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Resolve Therapeutics Completes Enrollment in Phase 2 Study of RSLV-132 in Sjögren's Disease

Resolve Therapeutics, a clinical-stage biopharmaceutical entity, has achieved a significant milestone by completing participant enrollment in its Phase 2 clinical trial of RSLV-132, targeting women suffering from Sjögren's disease with moderate to severe symptoms. This important advancement in research was announced on October 7, 2026, and the study was conducted across various clinical sites throughout the United States.

The trial is designed as a multicenter, randomized, double-blind, placebo-controlled study. Approximately 110 participants have been included and are being evaluated for their response to RSLV-132 compared to a placebo. The primary objective focuses on assessing changes from baseline at Day 169 concerning key symptoms associated with Sjögren's disease, utilizing the Sjögren's Symptom Activity Patient Reported Outcome (SSAPRO) instrument. In addition to the primary endpoint, secondary evaluations will consider factors such as fatigue levels, pharmacokinetics, immunogenicity, and overall safety of the treatment.

Results from this study are anticipated in the second quarter of 2027, following thorough participant follow-ups and database analysis. The trial is formally registered on ClinicalTrials.gov under the identifier NCT06440525.

Dr. Gabor Illei, Clinical Strategy Leader at Resolve Therapeutics, expressed gratitude to all participants, investigators, and research teams that contributed to reaching this stage, highlighting the crucial role they played in this endeavor. He stated, "Completing enrollment is an important milestone for the RSLV-132 program. We look forward to completing follow-up and evaluating whether RSLV-132 can improve the symptoms that most impact Sjögren's patients."

Understanding Sjögren's Disease

Sjögren's disease is a prevalent systemic autoimmune disorder that primarily leads to symptoms like dryness, fatigue, joint pain, and other complications. Current treatment options available are extremely limited and typically focus on managing specific symptoms rather than altering the underlying disease process. Notably, there are currently no FDA-approved therapies that can modify the disease's progression for Sjögren's patients.

RSLV-132: A New Hope for Patients

RSLV-132 is a unique therapeutic agent, classified as an RNase-Fc fusion protein, which combines a catalytically active human ribonuclease with an engineered human IgG1 Fc domain. This innovative design enhances the drug's stability and significantly extends its serum half-life to approximately three weeks.

The safety profile of RSLV-132 has been established through data gathered from five clinical trials, indicating an excellent safety record. Remarkably, there has been no evidence of immunogenicity, as anti-drug antibodies have not been detected in past studies. RSLV-132 stands out as the only non-immunosuppressive treatment currently under investigation for Sjögren's disease. It operates without inhibiting essential immune system functions necessary for combating viral infections. Instead, the drug targets the initial steps of the inflammatory process, specifically by degrading extracellular RNA and RNA bound to autoantibodies, which reduces the activation of the innate immune system and the resultant inflammatory response.

About Resolve Therapeutics

Resolve Therapeutics is committed to developing groundbreaking non-immunosuppressive therapies aimed at addressing acute and chronic inflammation at their source rather than inhibiting critical immune system processes. Their flagship clinical program, RSLV-132, is being specifically evaluated in the context of Sjögren's disease. Additionally, they have a preclinical candidate, RSLV-145, currently under investigation for applications in ischemic stroke and subarachnoid hemorrhage.

For more details about their research and clinical programs, visit www.resolvetherapeutics.com.