Sonoma Biotherapeutics Announces Positive Interim Safety and Efficacy Data from Phase 1 REGULATE-RA Study of SBT-77-7101 in Refractory Rheumatoid Arthritis

Favorable early safety profile with preliminary clinical and mechanistic evidence of therapeutic activity in refractory rheumatoid arthritis

Data to be presented in a late-breaking oral presentation today 8:00 a.m. CT at the 2025 American College of Rheumatology (ACR) Convergence

Excerpt from the Press Release:

SOUTH SAN FRANCISCO, Calif. & SEATTLE–(BUSINESS WIRE)–Sonoma Biotherapeutics, Inc., a clinical-stage biotechnology company developing engineered regulatory T cell (Treg) therapies for autoimmune and inflammatory diseases,today announced interim safety and efficacy data from the Phase 1 Regulate-RA clinical trial. The results will be featured as a late-breaking oral presentation today at 8:00 a.m. CT at the 2025 American College of Rheumatology (ACR) Convergence, taking place in Chicago, IL.

“We are very encouraged by these positive interim results from a first-in-human study of our proprietary program SBT-77-7101 in patients with refractory rheumatoid arthritis (RA), a severe form of RA that persists despite treatment with multiple conventional, biologic, and targeted synthetic therapies,” said Jeff Bluestone, PhD, Chief Executive Officer and President. “The study is providing clinical and mechanistic evidence of therapeutic activity alongside emerging signs of durability and a favorable safety profile. We look forward to completion of the ongoing dose escalation of SBT-77-7101 and its advancement into the dose expansion phase.”

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