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...
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| Eli Lilly and Company | LLY | 2 | PHASE3 | Baricitinib |
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| Forte Biosciences Inc. | FBRX | 1 | PHASE1 | FB102 |
| Absci Corporation | ABSI | 1 | PHASE1 | ABS-201 Single Dose, ABS-201 Multiple Doses |
| HCW Biologics, Inc. | HCWB | 1 | PHASE1 | HCW9302, an IL-2 fusion protein |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE2 | Dupilumab |
ATI-501 is an investigational oral suspension being studied for the treatment of alopecia, specifically alopecia areata, alopecia universalis, and alopecia totalis. It is a small molecule developed by Aclaris Therapeutics for dermatology indications.
ATI-501 is a small molecule, but its specific molecular target has not been disclosed. It is being investigated for its effects on alopecia areata, alopecia universalis, and alopecia totalis, though the exact mechanism of action is not publicly detailed.
ATI-501 is being developed by Aclaris Therapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol ACRS. The company is conducting clinical research on this oral suspension for alopecia.
ATI-501 is in Phase 2 clinical development. It has completed a Phase 2 trial, and it remains an investigational drug that has not been approved by regulatory authorities. Its safety and efficacy are still being evaluated.
ATI-501 has one completed Phase 2 clinical trial, identified as NCT03594227. This study compared ATI-501 oral suspension to placebo in subjects with alopecia areata, alopecia universalis, or alopecia totalis. The trial enrolled 87 participants in the United States.
No alternative names for ATI-501 have been disclosed. It is referred to solely as ATI-501 in clinical trial records and by its developer, Aclaris Therapeutics.