– Results demonstrate consistent improvements across measures of disease activity, quality of life, and pharmacodynamic markers, with a tolerable safety profile across all afimetoran dose groups –
– Safety and efficacy data reinforce afimetoran’s profile as a potential best-in-class oral therapy for lupus and support planned pivotal development across systemic and cutaneous disease –
– Presentation will take place on Wednesday, November 11 at 9:00 AM EST –
STAMFORD, Conn., Oct. 27, 2026 (GLOBE NEWSWIRE) -- Beeline Medicines Corporation, a clinical-stage biotechnology company focused on developing and delivering category-leading precision therapies to transform the lives of people with autoimmune and inflammatory diseases, today announced that the Phase 2 trial data of afimetoran in systemic lupus erythematosus (SLE) will be presented as a late-breaking oral presentation at the American College of Rheumatology (ACR) Convergence 2026, taking place November 6–11, 2026, in Orlando, Florida.
Afimetoran is an investigational oral, once-daily, equipotent inhibitor of Toll-like receptors 7 and 8 (TLR7 and TLR8), targets that play complementary and critical roles in lupus pathogenesis. By inhibiting both receptors with equal potency, afimetoran is designed to suppress disease-driving activity across innate immune cells and B cells, two key drivers of immune response in systemic and cutaneous lupus. This approach is supported by the rapid, near-maximal suppression of type I interferon signaling consistently observed in clinical studies to date.
“Lupus remains one of the most underserved major autoimmune diseases. Treatment options are limited, and far too many patients remain reliant on therapies that do not adequately control their disease,” said Saqib Islam, Chief Executive Officer of Beeline Medicines. “The depth and breadth of disease improvements demonstrated in our Phase 2 SLE study, including in the skin and joint manifestations that affect so many people living with lupus, deepen our conviction in afimetoran’s best-in-class potential. We look forward to presenting the results at ACR next month, and we are already moving with urgency to bring afimetoran into pivotal development and to the people who need new effective options.”
The late-breaking oral presentation will feature data showing afimetoran met the trial’s primary endpoint, with a greater than 30 percentage-point difference in SRI-4 response versus placebo at all three doses evaluated (p<0.001). Afimetoran also showed improvements across secondary endpoints, including overall disease activity, skin and joint manifestations, corticosteroid reduction, and physician- and patient-reported outcomes. In addition, afimetoran demonstrated rapid and consistent activity in pharmacodynamic markers relevant to lupus pathobiology, including type I interferon (IFN), C3/C4, and anti-dsDNA antibodies. Afimetoran was generally well tolerated, with no new safety signals observed. The results show afimetoran reduces systemic and cutaneous disease activity in SLE and support afimetoran’s advancement into planned pivotal development in both SLE and cutaneous lupus erythematosus (CLE).
In addition, two preclinical posters will be presented highlighting afimetoran’s activity in animal models of lupus nephritis (LN) and rheumatoid arthritis (RA). These preclinical results further highlight afimetoran's mechanism of action and reinforce its ability to suppress key drivers of immune-mediated inflammation, potentially supporting its expansion into these indications for future clinical development.
Late-breaking oral presentation details:
Title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Afimetoran, an Oral, Once-Daily Equipotent TLR 7/8 Inhibitor, in Participants with Active Systemic Lupus Erythematosus
Abstract ID: LB23
Presenter: Kenneth C. Kalunian, M.D., Professor of Medicine in the Division of Rheumatology, Autoimmunity and Inflammation at the University of California, San Diego School of Medicine, and Director of the UC San Diego Lupus Center of Excellence
Session Date/Time: November 11, 2026, 9:00–9:15 AM EST
Additional afimetoran poster presentation details:
Title: TLR7/8 Blockade by BMS-905, a Structural Analog of Afimetoran, Drives Transcriptional Rewiring of Kidney Inflammation in a Mouse Model of SLE
Abstract ID: 0054
Session Date/Time: November 8, 2026, 10:30 AM–12:30 PM EST
Title: Afimetoran, an Oral Equipotent Dual Antagonist of Toll-Like Receptor 7 (TLR7) and TLR8, in Combination with an Anti-TNF Results in Increased Efficacy in a Collagen-Induced Arthritis Model
Abstract ID: 0079
Session Date/Time: November 8, 2026, 10:30 AM–12:30 PM EST
About the Phase 2 Study of Afimetoran in Systemic Lupus Erythematosus
