envudeucitinib (ESK-001) / Alumis - LARVOL DELTA

Treat-to-Target Outcomes With ESK-001 in Moderate-to-Severe Plaque Psoriasis: Results From the Phase 2 STRIDE & Open-Label Extension Studies (ESDR 2025) - No abstract available

Clinical • P2 data • Dermatology • Immunology • Psoriasis

Envudeucitinib designated generic name for ESK-001 (GlobeNewswire)

Commercial • Immunology • Psoriasis • Systemic Lupus Erythematosus

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 (GlobeNewswire) - "Alumis...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....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....Topline readout expected in Q3 2026."

Enrollment closed • P2b data • Systemic Lupus Erythematosus

LUMUS: Phase 2 Placebo-Controlled Study to Assess the Safety and Efficacy of ESK-001 in Active Systemic Lupus Erythematosus (clinicaltrials.gov) - P2 | N=408 | Active, not recruiting | Sponsor: Alumis Inc | Recruiting ➔ Active, not recruiting

Enrollment closed • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Highly selective, allosteric inhibition of TYK2 with oral ESK-001 in patients with moderate-to-severe plaque psoriasis: Results from STRIDE, a 12-week, randomized, double-blinded, placebo-controlled, dose-ranging Phase 2 study. (PubMed, J Am Acad Dermatol) - P2 | "ESK-001 demonstrated significant dose-dependent improvement in signs and symptoms of psoriasis while achieving continuous target inhibition at the highest dose in patients with psoriasis and was well-tolerated."

Clinical • Journal • P2 data • Dermatology • Immunology • Psoriasis • TYK2

...Anticipated Milestones (GlobeNewswire) - "Topline data from ONWARD1 and ONWARD2 are expected early in the first quarter of 2026...A-005 is anticipated to enter a Phase 2 clinical trial in multiple sclerosis in the first half of 2026...Alumis anticipates Phase 1 clinical data from the next program in the second half of 2026."

Clinical data • New P2 trial • Multiple Sclerosis • Psoriasis

ONWARD2: A Study in Patients With Moderate to Severe Plaque Psoriasis to Evaluate the Efficacy and Safety of ESK-001 (clinicaltrials.gov) - P3 | N=840 | Active, not recruiting | Sponsor: Alumis Inc | Recruiting ➔ Active, not recruiting | Trial completion date: Jun 2026 ➔ Dec 2025 | Trial primary completion date: May 2026 ➔ Sep 2025

Enrollment closed • Trial completion date • Trial primary completion date • Dermatology • Immunology • Psoriasis

ONWARD1: A Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - P3 | N=840 | Active, not recruiting | Sponsor: Alumis Inc | Recruiting ➔ Active, not recruiting | Trial completion date: Jun 2026 ➔ Dec 2025 | Trial primary completion date: May 2026 ➔ Sep 2025

Enrollment closed • Trial completion date • Trial primary completion date • Dermatology • Immunology • Psoriasis

Alumis Completes Enrollment of Pivotal Phase 3 ONWARD Clinical Program of Lead Candidate ESK-001, a Highly Selective, Next-Generation Oral TYK2 Inhibitor for the Treatment of Moderate-to-Severe Plaque Psoriasis (GlobeNewswire) - "Alumis Inc...announced the completion of patient enrollment in its pivotal Phase 3 ONWARD clinical program of ESK-001 for the treatment of moderate-to-severe plaque psoriasis...'With over 1,700 patients enrolled across the two trials, this milestone reflects the dedication of our patients, investigators, and the Alumis team'....The Phase 3 ONWARD clinical program consists of two parallel global Phase 3, multi-center, randomized, double-blind placebo-controlled 24-week clinical trials, ONWARD1 and ONWARD2, designed to evaluate the efficacy and safety of ESK-001 in adult patients with moderate-to-severe plaque psoriasis."

Enrollment closed • Psoriasis

Alumis Completes Enrollment of Pivotal Phase 3 ONWARD Clinical Program of Lead Candidate ESK-001, a Highly Selective, Next-Generation Oral TYK2 Inhibitor for the Treatment of Moderate-to-Severe Plaque Psoriasis (Firstwordpharma Press Release) - "Alumis Inc...announced the completion of patient enrollment in its pivotal Phase 3 ONWARD clinical program of ESK-001 for the treatment of moderate-to-severe plaque psoriasis...'With over 1,700 patients enrolled across the two trials, this milestone reflects the dedication of our patients, investigators, and the Alumis team, whose efforts have made it possible. We remain on track to report topline results in early Q1 2026, bringing us closer to delivering transformative treatment solutions for patients in need.'....The Phase 3 ONWARD clinical program consists of two parallel global Phase 3, multi-center, randomized, double-blind placebo-controlled 24-week clinical trials, ONWARD1 and ONWARD2, designed to evaluate the efficacy and safety of ESK-001 in adult patients with moderate-to-severe plaque psoriasis."

