Beeline Medicines Announces Positive Topline Results from Global Phase 2 Study of Afimetoran in Systemic Lupus Erythematosus

– Study met its primary endpoint, with afimetoran demonstrating higher SRI-4 response rates versus placebo at Week 48 (p-value <0.001 across all dose groups) –

– Secondary endpoints demonstrated improvements consistent with the primary endpoint findings –

– Afimetoran was generally well tolerated, with a safety profile consistent with previous Phase 1 clinical trial experience and no new safety signals observed –

– Results support advancement of afimetoran into pivotal development for both systemic and cutaneous lupus erythematosus –

STAMFORD, Conn., Sept. 09, 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 positive topline results from the global Phase 2 study of afimetoran in systemic lupus erythematosus (SLE). Afimetoran is an investigational selective, oral, once-daily, equipotent small-molecule inhibitor of Toll-like receptors 7 and 8 (TLR7 and TLR8).

The Phase 2 trial enrolled adults with active moderate-to-severe SLE and met its primary endpoint, with all three afimetoran dose groups demonstrating higher SLE Responder Index-4 (SRI-4) response rates at Week 48 compared with the placebo group (p-value <0.001 across all three dose groups). Secondary endpoints demonstrated improvements that were consistent with the primary endpoint findings and reinforced the overall efficacy profile. The safety and tolerability of afimetoran were generally consistent with previous Phase 1 clinical trial experience, and no new safety signals were observed. Detailed results from the study are expected to be presented at an upcoming medical congress.

“Too many people with systemic lupus continue to cycle through therapies that do not adequately control their disease, leaving them with diminished quality of life and vulnerable to debilitating long-term complications,” said Saqib Islam, Chief Executive Officer of Beeline Medicines. “These positive Phase 2 results strengthen our conviction that afimetoran has the potential to meaningfully change the treatment landscape as a foundational oral therapy for lupus patients. We look forward to advancing our program into pivotal development for those who urgently need new options.”

Afimetoran previously demonstrated exploratory efficacy in a Phase 1b study in cutaneous lupus erythematosus (CLE) and was granted Fast Track designation by the U.S. Food and Drug Administration for SLE in May 2025. The Company plans to advance afimetoran into pivotal development for both SLE and CLE.

“For people living with lupus, there is a significant need for effective, well-tolerated therapies that fit into everyday life,” said Nathalie Franchimont, M.D., Ph.D., Chief Medical Officer of Beeline Medicines. “Afimetoran’s clinically meaningful effects across measures of disease activity in this Phase 2 trial point to its potential to address both systemic and cutaneous manifestations and reinforce our belief in TLR7/8 inhibition as a mechanism uniquely suited to address a central driver of lupus biology. We are grateful to the participants, investigators, and their teams for their involvement in this study, as we work toward initiating our pivotal development program for afimetoran.”

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 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 rapidly and substantially suppresses 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, overlap along a 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. 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

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