From GlobeNewswire: 2024-05-09 08:01:00

ACELYRIN, INC. provided an update on corporate milestones, including completion of Phase 3 trial enrollment for izokibep in hidradenitis suppurativa and Phase 2b/3 trial enrollment in uveitis. Positive results were reported for lonigutamab in thyroid eye disease and top-line data for izokibep in psoriatic arthritis. Financials and leadership team changes were also announced. Top-line data for both trials are expected by the end of the third and fourth quarter of 2024, respectively. Cash, cash equivalents, and short-term marketable securities as of March 31, 2024, were reported at $678.5 million. Major milestones for various pipeline products were outlined, including Phase 3 trial data for izokibep in HS expected in the third quarter of 2024.Thyroid Eye Disease ACELYRIN reported positive proof-of-concept data for lonigutamab in thyroid eye disease. The Phase 1/2 trial is ongoing to determine optimal dosing for a Phase 2b/3 trial, planned to start in the second half of 2024. The company anticipates top-line data for uveitis Phase 2b/3 trial by year-end 2024.Lonigutamab, a subcutaneously delivered monoclonal antibody targeting IGF-1R, showed positive results in thyroid eye disease Phase 1/2 trial. Rapid improvements were seen in proptosis and clinical activity score within three weeks of the first dose. Izokibep, an IL-17A inhibitor, delivered positive top-line Phase 2b/3 data in psoriatic arthritis, demonstrating high statistical significance and significant multi-domain responses. The optimal clinically effective dose was established at 160mg every two weeks. The Phase 2b/3 trial is expected to be registration-enabling.ACELYRIN has reaffirmed cash expectations into 2026, with $678.5 million in cash, cash equivalents, and short-term marketable securities as of March 31, 2024. The company is actively considering options to extend its cash runway. Additionally, leadership team changes were announced, with Mina Kim appointed CEO and Dr. Shao-Lee stepping down. Dr. Shephard Mpofu was promoted to Chief Medical Officer, and Gil Labrucherie was named Chief Business Officer in addition to CFO. Sanam Pangali was promoted to Chief Legal Officer and Head of People. The company will participate in the Jefferies Global Healthcare Conference and forego its Q1 2024 earnings call. For more information, visit ACELYRIN’s website.



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