ACELYRIN, Inc. (SLRN), a biopharmaceutical company with a market capitalization of $383 million, announced today additional Phase 2 data for its investigational treatment, lonigutamab, for thyroid eye disease (TED) and details of the Phase 3 LONGITUDE program design. According to InvestingPro data, the stock has shown strong momentum with a 24% gain over the past week.
The new data showed lonigutamab's clinically meaningful improvements in TED symptoms, including eye protrusion, inflammation, double vision, and quality of life, without reported cases of hearing impairment, high blood sugar, or menstrual disorders to date.
The Phase 3 LONGITUDE program will consist of two global double-masked, placebo-controlled trials involving approximately 350 patients. The trials will assess the safety and efficacy of a 100mg loading dose of lonigutamab followed by a 50mg dose every two weeks. InvestingPro analysis shows the company maintains a strong liquidity position with a current ratio of 7.15, though it's currently experiencing significant cash burn. The primary endpoint is the proptosis response rate at 24 weeks. All participants will receive the drug from 24 to 52 weeks, potentially allowing long-term treatment benefits.
ACELYRIN has aligned with the U.S. Food and Drug Administration on the Phase 3 trial designs after an end-of-Phase 2 meeting. The company plans to initiate the LONGITUDE program in the first quarter of 2025 and expects to report top-line data in the second half of 2026.
These forward-looking statements are subject to risks and uncertainties that could affect the company's actual results. ACELYRIN's future reports to the Securities and Exchange Commission will provide further details on risk factors and other conditions that may impact the company's operations and projections.
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In other recent news, Acelyrin Inc. has made significant strides in its clinical trials. The biopharmaceutical firm has advanced its drug lonigutamab into Phase 3 trials for the treatment of Thyroid Eye Disease (TED), following promising Phase 2 data. The Phase 3 program, named LONGITUDE, is set to commence in the first quarter of 2025, with topline data expected in the latter half of 2026.
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