(RTTNews) - Shares of ACELYRIN, Inc. (SLRN) are down over 17% in premarket trading, following disappointing results from its Phase 2b/3 trial of Izokibep in non-infectious, non-anterior uveitis.
Izokibep, the company's lead drug candidate, is a subcutaneously delivered monoclonal antibody targeting IL-17A.
In the Phase 2b/3 clinical trial of Izokibep in uveitis, neither the primary endpoint nor secondary endpoints were met.
The primary endpoint of the study was an improvement in time to treatment failure versus placebo as measured by treatment failure rates at 24 weeks. This was not met. The treatment failure rate at 24 weeks was 45.0% for Izokibep and 50.7% for placebo.
Additionally, none of the secondary endpoints, including changes in visual acuity or retinal thickness, showed clinical benefit.
The company has now shifted its focus to Lonigutamab, a subcutaneous monoclonal antibody targeting IGF-1R, being developed for the treatment of thyroid eye disease (TED).
ACELYRIN is on track to initiate its Phase 3 program for Lonigutamab in the first quarter of 2025.
ACELYRIN also has a strong financial position with $562.4 million in cash, cash equivalents, and short-term marketable securities as of September 30, 2024, which is expected to sustain the company through mid-2027.
This financial runway will support the ongoing Phase 3 trials for Lonigutamab and other selective pipeline expansion activities.
Looking ahead, the company's strategic focus remains on advancing Lonigutamab for TED, and investors will be watching closely as ACELYRIN progresses toward key milestones in 2025.
SLRN closed Tuesday's (Dec. 10, 2024) trading at $4.06, down 5.36%. In premarket trading Wednesday, the stock is down over 17% at $3.35.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
