LOS ANGELES - ACELYRIN, INC. (NASDAQ:SLRN), a late-stage biopharmaceutical company with a market capitalization of $383 million, today announced the advancement of its drug lonigutamab into Phase 3 trials for the treatment of Thyroid Eye Disease (TED), following promising Phase 2 data. The stock has shown strong momentum recently, gaining 24% in the past week, though it remains 48% lower than a year ago. According to InvestingPro analysis, the stock appears fairly valued based on its proprietary Fair Value model. The Phase 3 program, called LONGITUDE, is set to begin in the first quarter of 2025, with topline data expected in the latter half of 2026.
Lonigutamab is a monoclonal antibody targeting the insulin-like growth factor 1 (IGF-1) receptor and is delivered subcutaneously. It is the first of its kind to show robust efficacy in TED patients, comparable to intravenously administered standard care, but potentially with a better safety profile. The drug has not shown cases of hearing impairment, hyperglycemia, or menstrual disorders, which are significant considerations for patient safety.
The Phase 2 trial demonstrated clinically meaningful improvements across various manifestations of TED, including proptosis, Clinical Activity Score (CAS), and diplopia, as well as quality of life measures. A 100 mg loading dose of lonigutamab achieved target therapeutic concentration rapidly, suggesting potential for swift therapeutic effects.
The upcoming Phase 3 trials, LONGITUDE-1 and LONGITUDE-2, will be double-masked, placebo-controlled studies involving approximately 350 patients globally. The trials will assess the safety and efficacy of a 100 mg loading dose followed by 50 mg every two weeks. The primary endpoint will be the proptosis response rate at 24 weeks, with secondary endpoints including CAS, diplopia response, and quality of life at the same time frame.
ACELYRIN has aligned with the U.S. Food and Drug Administration (FDA) on the design of the Phase 3 trials during an End of Phase 2 meeting in the third quarter of 2024. The company’s cash runway is expected to extend through mid-2027, covering the duration of the trial and beyond. InvestingPro data shows the company maintains a strong liquidity position with a current ratio of 7.15 and more cash than debt on its balance sheet, though it is rapidly burning through cash reserves. These are just two of several key insights available in the comprehensive Pro Research Report, which provides deep-dive analysis of 1,400+ top stocks.
Mina Kim, CEO of ACELYRIN, expressed confidence in the potential of lonigutamab to optimize patient benefit and risk and transform the TED treatment paradigm. Dr. Shep Mpofu, Chief Medical (TASE:PMCN) Officer at ACELYRIN, also noted the company’s commitment to addressing the significant unmet needs of TED patients with this novel therapy.
A virtual investor event to discuss the new Phase 2 data and the Phase 3 program design is scheduled for today, with participation from leading medical experts. The information in this article is based on a press release statement from ACELYRIN. Analysts maintain a positive outlook on the company, with price targets ranging from $5 to $20 per share. For deeper insights into ACELYRIN’s financial health, growth prospects, and detailed analyst recommendations, visit InvestingPro, where subscribers can access exclusive financial metrics and expert analysis.
In other recent news, Acelyrin Inc. has been actively advancing its clinical trials and financial stability. The biopharmaceutical company recently reported that its Phase 2b/3 study of izokibep for uveitis treatment did not meet the primary endpoint. Despite this, H.C. Wainwright maintained a neutral rating on Acelyrin’s shares, while TD Cowen kept its Buy rating, highlighting the progress of lonafarnib, Acelyrin’s lead program for thyroid eye disease (TED).
The company’s third-quarter 2024 earnings call revealed a decrease in R&D expenses and an updated year-end cash guidance. As of Q3, Acelyrin held $562.4 million in cash, with the year-end cash guidance revised to $435 million to $450 million. Acelyrin also announced plans to acquire global rights to lonigutamab for $31 million.
Moreover, Acelyrin is progressing with its Phase II study of lonafarnib for TED, having completed its first three cohorts. The company is expected to share Phase II data and Phase III trial design details in the first quarter, following a meeting with regulatory authorities. The company’s strategic focus remains on advancing its clinical pipeline and maintaining financial stability.
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