Alumis Presents Additional Phase 1 Data at ACTRIMS Forum 2025 Supporting Potential of A-005 as First-in-Class CNS Penetrant TYK2 Inhibitor for Treatment of Neuroinflammatory and Neurodegenerative Diseases
Alumis (Nasdaq: ALMS) announced new Phase 1 data presentations for A-005, their first-in-class CNS penetrant TYK2 inhibitor, at the ACTRIMS Forum 2025. A-005 demonstrated potent inhibition of TYK2-specific signaling in immune cells and CNS resident cells, with the ability to cross the blood-brain barrier.
The Phase 1 clinical trials showed that A-005 was well-tolerated and achieved maximal TYK2 inhibition across various doses. The company plans to advance to Phase 2 clinical trials for multiple sclerosis patients in the second half of 2025.
Two presentations are scheduled for February 28, 2025: one focusing on A-005's effects on astrocytes and microglia (Poster P352), and another discussing safety, tolerability, and pharmacokinetics in healthy volunteers (Poster P335).
Alumis (Nasdaq: ALMS) ha annunciato nuove presentazioni dei dati della Fase 1 per A-005, il loro inibitore TYK2 di prima classe in grado di penetrare nel sistema nervoso centrale, durante il Forum ACTRIMS 2025. A-005 ha dimostrato una potente inibizione della segnalazione specifica di TYK2 nelle cellule immunitarie e nelle cellule residenti del sistema nervoso centrale, con la capacità di attraversare la barriera emato-encefalica.
Le sperimentazioni cliniche di Fase 1 hanno mostrato che A-005 è stato ben tollerato e ha raggiunto un'inibizione massimale di TYK2 a diverse dosi. L'azienda prevede di avanzare alla Fase 2 delle sperimentazioni cliniche per i pazienti affetti da sclerosi multipla nella seconda metà del 2025.
Due presentazioni sono programmate per il 28 febbraio 2025: una incentrata sugli effetti di A-005 su astrociti e microglia (Poster P352) e l'altra che discute sicurezza, tollerabilità e farmacocinetica in volontari sani (Poster P335).
Alumis (Nasdaq: ALMS) anunció nuevas presentaciones de datos de la Fase 1 para A-005, su inhibidor de TYK2 de primera clase que penetra en el sistema nervioso central, en el Foro ACTRIMS 2025. A-005 demostró una potente inhibición de la señalización específica de TYK2 en células inmunitarias y células residentes del sistema nervioso central, con la capacidad de cruzar la barrera hematoencefálica.
Los ensayos clínicos de la Fase 1 mostraron que A-005 fue bien tolerado y logró una inhibición máxima de TYK2 en varias dosis. La empresa planea avanzar a la Fase 2 de ensayos clínicos para pacientes con esclerosis múltiple en la segunda mitad de 2025.
Se programaron dos presentaciones para el 28 de febrero de 2025: una centrada en los efectos de A-005 en astrocitos y microglía (Póster P352), y otra que discute seguridad, tolerabilidad y farmacocinética en voluntarios sanos (Póster P335).
Alumis (Nasdaq: ALMS)는 ACTRIMS 포럼 2025에서 첫 번째 클래스의 CNS 침투 TYK2 억제제인 A-005에 대한 새로운 1상 데이터 발표를 발표했습니다. A-005는 면역 세포와 CNS 거주 세포에서 TYK2 특정 신호 전달을 강력하게 억제하며, 혈액-뇌 장벽을 통과할 수 있는 능력을 보여주었습니다.
1상 임상 시험 결과 A-005는 잘 견딜 수 있었고 다양한 용량에서 최대 TYK2 억제를 달성했습니다. 회사는 2025년 하반기에 다발성 경화증 환자를 위한 2상 임상 시험으로 나아갈 계획입니다.
2025년 2월 28일에 두 가지 발표가 예정되어 있습니다: 하나는 A-005의 별아교세포 및 미세아교세포에 대한 효과에 초점을 맞춘 것(포스터 P352)이고, 다른 하나는 건강한 자원봉사자에 대한 안전성, 내약성 및 약동학을 논의하는 것입니다(포스터 P335).
Alumis (Nasdaq: ALMS) a annoncé de nouvelles présentations de données de Phase 1 pour A-005, leur inhibiteur TYK2 de première classe capable de pénétrer le système nerveux central, lors du Forum ACTRIMS 2025. A-005 a démontré une inhibition puissante de la signalisation spécifique de TYK2 dans les cellules immunitaires et les cellules résidentes du système nerveux central, avec la capacité de traverser la barrière hémato-encéphalique.
