Miami, Florida, U.S., October 7, 2026
Resolve Therapeutics, a clinical-stage biopharmaceutical company developing non-immunosuppressive treatments for autoimmune diseases, has announced the completion of enrollment in its Phase 2 clinical study of RSLV-132 in Sjögren’s disease. The randomized, double-blind, placebo-controlled study enrolled approximately 110 participants across clinical sites in the United States, focusing on women with Sjögren’s disease experiencing a moderate-to-severe symptom burden. The trial is evaluating whether RSLV-132 can improve the symptoms that significantly affect patients’ daily lives. The company expects to report topline clinical results in the second quarter of 2027, following completion of participant follow-up and database review. This enrollment milestone advances the clinical development of RSLV-132, an investigational RNase-Fc fusion protein designed to target extracellular RNA associated with inflammatory processes without broadly suppressing immune function. The study will provide further information about the compound’s potential therapeutic activity, safety and tolerability in a disease for which treatment options remain limited.
Phase 2 Trial Evaluates RSLV-132 for Sjögren’s Symptoms
The Phase 2 study is a multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trial comparing RSLV-132 with placebo in women with Sjögren’s disease. Approximately 110 participants have been enrolled, and the study is designed to assess changes in disease-related symptoms over the treatment period. The primary endpoint measures the change from baseline at Day 169 in the cardinal symptoms of Sjögren’s disease, using the Sjögren’s Symptom Activity Patient Reported Outcome instrument. This assessment focuses on patient-reported experiences and provides a structured way to evaluate the impact of treatment on symptoms. Secondary assessments include fatigue, pharmacokinetics, immunogenicity and safety, helping investigators characterize the compound’s clinical performance and tolerability. The randomized and blinded study design is intended to support an objective comparison between the investigational therapy and placebo. With enrollment complete, the next stage involves participant follow-up, data collection and database review before the planned topline results in the second quarter of 2027. Resolve Therapeutics has highlighted the contributions of participants, investigators and clinical research teams in reaching this milestone. The forthcoming results will be important in determining whether the observed clinical outcomes support further development of RSLV-132 for this patient population.
RSLV-132 Targets Extracellular RNA Without Broad Immune Suppression
RSLV-132 is an investigational RNase-Fc fusion protein composed of catalytically active human ribonuclease linked to an engineered human immunoglobulin G1 (IgG1) Fc domain. The therapy is designed to digest extracellular RNA, including RNA associated with autoantibodies, with the aim of reducing activation of the innate immune system and the inflammation that follows. Unlike conventional approaches that broadly inhibit immune pathways, RSLV-132 is being developed to target an upstream component of the inflammatory process while preserving key immune functions. According to Resolve Therapeutics, engineering of the Fc domain is intended to prevent cellular uptake and provide a serum half-life of approximately three weeks. The company also reports that cumulative safety data from five clinical trials have demonstrated a favorable safety profile, with no anti-drug antibodies observed in several clinical studies. These findings are company-reported and do not establish the safety or efficacy of RSLV-132 for Sjögren’s disease; the ongoing Phase 2 study is intended to generate additional clinical evidence. If supported by further data, the approach could offer a differentiated strategy for managing autoimmune inflammation without broadly suppressing the immune system.
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Sjögren’s Disease Remains an Unmet Medical Need
Sjögren’s disease is a systemic autoimmune condition that can cause dryness, fatigue, joint pain and other symptoms affecting multiple parts of the body. The disease can substantially affect quality of life, and manifestations vary among patients. Current management primarily focuses on relieving individual symptoms and treating complications, while there is no FDA-approved disease-modifying therapy specifically for Sjögren’s disease. This treatment gap creates a need for approaches that address underlying inflammatory mechanisms and deliver meaningful improvements in symptoms and daily functioning. Resolve Therapeutics is developing non-immunosuppressive treatments intended to target inflammation at its source. RSLV-132 is its lead clinical program for Sjögren’s disease, while its preclinical candidate RSLV-145 is being investigated for potential applications in ischemic stroke and subarachnoid hemorrhage. The expected Phase 2 results in Q2 2027 will be a key milestone for RSLV-132, providing information on its clinical potential and helping guide subsequent development decisions. However, its effectiveness and potential role in treatment will depend on the outcomes of this and any future clinical studies.
Source: Resolve Therapeutics press release
