oral administration |
| 600mg BID (Mid dose) | ACTIVE_COMPARATOR | ATI-501 mid dose - oral administration |
| 800mg BID (High dose) | ACTIVE_COMPARATOR | ATI-501 high dose - oral administration |
| Placebo | PLACEBO_COMPARATOR | Placebo - oral administration |
| Name | Type | Description |
|---|---|---|
| ATI-501 400mg BID (Low dose) | DRUG | ATI-501 400mg BID oral low dose for oral administration |
| ATI-501 600mg BID (Mid dose) | DRUG | ATI-501 600mg BID oral mid dose for oral administration |
| ATI-501 800mg BID (High dose) | DRUG | ATI-501 800mg BID high dose for oral administration |
| Placebo | DRUG | Placebo - oral administration |
Inclusion Criteria: Subjects must meet the following criteria to be eligible for participation in the study: 1. Able to comprehend and willing to sign an Informed Consent Form (ICF). 2. Male or non-pregnant, non-nursing female ≥ 18 years old at the time of informed consent. 3. Have a clinical diag...
Top 9 of 12 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Pfizer Inc. | PFE | 8 | PHASE3 | Ritlecitinib |
| AbbVie, Inc. | ABBV | 4 | PHASE3 | Upadacitinib |
| Veradermics, Incorporated | MANE | 4 | PHASE3 | VDPHL01 |
| Eli Lilly and Company | LLY | 2 | PHASE3 | Baricitinib, LY4005130 |
| Q32 Bio Inc | QTTB | 1 | PHASE2 | Bempikibart |
| Forte Biosciences Inc. | FBRX | 1 | PHASE1 | FB102 |
| Absci Corporation | ABSI | 1 | PHASE1 | ABS-201 |
| HCW Biologics, Inc. | HCWB | 1 | PHASE1 | HCW9302 |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE2 | dupilumab |
ATI-501 is an investigational small molecule being studied for alopecia, including alopecia areata, alopecia universalis, and alopecia totalis. It was evaluated as an oral suspension in a Phase 2 clinical trial in adults. It is not an approved treatment and remains in clinical development.
ATI-501 is developed by Aclaris Therapeutics, Inc., which trades on the Nasdaq under the ticker ACRS. The company sponsored the Phase 2 study of the drug in alopecia areata, alopecia universalis, and alopecia totalis.
ATI-501 is in Phase 2 development. One Phase 2 trial has been completed, and no trials are currently active. The drug is investigational and has not been approved by the FDA for any indication.
ATI-501 was studied in the Phase 2 trial NCT03594227, titled ATI-501 Oral Suspension Compared to Placebo in Subjects With Alopecia Areata, Alopecia Universalis or Alopecia Totalis. The completed trial enrolled 87 participants in the United States, was randomized, double blind, and placebo controlled, and included adults 18 years and older.