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 to be a disease-modifying immunotherapy that targets multiple immune cells involved in T1D without necessarily killing them [2][4] 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] Development and Future Plans - The company is focused on rapid enrollment in 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]