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ACELYRIN, INC. (Nasdaq: SLRN) is a late-stage clinical biopharmaceutical company focused on developing and commercializing transformative medicines to address unmet medical needs. Headquartered in the Los Angeles area with additional operations in the San Francisco Bay area, the company specializes in identifying and accelerating the development of innovative therapies. ACELYRIN does not currently have any approved products for commercial sale and is primarily engaged in clinical development activities.
- Izokibep - A small protein therapeutic designed to inhibit IL-17A, currently in late-stage clinical trials for hidradenitis suppurativa, psoriatic arthritis, and uveitis, with plans for axial spondyloarthritis.
- Lonigutamab - A monoclonal antibody targeting the IGF-1 receptor, being developed for the treatment of Thyroid Eye Disease (TED).
- SLRN-517 - A monoclonal antibody targeting c-KIT, under development for chronic urticaria.
- Given the potential for hearing-related adverse events with anti-IGF-1R agents like lonigutamab, can you elaborate on how your Phase III dosing strategy aims to mitigate these risks, and what thresholds for hearing impairment are acceptable for regulatory approval?
- With biologic-experienced patients included in your izokibep uveitis trial—unlike the VISUAL I study for adalimumab—how might this affect the efficacy outcomes, and how will you interpret the data in the context of these differing patient populations?
- Considering your cash runway projections to mid-2027 exclude new investments in izokibep, what specific criteria will you use to decide whether to advance izokibep into a Phase III uveitis trial, and how would this impact your financial guidance?
- How do you plan to balance further development of izokibep, given the $35.7 million manufacturing credit voucher, with your primary focus on lonigutamab, and what factors would trigger renewed investment in the izokibep program?
- As you plan to extend dosing of lonigutamab to 52 weeks in both active and inactive TED patients, what evidence supports the long-term safety and efficacy over this extended period, and how have regulators responded to this approach compared to standard treatment durations?