Alumis Completes Patient Enrollment in the Global LUMUS Phase 2b Trial of ESK-001, a Next-Generation Oral TYK2 Inhibitor for the Treatment of Systemic Lupus Erythematosus
Alumis (Nasdaq: ALMS) has completed patient enrollment in its global LUMUS Phase 2b trial for ESK-001, a next-generation oral TYK2 inhibitor targeting systemic lupus erythematosus (SLE). The trial has enrolled 408 patients who will receive ESK-001 or placebo for 48 weeks.
The study will evaluate the drug's efficacy in treating moderately-to-severely active, autoantibody-positive SLE, with topline data expected in Q3 2026. The primary endpoint will measure disease activity improvements using the BICLA assessment at Week 48. The company reports that ESK-001 has shown promising results in their psoriasis program, demonstrating full target inhibition and general tolerability.
Alumis (Nasdaq: ALMS) ha completato il reclutamento dei pazienti per il suo studio globale LUMUS di Fase 2b su ESK-001, un inibitore orale di nuova generazione di TYK2 destinato al trattamento del lupus eritematoso sistemico (LES). Lo studio ha arruolato 408 pazienti che riceveranno ESK-001 o placebo per un periodo di 48 settimane.
Lo studio valuterà l'efficacia del farmaco nel trattamento del LES moderatamente-severo, con positività agli autoanticorpi, e i dati principali sono attesi per il terzo trimestre del 2026. L'endpoint primario misurerà i miglioramenti dell'attività della malattia utilizzando la valutazione BICLA alla settimana 48. L'azienda riferisce che ESK-001 ha mostrato risultati promettenti nel programma per la psoriasi, dimostrando un'inibizione completa del target e una buona tollerabilità generale.
Alumis (Nasdaq: ALMS) ha finalizado la incorporación de pacientes en su ensayo global LUMUS de fase 2b para ESK-001, un inhibidor oral de TYK2 de próxima generación dirigido al lupus eritematoso sistémico (LES). El ensayo ha reclutado a 408 pacientes que recibirán ESK-001 o placebo durante 48 semanas.
El estudio evaluará la eficacia del medicamento en el tratamiento del LES moderadamente a severamente activo, positivo para autoanticuerpos, y se esperan datos principales para el tercer trimestre de 2026. El criterio principal medirá las mejoras en la actividad de la enfermedad utilizando la evaluación BICLA en la semana 48. La compañía informa que ESK-001 ha mostrado resultados prometedores en su programa para psoriasis, demostrando una inhibición completa del objetivo y buena tolerabilidad general.
Alumis (나스닥: ALMS)는 전신 홍반성 루푸스(SLE)를 표적으로 하는 차세대 경구 TYK2 억제제인 ESK-001의 글로벌 LUMUS 2b상 임상시험 환자 등록을 완료했습니다. 이번 임상시험에는 408명의 환자가 등록되었으며, 이들은 48주 동안 ESK-001 또는 위약을 투여받게 됩니다.
본 연구는 중등도에서 중증의 자가항체 양성 SLE 치료에 대한 약물의 효능을 평가할 예정이며, 주요 결과 데이터는 2026년 3분기에 발표될 예정입니다. 주요 평가 지표는 48주차에 BICLA 평가를 통해 질병 활동성 개선을 측정합니다. 회사는 ESK-001이 건선 프로그램에서 완전한 표적 억제와 전반적인 내약성을 입증하며 유망한 결과를 보였다고 보고했습니다.
Alumis (Nasdaq : ALMS) a terminé le recrutement des patients dans son essai mondial LUMUS de phase 2b pour ESK-001, un inhibiteur oral TYK2 de nouvelle génération ciblant le lupus érythémateux systémique (LES). L'essai a inclus 408 patients qui recevront ESK-001 ou un placebo pendant 48 semaines.
L'étude évaluera l'efficacité du médicament dans le traitement du LES modérément à sévèrement actif, auto-anticorps positif, avec des données principales attendues au 3e trimestre 2026. Le critère principal mesurera l'amélioration de l'activité de la maladie via l'évaluation BICLA à la semaine 48. La société rapporte que ESK-001 a montré des résultats prometteurs dans leur programme sur le psoriasis, démontrant une inhibition complète de la cible et une bonne tolérance générale.
