Acelyrin, Inc. (Nasdaq: SLRN) has provided an update on its clinical programs and business strategy, highlighting key milestones for its lead drug candidates, izokibep and lonigutamab. The company anticipates significant data readouts and trial initiations in the coming months, while also focusing on capital efficiency and strategic decision-making.
Izokibep Development
Izokibep, a small protein therapeutic designed to inhibit IL-17A, is currently being evaluated in multiple late-stage trials. Enrollment in the Phase 3 trial for moderate-to-severe hidradenitis suppurativa (HS) has been completed, with 258 patients enrolled. Top-line data from this trial, which is expected to be the first of two registrational trials, are anticipated in the third quarter of 2024.
In addition, Acelyrin expects to complete enrollment in the Phase 2b/3 trial of izokibep for non-infectious uveitis (UV) this month. Top-line data from this trial are anticipated by the end of 2024. The company recently reported positive top-line data from the Phase 2b/3 clinical trial evaluating izokibep in psoriatic arthritis (PsA). The trial met its primary endpoint of ACR50 at 16 weeks with high statistical significance and showed significant, multi-domain responses for ACR70, PASI100, as well as composite endpoints ACR50/PASI100 and Minimal Disease Activity.
Lonigutamab Program
Lonigutamab, a subcutaneously delivered humanized IgG1 monoclonal antibody targeting the insulin-like growth factor-1 receptor (IGF-1R), has shown promise in early-stage development for thyroid eye disease (TED). Acelyrin recently reported positive proof-of-concept data from an ongoing Phase 1/2 trial, demonstrating rapid improvements in proptosis and clinical activity score (CAS) within three weeks after the first subcutaneous dose. These results were comparable to intravenous approaches, with lonigutamab being well-tolerated.
A Phase 2b/3 trial, designed to be the first of two registrational trials in TED, is planned to be initiated in the second half of 2024. The company is currently evaluating data from the Phase 1/2 trial to determine the optimal dose and dose regimen for the Phase 2b/3 trial.
Financial Position and Leadership Changes
Acelyrin expects to report cash, cash equivalents, and short-term marketable securities of $678.5 million at March 31, 2024. The company reiterates its guidance that its cash position is expected to fund operations into 2026 and is actively considering alternatives to further extend its cash runway.
The company also announced leadership changes, with Mina Kim appointed as Chief Executive Officer and Shephard (Shep) Mpofu, M.D., MRCP, FRCP, promoted to Chief Medical Officer. Gil Labrucherie has been named Chief Business Officer in addition to Chief Financial Officer, and Sanam Pangali has been promoted to Chief Legal Officer and Head of People.
