Acelyrin, a biotech company focused on immunology and inflammatory diseases, is shifting its strategic priorities to focus on lonigutamab, an experimental antibody treatment for thyroid eye disease, while halting further investment in izokibep, an injectable anti-inflammatory treatment. This decision comes despite izokibep demonstrating positive results in late-stage clinical trials for hidradenitis suppurativa and psoriatic arthritis.
The company announced that it will discontinue the development of izokibep for these indications, stating that bringing a program of this breadth and size to market is best suited for a larger organization with more resources and an established footprint. Acelyrin will complete the ongoing studies for psoriatic arthritis and hidradenitis suppurativa but will not initiate any new trials. A trial of izokibep in uveitis will continue until its primary endpoint, with results expected in the fourth quarter of this year.
Strategic Prioritization and Layoffs
In conjunction with this strategic shift, Acelyrin is also shelving another early-stage drug, SLRN-517, and reducing its workforce by approximately one-third, affecting about 43 employees. These restructuring moves are intended to extend the company's cash runway to 2027, providing sufficient financial resources to fund two planned Phase 3 trials of lonigutamab.
Focus on Lonigutamab for Thyroid Eye Disease
Acelyrin's primary focus will now be on lonigutamab, a drug for thyroid eye disease that has shown promising results in early testing. The company plans to move directly into Phase 3 testing early next year, bypassing a planned Phase 2b/3 study. Lonigutamab is designed to work similarly to Amgen's Tepezza, an approved treatment for thyroid eye disease, but offers the potential advantage of subcutaneous injection rather than a long infusion.
Market Context and Future Plans
The market for thyroid eye disease treatments has proven lucrative, as demonstrated by the success of Amgen's Tepezza. Acelyrin believes that lonigutamab has the potential to capture a significant share of this market. The company's decision to pivot away from izokibep was driven by strategic prioritization, with all options for izokibep's future being considered, including potential partnerships or licensing deals. However, the company's cash runway guidance does not include any potential proceeds from such deals.