Enrollment closed • P3 data: top line • Psoriasis

Maximal and sustained TYK2 inhibition: The key to higher efficacy with oral allosteric inhibitors (SID 2025) - "The 40 mg BID dose of ESK-001 achieved >24-hour IC90 coverage and complete SIGLEC1 suppression in patients, suggesting that maximal inhibition results in higher efficacy. These findings support 40 mg BID as the optimal regimen for treating psoriasis."

Clinical • Dermatology • Immunology • Psoriasis • IFNA1 • IL12A • IL23A • SIGLEC1 • TYK2

ESK-001, an allosteric TYK2 inhibitor, inhibits TYK2-and psoriasis-relevant biomarkers in skin using spatial transcriptomics (SID 2025) - "Disease-relevant bulk and spatial transcriptomic analysis in skin tissue shows decreased expression of key psoriasis biomarkers in non-lesional skin compared to lesional. Analysis after ESK-001 administration further indicates a return of key psoriasis biomarkers to nonlesional baseline levels."

Biomarker • Dermatology • Immunology • Psoriasis • IL17A • KRT16 • TYK2

Anticipated Milestones (GlobeNewswire) - "2025: Planned merger with ACELYRIN: Closing of merger with ACELYRIN (2Q 2025); A-005: Initiation of Phase 2 clinical trial in multiple sclerosis (MS); Lonigutamab: Finalize clinical development plan following the closing of the merger with ACELYRIN (mid-2025); Third pipeline program: Investigational New Drug Application filing for third clinical candidate...2026: ESK-001: Psoriasis Phase 3 topline data (1Q 2026); ESK-001: SLE Phase 2b topline data; A-005: MS Phase 2 topline data."

Clinical data • M&A • New P2 trial • Pipeline update • Multiple Sclerosis • Systemic Lupus Erythematosus • Thyroid Eye Disease

An Investigational Study of ESK-001 in Participants With Normal Renal Function and Participants With Mild, Moderate, and Severe Impaired Renal Function (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Alumis Inc

New P1 trial • Renal Disease

An Investigational Study of ESK-001 in Participants With Normal Liver Function and Participants With Mild, Moderate, and Severe Liver Damage (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Alumis Inc

New P1 trial • Hepatology

Alumis and ACELYRIN Announce Amended Merger Agreement (GlobeNewswire) - "Merger maximizes the potential value for ACELYRIN stockholders and creates a stronger combined company, best-positioned to realize long-term value of multiple late-stage assets...Alumis Inc...and ACELYRIN, INC...announced an amendment to the existing terms of their previously announced merger agreement...Under the terms of the amended agreement, ACELYRIN stockholders will now receive 0.4814 shares of Alumis common stock for each share of ACELYRIN common stock owned, representing a meaningful increase in the ownership percentage of the combined company over the original definitive merger agreement....'We continue to believe that this combination is the most value-maximizing path forward for ACELYRIN stockholders and that Alumis is the right partner to optimize development of lonigutamab.'"

M&A • Immunology • Multiple Sclerosis • Systemic Lupus Erythematosus • Thyroid Eye Disease

Alumis and ACELYRIN File Joint Definitive Proxy Statement for Proposed Merger (GlobeNewswire) - "Alumis Inc...and ACELYRIN, INC...have jointly filed a definitive proxy statement/prospectus with the U.S. Securities and Exchange Commission in connection with the proposed merger of the two companies. The joint proxy statement/prospectus are being mailed to all Alumis and ACELYRIN stockholders entitled to vote...Topline data from Phase 2b LUMUS trial in systemic lupus erythematosus on track for readout in 2026; Phase 2 clinical trial initiation for Alumis’ A-005 in MS...Pro forma cash of approximately $737 million as of December 31, 2024, provides runway into 2027, beyond multiple expected clinical readouts....By combining assets, resources and talent, including members of ACELYRIN’s lonigutamab program, the combined company will be well positioned to maximize the value of its pipeline."

M&A • New P2 trial • P2b data • Multiple Sclerosis • Systemic Lupus Erythematosus • Thyroid Eye Disease

Alumis and Kaken Pharmaceutical Announce Collaboration and Licensing Agreement for ESK-001 in Dermatology in Japan (GlobeNewswire) - "Alumis Inc...and Kaken Pharmaceutical Co., Ltd...announced that the companies have entered into a collaboration and licensing agreement to develop, manufacture and commercialize ESK-001, a highly selective, next-generation oral tyrosine kinase 2 (TYK2) inhibitor, for dermatology indications in Japan, with the option to expand the license to include rheumatological and gastrointestinal diseases...Under the terms of the agreement, Alumis will receive $40 million in upfront and near-term co-development payments in 2025 to 2026, with the potential to earn up to approximately $140 million in additional payments based on the achievement of milestones, and field option payments. Alumis is also eligible to receive tiered royalties ranging from the low double-digits into the twenties on aggregate net sales of ESK-001 in Japan. Kaken will be responsible for the clinical development, regulatory approvals and commercialization of ESK-001 in Japan, and Alumis will retain rights to..."

