SAB Biotherapeutics Unveils Phase IIb SAB-142 Trial With C-peptide Endpoint Set for 2027
SAB Biotherapeutics outlined its fully human ATG candidate SAB-142 for newly diagnosed Type 1 diabetes, highlighting a global Phase IIb SAFEGUARD study enrolling patients ages 5–40 within 100 days of diagnosis with three dosing arms and a C-peptide endpoint in 2027. The company holds $140 million cash runway into 2028.
1. SAB-142 Profile and Mechanism
SAB-142 is a fully human anti-thymocyte globulin designed to avoid serum sickness and anti-drug antibodies associated with rabbit ATG. It aims to induce T-cell exhaustion while preserving regulatory T cells, supporting beta cell function and glycemic control in newly diagnosed Type 1 diabetes patients.
2. SAFEGUARD Phase IIb Trial Design
The global SAFEGUARD study targets Stage 3 patients diagnosed within 100 days, ages 5 to 40, across three arms (2.5 mg/kg, 1.5 mg/kg and placebo) with dosing every six months. The primary endpoint is one-year C-peptide preservation, with top-line data expected in the second half of 2027.
3. Regulatory and Commercial Strategy
The FDA has classified SAFEGUARD as a registrational pivotal trial, supporting a future BLA submission. Management cites a 64,000 annual U.S. Stage 3 diagnosis base and notes potential redosing to expand market reach, with early pricing benchmarks near $200,000.
4. Financial Position and Runway
SAB Biotherapeutics closed 2025 with $140 million in cash, fully funding the SAFEGUARD trial through top-line results and extending the runway into 2028. This funding supports ongoing development and preparatory commercialization planning.