Alumis (Nasdaq: ALMS) hat die Patienteneinschreibung für seine globale LUMUS Phase-2b-Studie zu ESK-001, einem oralen TYK2-Inhibitor der nächsten Generation zur Behandlung des systemischen Lupus erythematodes (SLE), abgeschlossen. Die Studie hat 408 Patienten eingeschlossen, die für 48 Wochen entweder ESK-001 oder ein Placebo erhalten.
Die Studie wird die Wirksamkeit des Medikaments bei mittelschwer bis schwer aktiver, autoantikörperpositiver SLE bewerten, wobei die wichtigsten Ergebnisse im 3. Quartal 2026 erwartet werden. Der primäre Endpunkt misst Verbesserungen der Krankheitsaktivität anhand der BICLA-Bewertung in Woche 48. Das Unternehmen berichtet, dass ESK-001 in ihrem Psoriasis-Programm vielversprechende Ergebnisse gezeigt hat, mit vollständiger Zielhemmung und guter Verträglichkeit.
- None.
- Long wait for trial results (Q3 2026)
- Still in Phase 2b, requiring additional studies before potential approval
- Faces competition in crowded lupus treatment market
Insights
Alumis completes enrollment in Phase 2b lupus trial; topline data expected Q3 2026 represents key milestone for potential new oral treatment option.
Alumis has reached a significant development milestone with the completion of patient enrollment in their LUMUS Phase 2b trial for ESK-001, their oral TYK2 inhibitor for systemic lupus erythematosus (SLE). The trial has successfully enrolled 408 patients globally, positioning the company for a topline data readout in Q3 2026.
This enrollment completion is particularly notable in the SLE space, where patient recruitment can be challenging due to the complex nature of the disease. The 48-week treatment duration suggests the company is conducting a robust evaluation of both efficacy and safety signals, essential for autoimmune conditions requiring chronic therapy.
The trial's primary endpoint using the BICLA assessment at Week 48 is an established and regulatory-acceptable measure of disease improvement in lupus trials. This choice of endpoint aligns with successful SLE development programs and demonstrates the company's strategic approach to clinical development.
What's technically differentiated about ESK-001 is its selective targeting of TYK2, a key mediator in type 1 interferon signaling that plays a central role in SLE pathogenesis. Unlike less selective JAK inhibitors, ESK-001's design aims to minimize off-target effects while maximizing therapeutic impact - addressing a critical balance in lupus treatment where safety concerns have historically limited therapeutic options.
The reference to positive clinical data from their psoriasis program suggests cross-indication validation of the mechanism, though the immunological pathways in psoriasis and SLE differ significantly. If successful, ESK-001 would represent a meaningful addition to the limited oral therapy options for lupus patients, potentially offering biologic-like efficacy in a more convenient formulation.
-Topline Readout Expected in Q3 2026-
SOUTH SAN FRANCISCO, Calif., July 24, 2025 (GLOBE NEWSWIRE) -- Alumis Inc. (Nasdaq: ALMS), a late-stage biopharma company developing next-generation targeted therapies for patients with immune-mediated diseases, today announced the completion of patient enrollment in its global LUMUS Phase 2b trial of ESK-001, a highly selective, next-generation oral tyrosine kinase 2 (TYK2) inhibitor, for the treatment of systemic lupus erythematosus (SLE), the most common form of lupus.
“Completion of enrollment in our global LUMUS Phase 2b trial for SLE marks a significant milestone for Alumis, and importantly, for the lupus community,” said Martin Babler, President and Chief Executive Officer of Alumis. “This achievement reflects the dedication of our clinical partners, investigators, patients, and the entire Alumis team, positioning us to share topline data in the third quarter of 2026.”
“People living with SLE face a heavy burden and few treatment options,” added Dr. Jörn Drappa, Alumis’ Chief Medical Officer. “ESK-001, our next-generation oral TYK2 inhibitor, is designed to change that—selectively targeting key inflammatory drivers like type 1 IFN to maximize inhibition while minimizing off-target binding and effects. Clinical data in our psoriasis program has demonstrated that ESK-001 achieved full, sustained target inhibition and was generally well tolerated, positioning it as a promising oral therapy with potential for biologic-like clinical responses.”
