LOS ANGELES - Acelyrin Inc. (NASDAQ:SLRN), a biopharmaceutical company specializing in immunology treatments, has announced promising early results from its Phase 1/2 trial for lonigutamab, a potential new therapy for thyroid eye disease (TED). The medication, a subcutaneously delivered monoclonal antibody targeting the IGF-1 receptor, showed rapid improvements in proptosis, clinical activity scores, and diplopia compared to placebo, with a favorable safety profile.
The trial data revealed that within three weeks of the first subcutaneous dose, patients experienced significant improvements. Specifically, 50% of patients in the first cohort and 67% in the second cohort saw a reduction in proptosis.
Clinical activity scores improved for all patients in the first cohort and 83% in the second cohort. Additionally, 25% of patients in the first cohort and 40% in the second cohort experienced improvements in diplopia, a condition of double vision.
Dr. Shao-Lee Lin, CEO of Acelyrin, expressed optimism regarding the potential of lonigutamab to offer a more convenient and safer treatment option for TED patients, given its subcutaneous administration and rapid response. The absence of serious adverse events, such as hyperglycemia or hearing impairment, further supports the therapy's favorable safety profile.
The trial is ongoing, with further data expected to be presented at future scientific meetings. Acelyrin plans to initiate a Phase 2b/3 trial in the second half of 2024, which is designed to be the first of two registrational trials for this condition.
TED is an autoimmune disease that can lead to eye bulging, difficulty closing eyelids, double vision, and potentially blindness. It is estimated that over 100,000 people in the United States suffer from this condition.
Acelyrin has decided not to host a fiscal year 2023 earnings call but will announce financial results in a press release and file the related 10-K report by April 1, 2024. A conference call to review the clinical data was held today, with a recording available on the company's website.
The information in this article is based on a press release statement from Acelyrin Inc.
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