Licensing / partnership • Psoriasis • Systemic Lupus Erythematosus

Alumis Reports Year End 2024 Financial Results and Highlights Recent Achievements (GlobeNewswire) - "Upon the close of the transaction, Alumis stockholders will own approximately 55% of the combined company and ACELYRIN stockholders will own approximately 45% of the combined company, on a fully diluted basis....Closing of merger transaction with ACELYRIN (2Q 2025)....Research and development expenses were $265.6 million for the year ended December 31, 2024, compared to $137.7 million for the year ended December 31, 2023. The increase was driven by a clinical milestone payment of $23.0 million related to the prior acquisition of FronThera, an increase in contract research and manufacturing and clinical trial costs for the ESK-001 and A-005 programs..."

M&A • Multiple Sclerosis • Psoriasis • Systemic Lupus Erythematosus

Alumis and ACELYRIN Reaffirm Strategic and Financial Rationale of Proposed Merger (GlobeNewswire) - "A combined, differentiated late-stage portfolio of therapies and increased resources enabling the development of life-changing medicines. The combined company will have a diversified portfolio of late-stage clinical assets for validated targets that are set to meaningfully change the treatment paradigm for patients in large, well-established multi-billion dollar markets. These programs, including ESK-001 in moderate-to-severe plaque psoriasis and systemic lupus erythematosus, lonigutamab for thyroid eye disease, and A-005 in multiple sclerosis, offer multiple, high-value catalysts that can be achieved with the financial resources of the combined company...Alumis and ACELYRIN had cash, cash equivalents and marketable securities of approximately $289 million and approximately $448 million, respectively, on a preliminary basis, as of December 31, 2024."

M&A • Multiple Sclerosis • Psoriasis • Systemic Lupus Erythematosus • Thyroid Eye Disease

Late-Breaking ESK-001 Phase 2 OLE Data Presented at 2025 AAD Annual Meeting Demonstrate Robust Clinical Responses Over 52-Weeks in Psoriasis (GlobeNewswire) - P2 | N=165 | NCT05739435 | Sponsor: Alumis Inc | "These data demonstrated that patients receiving 40 mg twice daily dosing of ESK-001 achieved long-term sustained or increasing clinical responses through Week 52 compared to Week 12 (using modified non-responder imputation, n=80) as measured by PASI 90 (61.3% vs. 52.4%), PASI 100 (38.8% vs. 26.8%), and sPGA 0 (38.8% vs. 32.9%). At Week 52, patients maintained robust clinical improvements in control of itch (NRS≤4, 81.3%) and quality-of-life (DLQI0/1, 61.3%). Treatment with ESK-001 continued to be generally well tolerated at week 52, with safety and tolerability consistent with previously reported Week 16 and Week 28 data and no new safety findings."

Late-breaking abstract • P2 data • Psoriasis

Patient-Reported Outcomes in the Phase 2 Studies of ESK-001, an Oral Allosteric TYK2 Inhibitor, in Adults with Moderate-to-Severe Plaque Psoriasis (AAD 2025) - P2 | "ESK-001 was generally safe and well tolerated in both STRIDE and the OLE. No deaths, treatment related AEs associated with the JAK inhibitor class, or clinically significant laboratory or ECG trends were observed."

Clinical • P2 data • Patient reported outcomes • Dermatology • Immunology • Pruritus • Psoriasis • TYK2

Pharmacokinetics, Safety, and Tolerability of ESK-001, an Allosteric TYK2 Inhibitor for Plaque Psoriasis: Evaluation in Asian Populations Compared to Caucasians (AAD 2025) - "No clinically relevant differences in PK parameters, safety, or tolerability were observed across ethnicities, supporting the conclusion that the same therapeutic dosing regimen can be safely used for psoriasis treatment in these populations."

Clinical • PK/PD data • Dermatology • Immunology • Psoriasis • TYK2

ESK-001, an allosteric TYK2 inhibitor, modulates disease and TYK2-related pathway transcriptomic and proteomic biomarkers in Psoriasis STRIDE trial patients (AAD 2025) - "Patients with high intrinsic IL23 pathway expression were most likely to achieve high and rapid PASI response in the dose group with maximal target engagement (40mg BID) compared to those with low expression. Disease-relevant transcriptomic analysis in skin indicates a return of key psoriasis biomarkers to non-lesional baseline levels."

Biomarker • Clinical • Dermatology • Immunology • Psoriasis • IL17A • IL22 • TYK2

Efficacy and safety of ESK-001, a highly selective oral TYK2 inhibitor, in moderate-to-severe plaque psoriasis: long term Phase 2 results (AAD 2025) - No abstract available

Clinical • Late-breaking abstract • P2 data • Dermatology • Immunology • Psoriasis • TYK2