First Patient Dosed in SAB BIO's SAFEGUARD Clinical Trial of SAB-142 for the Treatment of Stage 3 T1D

Core Insights - SAB Biotherapeutics, Inc. has initiated dosing of the first patient in the Phase 2b SAFEGUARD clinical trial for SAB-142, a treatment aimed at delaying the progression of type 1 diabetes (T1D) [1][2] Company Overview - SAB Biotherapeutics is a clinical-stage biopharmaceutical company focused on developing human anti-thymocyte immunoglobulin (hATG) for T1D and other autoimmune diseases [1][5] - The company's lead candidate, SAB-142, is designed as a disease-modifying immunotherapeutic approach to treat stage 3 T1D [4][5] Clinical Trial Details - The SAFEGUARD trial is a double-arm, multi-center Phase 2b study assessing the safety, efficacy, and tolerability of SAB-142 in patients with stage 3 new onset T1D [3] - The trial consists of two parts: Part A is a dose-ranging study in adults, while Part B is a randomized double-blind, placebo-controlled study [3] - Patients will receive two SAB-142 infusions six months apart, with all participants eligible for a 12-month long-term extension study upon completion [3] Treatment Mechanism - SAB-142 is a multi-specific, fully human anti-thymocyte globulin that targets immune cells involved in the destruction of pancreatic beta cells, potentially preserving insulin-producing cells [4] - The treatment aims to modulate "bad acting" T-lymphocytes, such as cytotoxic T-cells, to prevent them from attacking beta cells [4] Future Outlook - The company is focused on rapid enrollment for the SAFEGUARD trial, with multiple sites activated globally, including in the U.S., Australia, and New Zealand [2][6] - SAB Biotherapeutics plans to share Phase 2b data in the second half of 2027 [6]