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Other Disclosures4521KAKEN PHARMACEUTICAL CO.,LTD.Pharmaceuticals

Announcement of Phase III Trial Results for “ESK-001” — Presented at the American Academy of Dermatology Annual Meeting (AAD 2026)

Kaken Pharmaceutical announced that its partner Alumis presented the results of Phase III trials of “ESK-001,” a drug candidate for psoriasis, at the American Academy of Dermatology Annual Meeting. Improvements were observed in skin symptoms, scalp psoriasis, quality of life, and itching in both trials.

Worth reading
70In focus
0–100. This measures how worthwhile something is to read, not how good or bad the company is.
Direction
Improvement
Direction inferred from the company’s description.
Scale
1700
More than [number] people (number of patients enrolled in the trial)
Wording
Conditional
How definitive the wording is.

Announced details

ESK-001envudeucitinib
Applicable field (uses covered by this announcement)

Moderate-to-severe plaque psoriasis and scalp psoriasis. A Phase IIb trial is also underway in systemic lupus erythematosus.

What the company reported numerically
Quantitative Effects

PASI 90 response rate at Week 24: 68.0% for ONWARD1 and 62.1% for ONWARD2. PASI 100 response rate: 41.0% for ONWARD1 and 39.5% for ONWARD2. In patients with scalp psoriasis, approximately 75% achieved an ss-PGA score of 0/1 at Week 24, approximately 50% achieved a DLQI score of 0/1 at Week 12, and the WP NRS improved by an average of more than 4 points from baseline at Week 16.

Usage history

More than 1,700 patients were enrolled in the Phase III ONWARD clinical program (as stated at the time of trial enrollment).

Relationship between the counterparty and the company
KAKEN PHARMACEUTICAL CO.,LTD.4521
Relationship with the Company

A partner from which Kaken Pharmaceutical has obtained the rights to develop, manufacture, and market ESK-001 in the dermatology field in Japan.

CounterpartyAlumis Inc.(Nasdaq:ALMS)

A Nasdaq-listed biotechnology company headquartered in South San Francisco, California, USA. It develops oral therapies for immune-mediated diseases. Its chief executive officer is Martin Babler.

Registration number and expiry date

ONWARD1:NCT06586112、ONWARD2:NCT06588738

Location (as indicated in this announcement)

South San Francisco, California, USA (Alumis headquarters)

In this announcement the company addresses none of Contract Value / Offering price / Impact on Business Performance.

Source (materials cited by the company)

2026 American Academy of Dermatology Annual Meeting (AAD 2026); announcement by Alumis (URL: https://investors.alumis.com/news-events/news-releases)

Announced details
ItemDetails
Names of Products / Services CoveredESK-001, envudeucitinib
CounterpartyAlumis Inc.(Nasdaq:ALMS)
Counterparty overviewA Nasdaq-listed biotechnology company headquartered in South San Francisco, California, USA. It develops oral therapies for immune-mediated diseases. Its chief executive officer is Martin Babler.
Relationship with the CompanyA partner from which Kaken Pharmaceutical has obtained the rights to develop, manufacture, and market ESK-001 in the dermatology field in Japan.
Applicable areaModerate-to-severe plaque psoriasis and scalp psoriasis. A Phase IIb trial is also underway in systemic lupus erythematosus.
Registration number and expiry dateONWARD1:NCT06586112、ONWARD2:NCT06588738
LocationSouth San Francisco, California, USA (Alumis headquarters)
Quantitative EffectsPASI 90 response rate at Week 24: 68.0% for ONWARD1 and 62.1% for ONWARD2. PASI 100 response rate: 41.0% for ONWARD1 and 39.5% for ONWARD2. In patients with scalp psoriasis, approximately 75% achieved an ss-PGA score of 0/1 at Week 24, approximately 50% achieved a DLQI score of 0/1 at Week 12, and the WP NRS improved by an average of more than 4 points from baseline at Week 16.
Usage historyMore than 1,700 patients were enrolled in the Phase III ONWARD clinical program (as stated at the time of trial enrollment).
Source2026 American Academy of Dermatology Annual Meeting (AAD 2026); announcement by Alumis (URL: https://investors.alumis.com/news-events/news-releases)
Items this document does not state (8)
Contract ValueOffering priceContract DateLaunch dateAward/certification nameAwarding / certifying bodyLocation scaleImpact on Business Performance

These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.

The reasons the company gives

The company's own explanation, not something inferred from the numbers.

Because Alumis presented the Phase III trial results at the 2026 American Academy of Dermatology Annual Meeting. The trials evaluated the efficacy and safety of ESK-001.

How to read this page

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Announcement of Phase III Trial Results for “ESK-001” — Presented at the American Academy of Dermatology Annual Meeting (AAD 2026) | KAKEN PHARMACEUTICAL CO.,LTD. (4521) timely disclosure | Komori