Approximately 110 participants enrolled in randomized, double-blind, placebo-controlled study; topline results expected in the second quarter of 2027
MIAMI, Oct. 7, 2026 /PRNewswire/ -- Resolve Therapeutics, a clinical-stage biopharmaceutical company developing non-immunosuppressive therapies for autoimmune diseases, today announced the completion of enrollment in its Phase 2 study of RSLV-132 in women with Sjögren's disease and moderate-to-severe symptom burden. The study enrolled approximately 110 participants at clinical sites across the United States.
The multicenter, randomized, double-blind, placebo-controlled, parallel-group study is evaluating RSLV-132 compared with placebo. The primary endpoint is the change from baseline at Day 169 in the cardinal symptoms of Sjögren's disease, as measured by the Sjögren's Symptom Activity Patient Reported Outcome instrument. Secondary assessments include fatigue, pharmacokinetics, immunogenicity, and safety.
Topline results are expected in the second quarter of 2027, following completion of participant follow-up and database review. The study is registered at ClinicalTrials.gov under identifier NCT06440525.
"Completing enrollment is an important milestone for the RSLV-132 program," said Gabor Illei, MD, PhD, Clinical Strategy Leader of Resolve Therapeutics. "We thank the participants, investigators, and clinical research teams whose commitment made this study possible. We look forward to completing follow-up and evaluating whether RSLV-132 can improve the symptoms that most impact Sjögren's patients."
About Sjögren's Disease
Sjögren's disease is a common systemic autoimmune disease that can cause dryness, fatigue, joint pain, and other manifestations. Available treatment options are very limited and used to manage individual symptoms or complications. There is currently no FDA-approved disease-modifying therapy for Sjögren's disease.
About RSLV-132
RSLV-132 is an RNase-Fc fusion protein composed of catalytically active human ribonuclease1 linked to an engineered human IgG1 Fc. The engineering of the Fc domain of the drug prevents its uptake into cells and gives it a three-week serum half-life. Cumulative safety data from five clinical trials demonstrate that RSLV-132 has an excellent safety profile. Furthermore, the drug is not immunogenic as anti-drug antibodies have not been observed in several clinical trials. RSLV-132 is the only non-immunosuppressive drug in development for Sjogren's. Importantly, it does not inhibit key components of the immune system which are required to enable the body to recognize and attack viral infections. The drug acts at the most proximal step in the inflammatory cascade and is designed to digest extracellular RNA and RNA bound to autoantibodies removing them from circulation thereby decreasing activation of the innate immune system and its attendant inflammation.
About Resolve Therapeutics
Resolve Therapeutics is a clinical-stage biopharmaceutical company developing non-immunosuppressive drugs to treat acute and chronic inflammation at its source, rather than blocking key downstream processes of the immune system. Its lead clinical program, RSLV-132, is being evaluated in Sjögren's disease. A Preclinical asset, RSLV-145 is being studies in ischemic stroke and subarachnoid hemorrhage. For more information, visit www.resolvetherapeutics.com.
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SOURCE Resolve Therapeutics, LLC
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