The global LUMUS Phase 2b trial is a randomized, double-blind, placebo-controlled study evaluating multiple doses of ESK-001 in adults with moderately-to-severely active, autoantibody-positive SLE. The trial enrolled 408 patients who are receiving ESK-001 or placebo for 48 weeks. The primary endpoint will be to assess improvements in overall disease activity using the British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) at Week 48. After the trial, eligible patients may participate in an open-label extension or complete a four-week safety follow-up.
About ESK-001
ESK-001 is a highly selective, next-generation oral TYK2 inhibitor designed to correct immune dysregulation across a range of diseases, including SLE, the most common form of lupus. By selectively targeting key proinflammatory mediators, including type 1 interferon (IFN), it aims to deliver maximal inhibition while minimizing off-target effects.
Clinical data in Alumis’ psoriasis program indicates that ESK-001 downregulates key cytokines and disease biomarkers relative to SLE, disrupting pro-inflammatory pathways which Alumis believes may have the potential to reduce SLE disease activity. In Phase 1 studies, it demonstrated full, sustained target inhibition and was well tolerated in healthy volunteers. These data, along with ESK-001’s ability to achieve maximal TYK2 inhibition in patients with psoriasis, suggest it could become a potential oral treatment with biologic-like clinical response rates for SLE.
The global LUMUS Phase 2b trial (NCT05966480) is evaluating multiple doses of ESK-001 in adults with moderately-to-severely active, autoantibody-positive SLE. The randomized, double-blind, placebo-controlled study enrolled 408 patients, with topline data expected in the third quarter of 2026.
The efficacy and safety of ESK-001 in adult patients with moderate-to-severe plaque psoriasis is currently being evaluated in the Phase 3 ONWARD clinical program. Alumis continues to leverage its precision data analytics platform to explore ESK-001’s potential applications in other immune-mediated conditions.
About Alumis
Alumis is a late-stage biopharma company developing next-generation targeted therapies with the potential to significantly improve patient health and outcomes across a range of immune-mediated diseases. Leveraging its proprietary data analytics platform and precision approach, Alumis is developing a pipeline of oral tyrosine kinase 2 inhibitors, consisting of ESK-001 for the treatment of systemic immune-mediated disorders, such as moderate-to-severe plaque psoriasis and systemic lupus erythematosus, and A-005 for the treatment of neuroinflammatory and neurodegenerative diseases. In addition, the pipeline includes lonigutamab, a subcutaneously delivered anti–insulin-like growth factor 1 receptor therapy for the treatment of thyroid eye disease, as well as several preclinical programs identified through this precision approach. For more information, visit www.alumis.com or follow us on LinkedIn or X.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of federal securities laws, including the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will" and variations of these words or similar expressions that are intended to identify forward-looking statements. All statements, other than statements of historical facts, including without limitation those regarding the timing of Alumis’ topline readout in its LUMUS Phase 2b program, the potential for ESK-001 to treat moderate-to-severe plaque psoriasis and systemic lupus erythematosus, any expectations regarding the safety, efficacy or tolerability of ESK-001 and statements regarding Alumis’ future plans and prospects, including development of its clinical pipeline; and any assumptions underlying any of the foregoing, are forward-looking statements. Any forward-looking statements in this press release are based on Alumis’ current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Readers are cautioned that actual results, levels of activity, safety, efficacy, performance or events and circumstances could differ materially from those expressed or implied in Alumis’ forward-looking statements due to a variety of risks and uncertainties, which include, without limitation, risks and uncertainties related to Alumis’ ability to advance ESK-001 and to obtain regulatory approval of and ultimately commercialize Alumis’ clinical candidates, the timing and results of preclinical and clinical trials, Alumis’ ability to fund development activities and achieve development goals, Alumis’ ability to protect its intellectual property and other risks and uncertainties described in Alumis’ filings with the Securities and Exchange Commission (SEC), including any future reports Alumis may file with the SEC from time to time. Alumis explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.
Alumis Contact Information Teri Dahlman Red House Communications teri@redhousecomms.com
FAQ
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