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Resolve Therapeutics Concludes Patient Enrollment for Sjögren’s Trial

Resolve Therapeutics Concludes Patient Enrollment for Sjögren’s Trial

With 110 participants now enrolled across the United States, Miami-based Resolve Therapeutics has reached a critical juncture in its Phase 2 study of RSLV-132. The trial targets women suffering from moderate-to-severe Sjögren’s disease, a chronic autoimmune condition currently lacking any FDA-approved disease-modifying therapies.

The multicenter, randomized, double-blind trial measures the drug’s efficacy against a placebo, focusing on shifts in cardinal symptoms by Day 169. Researchers are utilizing the Sjögren’s Symptom Activity Patient Reported Outcome instrument to quantify patient progress, while secondary assessments monitor fatigue levels, pharmacokinetics, and overall safety. The company expects to release topline results in the second quarter of 2027 following a rigorous database review.

RSLV-132 functions as an RNase-Fc fusion protein designed to digest extracellular RNA and RNA bound to autoantibodies. Unlike traditional treatments, this candidate is non-immunosuppressive, meaning it avoids inhibiting immune system components necessary for fighting viral infections. Gabor Illei, Clinical Strategy Leader at Resolve Therapeutics, noted that the milestone marks a significant step toward addressing symptoms that disproportionately impact patients' quality of life. The study is currently registered under identifier NCT06440525.

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