1. SAB Biotherapeutics begins dosing in Phase 2b SAFEGUARD trial. 2. SAB-142 aims to modify progression of Stage 3 type 1 diabetes. 3. Strong clinical momentum is expected following earlier Phase 1 results. 4. Global trial enrollment includes U.S., Australia, and soon Europe. 5. Successful trial could position SAB-142 as a best-in-class treatment.
FAQ
Why Bullish?
The initiation of Phase 2b trials may increase investor confidence, similar to past biopharma advancements that spiked stock prices after trial milestones were met.
How important is it?
The ongoing trials and potential market impact of SAB-142 are crucial to SABS's growth trajectory, thus making the article highly relevant.
Why Long Term?
Results from ongoing trials could significantly influence market perception over the next few years, as similar scenarios have historically shown in the biotech sector.
SAB Biotherapeutics Doses First Patient in Phase 2b Clinical Trial for Type 1 Diabetes
MIAMI, December 18, 2025 (GLOBE NEWSWIRE) — SAB Biotherapeutics, Inc. (Nasdaq: SABS), a pioneering clinical-stage biopharmaceutical company, has announced the successful dosing of the first patient in its Phase 2b clinical trial, named SAFEGUARD. This landmark study aims to evaluate the safety and efficacy of SAB-142, a potential breakthrough treatment designed to modify the progression of stage 3 Type 1 diabetes (T1D).
Significance of the SAFEGUARD Trial
The SAFEGUARD trial, which stands for SAFety and Efficacy of human anti-thymocyte immunoGlobUlin SAB-142 ARresting progression of type 1 Diabetes, signifies a crucial step forward for SAB Biotherapeutics. As detailed by Dr. Alexandra Kropotova, Chief Medical Officer at SAB BIO, the initiation of this trial is pivotal in advancing their 'Beyond Insulin' vision. SAB-142 is a fully human biologic intended to selectively target immune cells involved in T1D while sparing others from damage, offering hope for a disease-modifying treatment.
Clinical Trial Details
The SAFEGUARD trial is structured as a double-arm, multi-center Phase 2b study, with ongoing participation from multiple international centers including the U.S., Australia, and New Zealand. Patients enrolled in the trial will receive two infusions of SAB-142 over six months. Following the completion of the study, all trial participants, including those in the placebo group, will have the opportunity to partake in a 12-month extension study.
- SAB-142: A novel immunotherapy aimed at treating autoimmune T1D.
- Study Parts:
- Part A: Dose-ranging study for adult patients.
- Part B: Randomized double-blind, placebo-controlled study.
- Enrollment: Ongoing at multiple global sites.
About SAB-142 and its Mechanism
SAB-142 is an innovative anti-thymocyte immunoglobulin (hATG) that aims to serve as a disease-modifying therapy for autoimmune type 1 diabetes. Its mechanism closely resembles that of rabbit ATG (rATG), which has been shown in clinical trials to slow disease progression in patients with new-onset stage 3 T1D. SAB-142 works by targeting and modulating pathogenic immune cells that compromise the function of pancreatic beta cells, thereby preserving insulin-producing abilities.
Company Background: SAB Biotherapeutics
SAB Biotherapeutics is at the forefront of developing high-potency human immunoglobulin G (hIgG) therapeutics to address immune and autoimmune disorders. With a strong focus on changing the treatment landscape for T1D, the company employs advanced genetic engineering methodologies to create therapeutic candidates that do not require human donors or convalescent plasma. The proprietary Tc-Bovine™ technology allows SAB BIO to produce an array of specifically targeted, high-potency hIgGs.
Looking Ahead
As this clinical trial progresses, SAB Biotherapeutics is set to provide further updates in 2026. The company remains committed to its goal of pioneering innovative solutions in diabetes care and is expected to share Phase 2b data by the second half of 2027.
Forward-Looking Statements
This announcement may contain forward-looking statements regarding the future performance of SAB Biotherapeutics. Such statements are inherently uncertain and can change based on various factors. Investors are reminded to review the risks outlined in SAB BIO's filings with the U.S. Securities and Exchange Commission.