Les essais cliniques de Phase 1 ont montré que A-005 était bien toléré et atteignait une inhibition maximale de TYK2 à différentes doses. L'entreprise prévoit de passer aux essais cliniques de Phase 2 pour les patients atteints de sclérose en plaques dans la seconde moitié de 2025.
Deux présentations sont prévues pour le 28 février 2025 : l'une axée sur les effets de A-005 sur les astrocytes et les microglies (Affiche P352), et l'autre discutant de la sécurité, de la tolérabilité et de la pharmacocinétique chez des volontaires en bonne santé (Affiche P335).
Alumis (Nasdaq: ALMS) hat neue Präsentationen von Phase-1-Daten für A-005, ihren erstklassigen TYK2-Hemmer, der in das zentrale Nervensystem eindringen kann, auf dem ACTRIMS-Forum 2025 angekündigt. A-005 zeigte eine starke Hemmung der TYK2-spezifischen Signalübertragung in Immunzellen und Zellen des zentralen Nervensystems, mit der Fähigkeit, die Blut-Hirn-Schranke zu überwinden.
Die klinischen Phase-1-Studien zeigten, dass A-005 gut vertragen wurde und eine maximale TYK2-Hemmung über verschiedene Dosen hinweg erreichte. Das Unternehmen plant, in der zweiten Hälfte des Jahres 2025 zu Phase-2-Klinischen Studien für Patienten mit Multipler Sklerose überzugehen.
Zwei Präsentationen sind für den 28. Februar 2025 geplant: eine, die sich auf die Auswirkungen von A-005 auf Astrozyten und Mikroglia konzentriert (Poster P352), und eine andere, die Sicherheit, Verträglichkeit und Pharmakokinetik bei gesunden Freiwilligen behandelt (Poster P335).
- First-in-class CNS penetrant TYK2 inhibitor with blood-brain barrier crossing ability
- Successful Phase 1 results showing maximum TYK2 inhibition
- Well-tolerated safety profile across broad dose range
- Advancing to Phase 2 trials in multiple sclerosis
- Early-stage development - still in Phase 1
- Efficacy in multiple sclerosis patients not yet demonstrated
Insights
Alumis's presentation of Phase 1 data for A-005 represents a potentially significant advancement in neuroinflammatory disease treatment. As the first allosteric TYK2 inhibitor with demonstrated blood-brain barrier penetration, A-005 addresses a critical limitation of current immunomodulatory therapies that often fail to effectively target CNS inflammation.
The data showing A-005 inhibits TYK2 signaling in both peripheral immune cells and CNS resident cells (astrocytes and microglia) is particularly noteworthy. This dual-action mechanism could provide more comprehensive control of neuroinflammation than existing treatments that primarily target peripheral immune responses. The favorable safety profile and achievement of maximal TYK2 inhibition across multiple doses suggests potential for flexible dosing in future studies.
For multiple sclerosis—a market valued at approximately
Alumis's planned advancement to Phase 2 trials in the second half of 2025 indicates confidence in A-005's potential, though investors should recognize that success in Phase 1 primarily demonstrates safety rather than efficacy. The company's precision medicine approach to immune-mediated diseases positions this candidate as potentially applicable beyond MS to other neuroinflammatory and neurodegenerative conditions, which could significantly expand its market potential if successful in later-stage trials.
SOUTH SAN FRANCISCO, Calif., Feb. 27, 2025 (GLOBE NEWSWIRE) -- Alumis Inc. (Nasdaq: ALMS) (“Alumis” or the “Company”), a clinical stage biopharmaceutical company developing oral therapies using a precision approach to optimize clinical outcomes and significantly improve the lives of patients with immune-mediated diseases, today announced the Company will give two data presentations on A-005, a potent, selective, central nervous system (CNS) penetrant tyrosine kinase 2 (TYK2) inhibitor, on Friday, February 28, 2025, at the 10th Annual Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2025.
“These data demonstrate that A-005 potently inhibits TYK2-specific signaling in immune cells and CNS resident cells, targeting pro-inflammatory cytokine pathways implicated in the pathology of neuroinflammatory diseases,” said Jörn Drappa, M.D., Alumis’ Chief Medical Officer. “As the first reported allosteric TYK2 inhibitor with demonstrated ability to cross the blood-brain barrier, A-005 represents a novel approach to potentially treating a broad range of diseases associated with CNS inflammation.”
