Alumis Advances Phase 3 ONWARD Program for ESK-001 Treatment

Alumis Completes Enrollment in Phase 3 ONWARD Clinical Trials

Alumis Inc. (NASDAQ: ALMS), a pioneering biopharmaceutical company dedicated to developing innovative therapies for immune-mediated conditions, has successfully completed patient enrollment in its pivotal Phase 3 ONWARD clinical program for ESK-001. This advanced oral TYK2 inhibitor targets moderate-to-severe plaque psoriasis, a condition that affects many individuals' quality of life.

Significant Milestone Achieved

Martin Babler, the President and CEO of Alumis, expressed the company’s excitement over this achievement, noting that over 1,700 patients participated across two major clinical trials. This significant enrollment milestone showcases the hard work and commitment of patients, healthcare professionals, and the dedicated Alumis team. The company anticipates delivering topline results in the early stages of 2026, moving closer to offering transformative treatments to those in need.

Patient-Centered Development Approach

As the clinical development of ESK-001 progresses, the challenges that patients with moderate-to-severe plaque psoriasis encounter become increasingly evident. Dr. Jörn Drappa, the Chief Medical Officer of Alumis, highlighted that many patients often switch between treatment options due to the inconvenience associated with injectable biologics and the declining efficacy of available oral treatments. ESK-001 is poised to change this dynamic, offering a well-tolerated, oral option that delivers effective, biologic-like responses sustainably.

Understanding the ONWARD Program

The ONWARD program consists of two parallel, global Phase 3 trials, ONWARD1 and ONWARD2, which are randomized, double-blind, and placebo-controlled, spanning 24 weeks. This rigorous design is aimed at assessing the safety and efficacy of ESK-001 in adult patients diagnosed with moderate-to-severe plaque psoriasis. An optional long-term extension trial, ONWARD3, is underway, providing patients completing the initial study with an opportunity to evaluate the treatment's durability and long-term safety.

About ESK-001

ESK-001 represents Alumis' lead candidate and exemplifies a next-generation, highly selective oral TYK2 inhibitor. Its innovative formulation aims to modulate immune responses across various conditions characterized by pro-inflammatory mechanisms, including IL-23, IL-17, and type 1 interferons. The strategic selection of ESK-001 is intended to maximize therapeutic effects while reducing unintended side effects.

Clinical Insights from Trials

The efficacy and safety of ESK-001 are currently being examined in the ONWARD clinical trials, which have shown promising initial results. This robust program is supported by favorable data from the earlier Phase 2 STRIDE trial and ongoing open-label extensions. Notably, participants in ONWARD1 and ONWARD2 are randomized into three groups to receive either ESK-001 or other control treatments, and key effectiveness measures are centered around achieving significant improvements in psoriasis severity.

Extending ESK-001's Reach

In parallel with the ONWARD program, Alumis is also exploring ESK-001's potential use in the treatment of systemic lupus erythematosus through the LUMUS Phase 2b clinical trial. This broadens the scope of ESK-001 beyond psoriasis, aiming for comprehensive solutions for diverse immune-mediated disorders. Moreover, Alumis continues to refine its oral TYK2 inhibitor pipeline, which includes a once-daily modified formulation that enhances patient adherence.

About Alumis

Alumis is committed to advancing healthcare by developing groundbreaking targeted therapies designed to significantly enhance patient outcomes across a variety of immune-mediated diseases. The company leverages cutting-edge data analytics and a precise research approach to innovate treatments, striving to address critical health challenges faced by patients. The company's pipeline also includes A-005 for neuroinflammatory conditions and lonigutamab for thyroid eye disease, showcasing a diversified therapeutic portfolio.

Frequently Asked Questions

What is ESK-001 designed to treat?

ESK-001 is primarily developed to treat moderate-to-severe plaque psoriasis and is being evaluated in ongoing clinical trials.

How many patients were enrolled in the ONWARD clinical trials?

Over 1,700 patients were enrolled across two pivotal Phase 3 trials within the ONWARD clinical program.

What are the goals of the ONWARD clinical trials?

The trials aim to assess the safety and efficacy of ESK-001 in treating psoriasis, along with evaluating long-term effects through subsequent studies.

What is the significance of Alumis' pipeline?

Alumis' pipeline focuses on next-generation therapies for various immune-mediated diseases, including further developments in tyrosine kinase inhibitors.

Where can I find more information about Alumis?

For comprehensive insights and updates, you can visit Alumis' official website or connect with them on LinkedIn or X.

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