baminercept (BG 9924) / Biogen - LARVOL DELTA

The Sjögren's Tool for Assessing Response (STAR) demonstrates its ability to accurately detect treatment efficacy in 11 recent RCTs in Sjögren's disease (ACR Convergence 2025) - P2, P3 | "We conduscted this study to evaluate the performance of STAR in previously completed clinical trials shared within the NECESSITY consortium. Data from 9 trials used for STAR development (Abatacept (ASAP-III), leflunomide+hydroxychloroquine (REPURP-SS) and rituximab (TEARS and TRACTISS), the iscalimab and ianalumab phase 2 trials, Baminercept, hydroxychloroquine (JOQUER), tocilizumab (ETAP)) and two other independent clinical trials (GSK (NCT02631538), Belimumab + Rituximab, Belimumab, Rituximab versus placebo and BMS Abatacept (NCT02915159). In this analysis based on 11 trials, the STAR appears to detect treatment response accurately, with a high sensitivity to change for treatments showing a beneficial effect. Additionally, it exhibits specificity to change by not falsely detecting improvement in negative trials."

Clinical • Sjogren's Syndrome

An update of targeted therapeutic options for primary Sjögren syndrome: current status and future development. (PubMed, Expert Opin Pharmacother) - "Herein, the authors review the status of current targeted therapies and provide the reader with their expert opinion.Expert opinion: The progress in discovering novel treatments for pSS seem to be focused on searching new biological therapies as highly-selective drugs that can be effective without the adverse effects related to the wide, nonspecific immunosuppression induced by the drugs currently used. Most likely, the more disruptive therapeutic approach in pSS that could be seen in a few years is the use of combination strategies targeting different etiopathogenic pathways."

Journal • Immunology • Sjogren's Syndrome

Efficacy and safety of topical and systemic medications: a systematic literature review informing the EULAR recommendations for the management of Sjögren's syndrome. (PubMed, RMD Open) - "Ocular cyclosporine A was safe and effective in two RCTs including 1039 patients with dry eye syndrome...An RCT showed no significant placebo-differences for hydroxychloroquine 400 mg/day for the primary outcome (visual analogue scale (VAS) composite of dryness, fatigue and pain)...RCTs using infliximab, anakinra and baminercept found no placebo-differences for the primary outcomes. The two largest RCTs randomised 255 patients to receive rituximab or placebo and reported no significant results in the primary outcome (VAS composite), while prospective studies suggested efficacy in systemic disease. The current evidence supporting the use of the main topical therapeutic options of primary SjS is solid, while limited data from RCTs are available to guide systemic therapies."

Clinical • Journal • Review • Dry Eye Disease • Fatigue • Ophthalmology • Pain

IMMUNOSUPPRESSION FOR PRIMARY SJOGREN'S SYNDROME: A SYSTEMATIC REVIEW AND META-ANALYSIS (EULAR 2018) - "Table 1: Efficacy Outcome Measures Outcome # Trials Total # Trials showing statistical improvement Ocular dryness 22 1 of 1 Prednisone 1 of 2 Rituximab Oral dryness 22 1 of 3 Prednisone 1 of 3 Rituximab 1 of 3 DHEA Fatigue 14 1 of 4 Rituximab Tear production 19 0 Unstimulated saliva production 16 2 of 3 Rituximab 1 of 3 Interferon alpha Stimulated saliva production 14 2 of 4 Interferon alpha Quality of life  (mental component) 8 0 Quality of life (physical component) 8 0 ESSPRI 7 1 of 1 Iguratimod ESSDAI 6 1 of 1 Baminercept 1 of 1 Iguratimod ESR 14 1 of 1 Nandrolone 1 of 1 Prednisone 1 of 3 Hydroxychloroquine CRP 3 1 of 1 Hydroxychloroquine Meta-analyses of the above outcomes were performed at 6 months (Figure 1). Reducing immune activity and inflammation potentially improves salivary gland function. Subjective measures may be less helpful as sicca symptoms likely have subtle progression if trials span less than 1 year. Given that most trials were small, be

Retrospective data • Review • Immune Modulation • Immunology • Inflammation • Sjogren's Syndrome

Sjögren's syndrome: Old and new therapeutic targets. (PubMed, J Autoimmun) - "Biological agents previously implemented in successful therapeutic outcomes in rheumatoid arthritis (RA), such as anti-TNF agents, anakinra, tocilizumab and rituximab failed to reach primary outcomes in randomized double-blind controlled trials in the context of SS. Abatacept and belimumab, already licensed for the treatment of RA and lupus respectively, as well combination regimens of both rituximab and belimumab hold some promise in alleviation of SS-specific complaints, but data from large controlled trials are awaited...While targeting of cathepsin-S (Petesicatib), inducible costimulator of T cells ligand (prezalumab), and lymphotoxin beta receptor (baminercept) failed to fulfil the primary outcome measures, preliminary results from two randomized placebo controlled trials on CD40 blockade (Iscalimab) and B-cell activating factor receptor (Ianalumab) inhibition resulted in significant reduction of SS disease activity, with a favorable so far safety profile. Results..."

Journal • Review • CD40 • IL2

Efficacy and Safety of biological DMARDs modulating B cells in Primary Sjögren's syndrome: systematic review and meta-analysis. (PubMed, Joint Bone Spine) - "Our review shows that rituximab is not effective in pSS with the designs and outcomes proposed in the trials. Controlled randomised trials are needed to prove the efficacy of belimumab and epratuzumab in this indication. The randomised controlled trial evaluating baminercept failed to achieve its primary endpoint."

Journal • Retrospective data • Review

The Clinical Efficacy and Safety of Baminercept, a Lymphotoxin-β Receptor Fusion Protein, in Primary Sjögren's Syndrome: Results from a Randomized, Double-Blind, Placebo-Controlled Phase II Trial. (PubMed, Arthritis Rheumatol) - "In this trial, baminercept treatment failed to significantly improve glandular and extraglandular disease in patients with primary SS despite evidence from mechanistic studies that it blocked LTβR signaling."

Clinical • Journal • P2 data