Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ESK-001 · 2 trials · 2 indications
Proportion of patients with moderate to severe psoriasis achieving ≥75% reduction in PASI score
| Arm | Type | Description |
|---|---|---|
| ESK-001 Dose Level 1 | EXPERIMENTAL | ESK-001 administered as an oral tablet |
| ESK-001 Dose Level 2 | EXPERIMENTAL | ESK-001 administered as an oral tablet |
| ESK-001 Dose Level 3 | EXPERIMENTAL | ESK-001 administered as an oral tablet |
| ESK-001 Dose Level 4 | EXPERIMENTAL | ESK-001 administered as an oral tablet |
| ESK-001 Dose Level 5 | EXPERIMENTAL | ESK-001 administered as an oral tablet |
| Placebo | PLACEBO_COMPARATOR | Placebo administered as an oral tablet |
| Healthy Volunteer | EXPERIMENTAL | Up to 24 healthy volunteer participants will receive a single dose of ESK-001 |
| Mild Renal Impairment | EXPERIMENTAL | 8 participants with mild renal impairment will receive a single dose of ESK-001 |
| Moderate Renal Impairment | EXPERIMENTAL | 8 participants with moderate renal impairment will receive a single dose of ESK-001 |
| Severe Renal Impairment | EXPERIMENTAL | 8 participants with severe Renal impairment will receive a single dose of ESK-001 |
| Name | Type | Description |
|---|---|---|
| ESK-001 | DRUG | Oral tablet |
| Placebo | DRUG | Oral tablet |
Inclusion Criteria: * Total body weight \>40 kg (88 lb) * Men and woman age 18-75 * Men and Women must use highly effective methods of contraception for the entirety of the study Exclusion Criteria: * History of malignancy within the last 5 years * Positive for HIV, Hepatitis B or C * History of ...
ESK-001 is an investigational oral small molecule being developed by Alumis Inc. for plaque psoriasis, a chronic inflammatory skin condition. It is also being studied in people with impaired kidney function. It is not approved for any indication and remains in clinical development.
ESK-001 targets TYK2, a tyrosine kinase involved in inflammatory signaling. By inhibiting TYK2, the drug is designed to dampen the immune pathways that drive plaque psoriasis. TYK2 inhibition is the mechanism underlying ESK-001's development in immune-mediated disease.
ESK-001 is being developed by Alumis Inc., a biopharmaceutical company that trades on the Nasdaq under the ticker ALMS. Alumis is the sponsor of the clinical program evaluating ESK-001 in plaque psoriasis and in patients with renal impairment.
ESK-001 is in Phase 2 development for plaque psoriasis, with a completed Phase 2 trial in that indication. A separate Phase 1 trial in renal impairment has also been completed. ESK-001 is investigational and has not been approved by the FDA for any use.
ESK-001 has been studied in two completed trials. NCT05600036 was a Phase 2, randomized, double-blind, placebo-controlled study of ESK-001 in 228 patients with plaque psoriasis across the United States, Canada, and Czechia. NCT06962774 was a Phase 1 study of ESK-001 in 16 participants with normal and impaired renal function in the United States.