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ACELYRIN, INC. (Nasdaq: SLRN) is a Los Angeles area-based late-stage clinical biopharmaceutical company with additional operations in the San Francisco Bay area. The company is focused on providing patients with life-changing new treatment options by identifying, acquiring, and accelerating the development and commercialization of transformative medicines. ACELYRIN is at the forefront of innovative treatments in the field of immunology, with a strong pipeline of late-stage clinical programs designed to address significant unmet medical needs.
Core Business: ACELYRIN’s primary focus is on developing transformative therapies in the fields of immunology and inflammation. The company’s lead product candidates include izokibep and lonigutamab. Izokibep is a next-generation inhibitor of IL-17A with a robust potential for tissue penetration and extended half-life. It is being evaluated in multiple late-stage trials targeting moderate-to-severe hidradenitis suppurativa (HS), psoriatic arthritis (PsA), and uveitis. Lonigutamab is a subcutaneously delivered monoclonal antibody targeting the IGF-1 receptor, aimed at treating thyroid eye disease (TED).
Recent Achievements: In March 2024, ACELYRIN announced long-term data from a Phase 2b clinical trial of izokibep in hidradenitis suppurativa, demonstrating significant clinical improvements over time. Additionally, ACELYRIN disclosed positive results from its global Phase 2b/3 clinical trial of izokibep in psoriatic arthritis, which met the primary endpoint of ACR50 with high statistical significance. These results underscore izokibep’s potential as a differentiated treatment option for multiple immunologic conditions.
Current Projects: The company is currently advancing izokibep through Phase 3 trials for hidradenitis suppurativa and psoriatic arthritis. Long-term efficacy results from these trials continue to show promising improvements in quality of life for patients. ACELYRIN is also progressing through a Phase 1/2 trial of lonigutamab for thyroid eye disease, demonstrating rapid clinical benefits and a favorable safety profile.
Financial Condition: As of December 31, 2023, ACELYRIN reported cash, cash equivalents, and short-term marketable securities totaling $721.3 million, which is expected to fund operations into 2026. This financial stability allows ACELYRIN to continue advancing its clinical programs through key developmental milestones.
Partnerships and Collaborations: ACELYRIN leverages strategic collaborations with contract research organizations (CROs) and other vendors to conduct its clinical trials. Despite recent challenges with trial execution errors by its CRO, ACELYRIN remains committed to ensuring quality control and transparency in its clinical development processes.
For more information about ACELYRIN, visit us at www.acelyrin.com or follow us on LinkedIn and X.
ACELYRIN (Nasdaq: SLRN) has received an unsolicited acquisition offer from Concentra Biosciences, controlled by Tang Capital Partners. The offer includes $3.00 per share in cash plus a contingent value right representing 80% of net proceeds from any out-license or disposition of ACELYRIN's development programs or intellectual property.
This offer comes after ACELYRIN's February 6, 2025 announcement of a planned all-stock merger with Alumis Inc. (Nasdaq: ALMS), which is expected to close in Q2 2025, subject to stockholder approvals and customary conditions. The ACELYRIN Board is evaluating the offer while maintaining its commitment to stockholder interests and existing merger agreement obligations.
Alumis and ACELYRIN have announced a merger agreement to create a late-stage clinical biopharma company focused on immune-mediated diseases. The all-stock transaction will result in Alumis stockholders owning ~55% and ACELYRIN stockholders ~45% of the combined company.
The merged entity will operate under the Alumis name with a pro forma cash position of approximately $737 million as of December 31, 2024, providing runway into 2027. Key pipeline assets include ESK-001, currently in Phase 3 trials for psoriasis with topline data expected in H1 2026, and lonigutamab for thyroid eye disease.
The transaction is expected to close in Q2 2025, subject to stockholder approval. The combined company will be led by the current Alumis executive team and headquartered in South San Francisco.
ACELYRIN (SLRN) has announced additional Phase 2 data and Phase 3 program design for lonigutamab in Thyroid Eye Disease (TED). The Phase 2 trial demonstrated clinically meaningful improvements across TED manifestations, including proptosis, Clinical Activity Score, and diplopia. The drug showed significant response rates with a 50 mg loading and 25 mg weekly subcutaneous dose.
The Phase 3 LONGITUDE program will include two global trials across ~350 patients, evaluating a 100 mg loading dose followed by 50 mg every two weeks. The trials will begin in Q1 2025, with topline data expected in second half of 2026. LONGITUDE-1 and 2 will study both 'active' and 'chronic' TED patients, with primary endpoints measuring proptosis response rate at 24 weeks.
