ACELYRIN to Present Lonigutamab Phase 1/2 Data at ENDO 2024
ACELYRIN, INC., a biopharmaceutical company at the forefront of developing transformative treatments for immunological diseases, has revealed promising results from its ongoing Phase 1/2 clinical trial of lonigutamab for treating thyroid eye disease (TED). The data will be presented during the Endocrine Society’s Annual Meeting (ENDO 2024) in Boston, MA, from June 1-4. Lonigutamab, administered subcutaneously, is a humanized IgG1 monoclonal antibody designed to target the insulin-like growth factor-1 receptor (IGF-1R), a mechanism already FDA-approved for TED treatment.
The trial's findings will be shared in a presentation titled "Preliminary Safety And Efficacy Of Subcutaneous Lonigutamab (anti-IGF-1R) From A Phase 1/2 Proof Of Concept Study In Patients With Thyroid Eye Disease," scheduled for June 3. Dr. Shoaib Ugradar from the Department of Orbital and Oculoplastic Surgery at The Jules Stein Eye Institute, University of California, will lead the presentation.
The Phase 1/2 trial (NCT05683496) is a multi-center study exploring the safety and efficacy of subcutaneously administered lonigutamab in patients with active TED. The trial consists of three patient cohorts. The first cohort is placebo-controlled, testing 40mg of lonigutamab every three weeks for six weeks. The second cohort is open-label, with a 50mg loading dose followed by 25mg weekly. The third cohort tests the open-label dosing every four weeks.
Thyroid eye disease is an autoimmune condition that causes inflammation and expansion of tissues behind the eye, leading to symptoms like eye bulging (proptosis), double vision (diplopia), and potential retinal nerve compression, which can cause blindness. The disease is progressive and chronic, highlighting the need for prolonged treatment to achieve substantial and lasting clinical responses. An estimated 100,000 people in the United States suffer from TED.
Lonigutamab's innovative approach targets the IGF-1 receptor, binding to a specific epitope that triggers receptor internalization within minutes. Preclinical studies have shown lonigutamab to be 75 times more potent compared to standard treatments. This potency, combined with its subcutaneous delivery method, could allow for sustained dosing and potentially enhance the depth and durability of clinical responses. Data from single ascending dose studies suggest optimizing the therapeutic window through this administration route.
ACELYRIN, INC., based in the Los Angeles area with additional operations in the San Francisco Bay area, is dedicated to delivering life-changing treatments. Aside from lonigutamab, which is advancing to Phase 2b/3 for TED treatment, ACELYRIN is also developing izokibep, a next-generation IL-17A inhibitor in late-stage trials for conditions such as psoriatic arthritis, hidradenitis suppurativa, and uveitis.
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