ACELYRIN, INC. Announces Additional Phase 2 Data and Phase 3 Program Design for Lonigutamab in Thyroid Eye Disease

Core Insights - The data from the Phase 2 trial of lonigutamab in Thyroid Eye Disease (TED) patients indicates potential efficacy comparable to standard care and a favorable safety profile [1][2] - The Phase 3 program is set to begin in Q1 2025, with topline data expected in the second half of 2026 [1][3] - A conference call is scheduled to discuss the unmet needs in TED and the new Phase 2 data [1] Phase 2 Data - Lonigutamab has shown robust efficacy in TED patients, with no reported cases of hearing impairment, hyperglycemia, or menstrual disorders [2][6] - The drug demonstrated significant proptosis response rates with a 50 mg loading dose and 25 mg weekly subcutaneous dose [6] Phase 3 Program Design - The Phase 3 LONGITUDE program will include two global double-masked, placebo-controlled trials involving approximately 350 patients [4] - Patients will receive a 100 mg loading dose of lonigutamab followed by 50 mg every two weeks, with a primary endpoint of proptosis response rate at 24 weeks [4][5] - LONGITUDE-1 will focus on active TED patients, while LONGITUDE-2 will include both active and chronic TED patients [5] Safety and Efficacy - Lonigutamab is expected to achieve therapeutic concentrations quickly, with a potential for improved safety and convenience compared to current treatments [11][8] - The drug's unique mechanism allows for subcutaneous delivery, which may enhance the depth and durability of clinical responses [11] Company Overview - ACELYRIN, INC. is focused on developing transformative medicines in immunology, with lonigutamab as its lead program for TED [12] - The company aims to address significant unmet needs in TED treatment through its innovative approach [8]