The company received FDA alignment on the Phase 3 trial designs in Q3 2024 and maintains a cash runway through mid-2027.
ACELYRIN (Nasdaq: SLRN) announced a virtual investor event scheduled for January 6, 2025, at 4:30 PM ET. The event will present updated Phase 2 data for subcutaneous lonigutamab in Thyroid Eye Disease (TED) treatment, highlighting its potential for best-in-class efficacy and safety profile.
The company will also unveil the design of their Phase 3 LONGITUDE program, developed after a successful End-of-Phase 2 FDA meeting, which aims to be the most inclusive registrational program in TED to date. The presentation will feature external clinical perspectives from Stanford and University of Colorado School of Medicine experts on TED's unmet needs.
ACELYRIN (Nasdaq: SLRN) announced that its Phase 2b/3 trial of izokibep in non-infectious, non-anterior uveitis failed to meet its primary endpoint of showing statistically significant improvement in time to treatment failure versus placebo at 24 weeks. Secondary endpoints also did not achieve statistical significance.
Following these results and previous guidance, ACELYRIN will discontinue internal investment in izokibep development. The company will focus on advancing lonigutamab for thyroid eye disease (TED), with Phase 3 trials scheduled to begin in Q1 2025. The company reports $562.4 million in cash and equivalents as of September 30, 2024, providing runway until mid-2027.
ACELYRIN (NASDAQ: SLRN) reported Q3 2024 financial results with key updates on its pipeline. The company expects topline data from izokibep's Phase 2b/3 trial for uveitis treatment in December 2024. Following positive FDA interaction, lonigutamab's Phase 3 development for thyroid eye disease will begin in Q1 2025. Financial highlights include cash position of $562.4 million expected to fund operations until mid-2027, R&D expenses of $31.6 million (down from $74.6 million in Q3 2023), and net loss of $48.5 million (improved from $83.9 million in Q3 2023). The quarter included $10.8 million in restructuring expenses related to pipeline refocusing.
ACELYRIN (Nasdaq: SLRN) will report its third quarter 2024 financial results and provide a corporate update on November 13, 2024, at 4:30 p.m. ET. The company focuses on developing transformative medicines in immunology. A live webcast of the conference call will be available on ACELYRIN's website under Events & Presentations, with a replay accessible for 90 days.
ACELYRIN, INC. (Nasdaq: SLRN) has formed a scientific and patient advisory board comprising leading experts and advocates in thyroid eye disease (TED). This board will provide strategic input, clinical expertise, and patient perspectives as ACELYRIN prepares to advance lonigutamab, a subcutaneously delivered IgG1 monoclonal antibody targeting the anti-insulin-like growth factor 1 (IGF-1) receptor, into Phase 3 clinical development for TED in the first quarter of 2025.
The advisory board includes renowned scientific advisors and a patient advocate, each bringing distinct expertise in TED. ACELYRIN aims to leverage their collective insights to execute its goal of delivering a potentially best-in-class subcutaneous anti-IGF-1R treatment for TED patients.
ACELYRIN, INC. (Nasdaq: SLRN) announced positive results from its global Phase 3 clinical trial of izokibep in moderate-to-severe hidradenitis suppurativa (HS) patients. The results will be presented at the 2024 European Academy of Dermatology and Venereology in Amsterdam. The trial demonstrated statistically significant and clinically meaningful responses across multiple efficacy endpoints, particularly in higher order responses like HiSCR90 and HiSCR100, by 12 weeks. Dr. Shephard Mpofu, Chief Medical Officer of ACELYRIN, believes these data could support a path to regulatory approval for izokibep as a treatment for HS.
ACELYRIN, INC. (Nasdaq: SLRN) announced positive data from its Phase 1/2 clinical trial of lonigutamab for thyroid eye disease (TED) will be presented at the 42nd Annual Meeting of the European Society of Ophthalmic Plastic and Reconstructive Surgery. The presentation, titled 'Preliminary Safety, Efficacy, and Quality of Life Outcomes of Subcutaneous Lonigutamab from a Phase 1/2 Proof of Concept Study in Patients with Thyroid Eye Disease,' will take place on September 14, 2024, in Rotterdam, Netherlands.
Dr. Jwu Jin Khong will deliver the rapid-fire oral presentation. ACELYRIN's Chief Medical Officer, Dr. Shephard Mpofu, highlighted the potential of lonigutamab to improve clinical outcomes through rapid suppression of IGF-1 receptor signaling, achieving robust responses with low drug exposures. The company believes the data supports the potential for subcutaneously-delivered lonigutamab to provide deep and durable responses with convenient, self-administered dosing.
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