The Phase 2 study (NCT04895696) is a global, double-blind, randomized, dose-ranging, placebo-controlled trial evaluating the efficacy, safety, and tolerability of investigational afimetoran in 248 adults with active systemic lupus erythematosus (SLE). The trial enrolled adults aged 18 to 70 years with active moderate-to-severe SLE despite ongoing background treatment. Participants were randomized 1:1:1:1 to receive once-daily oral afimetoran at 1 of 3 dose levels or placebo through Week 48, in addition to protocol-permitted background standard of care medications, including corticosteroids with a mandatory corticosteroid taper. The primary endpoint assessed SLE Responder Index-4 (SRI-4) response at Week 48. Secondary endpoints assessed measures of disease activity including low disease activity, skin and joint manifestations, corticosteroid reduction, physician global assessment, and quality of life.1
About Afimetoran
Afimetoran is an investigational selective, oral, once-daily, equipotent small-molecule inhibitor of Toll-like receptors 7 and 8 (TLR7 and TLR8), targets that play complementary and critical roles in lupus pathogenesis. Human genetics directly implicate TLR7 as a disease driver in lupus, while the biology of TLR8 contributes to pro-inflammatory cytokine production and immune responses, leading to potential progressive disease activity and irreversible organ damage.2-7 By blocking these components of the immune cascade, afimetoran has been shown to rapidly and substantially suppress signaling pathways in innate immune cells and B cells implicated in the pathology of various autoimmune diseases, including systemic and cutaneous lupus erythematosus.8-12 Afimetoran was a discovery by Bristol Myers Squibb’s researchers and was licensed to Beeline Medicines in July 2025. Afimetoran previously demonstrated exploratory efficacy in a Phase 1b study in cutaneous lupus erythematosus8 and was granted Fast Track designation by the U.S. Food and Drug Administration for systemic lupus erythematosus in May 2025.
About Lupus
Lupus encompasses a spectrum of chronic, heterogeneous autoimmune conditions marked by immune dysregulation, autoantibody production, and inflammation that can affect multiple organ systems.13 More than 5 million people worldwide live with a form of lupus, which disproportionately affects women of childbearing age (approximately 90% of people living with lupus are women) and individuals of Black, Hispanic, Asian, and Indigenous ancestry, in whom the disease tends to begin earlier, damage organs more rapidly, and lead to worse outcomes.13,14 Its principal forms, including systemic lupus erythematosus (SLE), cutaneous lupus erythematosus (CLE), and lupus nephritis (LN), which reflects renal involvement in SLE, may overlap along the disease continuum. Up to 85% of people with SLE develop cutaneous manifestations.15 While up to 25% of patients initially diagnosed with CLE may progress to SLE over time, not all patients presenting with CLE will develop systemic disease.15,16
SLE is the most common form of lupus and includes the most severe manifestations, characterized by multi-organ involvement and a relapsing-improving course of episodic flares that can cause cumulative, irreversible organ damage and significant morbidity.17,18 CLE comprises inflammatory skin conditions that can occur alone or alongside systemic disease, with lesions that range from localized to widespread and can lead to profound impact on quality of life and lasting scarring and dyspigmentation in discoid lupus.19,20 Despite recent advances, an urgent unmet need remains for well-tolerated, oral targeted therapies that deliver durable disease control with reduced steroid exposure.17,21
About Beeline Medicines
Beeline Medicines is a clinical-stage biotechnology company focused on developing and delivering category-leading precision therapies to transform the lives of people with autoimmune and inflammatory diseases. With a portfolio of potential best-in-class and first-in-disease therapeutic candidates that directly target key pathways governing dysregulated immunological and inflammatory responses, the Company is developing medicines that have the opportunity to provide durable, life-changing impact. Led by an established executive team and backed by world-class life science investors, each day Beeline Medicines is determined to bring the scientific rigor and operational excellence to get to what matters for patients – realizing a world where people with immune-mediated diseases can live life fully.
Beeline Medicines is headquartered in Stamford, Connecticut, with additional operations in Cambridge, Massachusetts, and Durham, North Carolina. For more information, visit www.BeelineMedicines.com and follow on LinkedIn.
Beeline Medicines Contact Information
Samantha Sandler
Head of Communications and Investor Relations
Media:
media@beelinemedicines.com
Investors:
investors@beelinemedicines.com
References
1 ClinicalTrials.gov. NCT04895696. Available at: https://clinicaltrials.gov/study/NCT04895696.
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