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Alumis' Envudeucitinib Delivers Early and Robust Improvements in Skin Clearance, Quality of Life and Psoriasis Symptoms in Two Phase 3 Trials, Underscoring Its Potential as a Leading Oral Therapy for Plaque Psoriasis
Globenewswire· 2026-03-28 17:30
Envudeucitinib achieved robust PASI responses by Week 16, with significant continued improvements by Week 24 in PASI 90 (68.0%, 62.1%) and PASI 100 (41.0%, 39.5%)Quality‑of‑life improvements and itch relief emerged ahead of PASI 90 skin clearance, and clear or almost clear scalp psoriasis emerged by Week 4, highlighting envudeucitinib’s early onset and broad clinical benefitEnvudeucitinib demonstrated a favorable safety and tolerability profile consistent with the Phase 2 programResults presented as a late- ...
Alumis (ALMS) Earnings Call Presentation
2025-09-03 12:00
Financial Status and Pipeline - Alumis had $486.3 million in cash, cash equivalents, and marketable securities as of June 30, 2025, expected to fund operations into 2027[12] - The company has a portfolio of three clinical molecules against validated targets, including Envudeucitinib, A-005, and Lonigutamab, plus multiple pipeline assets in late-stage research[12] Envudeucitinib (TYK2 Inhibitor) - Phase 3 topline data for Envudeucitinib in Psoriasis is expected in early Q1 2026, and Phase 2b topline data for SLE is expected in Q3 2026[12] - Envudeucitinib targets a market opportunity greater than $4 billion in SLE[27, 75] - In a Phase 2 trial, Envudeucitinib demonstrated high statistical significance at Week 12 (PASI 75: p < 0001)[45] - Approximately 75% of psoriasis patients prefer an oral therapy[25, 33, 40] A-005 (CNS Penetrant TYK2 Inhibitor) - A-005 is a first-in-class brain-penetrant TYK2 inhibitor for neuroinflammation and neurodegeneration, with Phase 2 initiation in MS expected in 1H 2026[14, 16] - A-005 demonstrated full CNS penetration in Phase 1, with doses established to provide high peripheral and CSF exposure[29, 86] Lonigutamab (Anti-IGF-1R Therapy) - Lonigutamab is an anti-IGF-1R therapy with a unique MOA for Thyroid Eye Disease (TED), with development program evaluation ongoing[12, 16] Market Opportunities - Near-term results could unlock interferon and IL-23 pathway-driven diseases with global market opportunities greater than $150 billion[15] - Approximately 16 million people worldwide have moderate-to-severe psoriasis, representing a global market of over $25 billion[40] Kaken Collaboration - Alumis is receiving $40 million near-term for Japan, which is less than 5% of the worldwide psoriasis market (estimated at $600 million in 2024), highlighting significant opportunity for Alumis in ROW[72]
Alumis (ALMS) 2025 Conference Transcript
2025-06-04 20:10
Summary of Illumis (ALMS) Conference Call Company Overview - Illumis recently completed a merger with Accelerin to strengthen its position as a leading immunology company [2][3] - The merger aims to combine their pipelines and financial resources to build a well-capitalized precision immunology company [3] Key Pipeline Developments - Upcoming key readouts include: - Psoriasis readout expected in early 2026 after completing enrollment of over 1,700 patients in a Phase III trial [4][7] - Lupus readout planned for next year, with ongoing Phase II trial expected to complete enrollment by summer [5][8] - The company has a cash runway into 2027, with approximately $600 million in cash and 100 million shares outstanding [6] Psoriasis Program - The psoriasis program is in Phase III, with a six-month readout expected early in 2026 [4][7] - The trial has been completed ahead of schedule, indicating strong patient interest [7] - The company is focused on maximizing target inhibition with its TYK2 inhibitors, which have shown promising results in clinical trials [12][21] Lupus Program - The lupus program is designed as a pivotal trial to demonstrate significant efficacy over placebo [43] - The company aims to reduce the placebo effect by ensuring strict patient selection and monitoring [44] - The ongoing study is expected to read out in 2026, with a focus on genetic validation for TYK2 inhibition in lupus patients [38][40] Competitive Landscape - The psoriasis market is competitive, but injectable biologics account for less than 10% of treatments, indicating a significant opportunity for effective oral therapies [34][35] - The company aims to capture a portion of the market by offering a highly efficacious and safe oral drug [34] Differentiation and Safety Profile - Illumis emphasizes the importance of maximum target inhibition for efficacy and safety, with ongoing studies supporting this hypothesis [20][21] - The safety profile of their drugs has been favorable, with no significant safety findings reported to date [24][25] Future Milestones - The company plans to initiate a Phase II trial for its brain-penetrant TYK2 inhibitor, A5, later this year [52][56] - A once-a-day formulation for ESK001 is also in development, with plans to announce details later this year [57] - Key readouts for psoriasis and lupus are anticipated in 2026, along with potential updates on MS and lanagutamab [58] External Validation - A partnership with Kakken in Japan for the development of ESK001 has provided external validation and a significant financial boost [46] Conclusion - Illumis is strategically positioned in the immunology space with a robust pipeline and a focus on maximizing efficacy and safety through innovative drug development and strategic partnerships [2][3][34]