Dr. Drappa added, “The Phase 1 clinical data demonstrate that A-005 was well tolerated and achieved maximal TYK2 inhibition across a broad dose range. These data support our plans to commence a Phase 2 clinical trial in patients with multiple sclerosis in the second half of this year.”
Details regarding the February 28, 2025, presentations are as follows:
Title: A-005, a Selective Oral Brain Penetrant TYK2 Inhibitor, Modulates Astrocytes and Microglia
Poster Number: P352
Time: 6:00 PM – 6:45 PM ET
Title: Safety, Tolerability, and Pharmacokinetics of A-005: A Selective Brain-Penetrant TYK2 Inhibitor for CNS Inflammatory Diseases in Healthy Volunteers Following Single and Multiple Ascending Doses
Poster Number: P335
Time: 6:45 PM – 7:30 PM ET
The ACTRIMS Forum 2025 posters will be made available in the Publications section of the Alumis website on February 28, 2025 concurrent with the presentations.
About the A-005 Phase 1 Clinical Trial
The Phase 1 clinical trial evaluated the safety, tolerability, and pharmacokinetics (PK) of single- and multiple-ascending doses of A-005 in 135 healthy participants. The trial included a single-ascending dose (SAD) portion which evaluated ten dose cohorts, a 14-day multiple-ascending (MAD) dose portion which evaluated five dose cohorts (n=8, 6 active, 2 placebo) and a single dose cohort which included a lumbar puncture to assess A-005 concentrations in the CSF. For the SAD and MAD portions of the study, pharmacodynamic (PD) markers (including pSTAT levels) were measured to establish a PK/PD relationship.
About A-005
A-005 is a potential first-in-class CNS-penetrant allosteric TYK2 inhibitor being developed for the treatment of neuroinflammatory and neurodegenerative diseases such as multiple sclerosis and Parkinson’s Disease. A-005 is designed to achieve maximal TYK2 inhibition and to cross the blood brain barrier for localized treatment both within the CNS and in the periphery, supporting its potential across multiple TYK2-mediated indications. TYK2 is a protein that plays a role in mediating signaling responses to key proinflammatory cytokines, including interleukin (IL)-23 and type 1 interferon. A-005 completed a Phase 1 clinical trial in healthy participants and is expected to enter a Phase 2 clinical trial in patients with multiple sclerosis in the second half of 2025.
About Alumis
Alumis is a clinical stage biopharmaceutical company developing oral therapies using a precision approach to optimize clinical outcomes and significantly improve the lives of patients with immune-mediated diseases. Leveraging its proprietary precision data analytics platform, Alumis is building a pipeline of molecules with the potential to address a broad range of immune-mediated diseases as monotherapy or combination therapies. Alumis’ most advanced product candidate, ESK-001, is an oral, highly selective, small molecule, allosteric inhibitor of TYK2 that is currently being evaluated for the treatment of patients with moderate-to-severe plaque psoriasis and systemic lupus erythematosus. Alumis is also developing A-005, a clinical-stage, CNS-penetrant, allosteric TYK2 inhibitor for the treatment of neuroinflammatory and neurodegenerative diseases. Beyond TYK2, Alumis’ proprietary precision data analytics platform and drug discovery expertise have led to the identification of additional preclinical programs that exemplify its precision approach. Incubated by Foresite Labs and led by a team of industry veterans experienced in small-molecule compound drug development for immune-mediated diseases, Alumis is pioneering a precision approach to drug development to potentially produce the next generation of treatment to address immune dysfunction. For more information, visit www.alumis.com.
Forward-Looking Statements
This press release contains forward-looking statements, including statements made pursuant to 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. Any such statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements. These forward-looking statements include, without limitation, statements regarding Alumis’ future plans and prospects including development and commercialization of its pipeline, the timing and initiation of Alumis’ planned Phase 2 clinical trial in MS, any expectations regarding the safety, efficacy or tolerability of A-005, the potential of ESK-001 to treat moderate-to-severe plaque psoriasis and systemic lupus erythematosus, and the potential of A-005 to be a first-in-class treatment for neurodegenerative diseases, including a broad range of diseases associated with CNS inflammation. 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 A-005 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.
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