SAB Biotherapeutics (SAB BIO) has announced the completion of Phase 1 enrollment for SAB-142, a human anti-thymocyte immunoglobulin (hIgG) being developed for delaying the onset or progression of type 1 diabetes (T1D). The company reported no observation of serum sickness in the enrolled healthy volunteers and T1D patients.
Clinical Trial Progress
The Phase 1 study aimed to establish the safety, tolerability, pharmacokinetic, and immunogenicity profile of SAB-142 in both healthy volunteers and patients with T1D. The target dose of 2.5mg/kg has been administered without any incidence of serum sickness. SAB anticipates releasing topline Phase 1 data by the end of 2024.
Path to Phase 2
Following the positive progress in Phase 1, SAB is preparing to initiate a Phase II SAFEGUARD study in 2025, focusing on patients with new-onset T1D. This trial will further evaluate the efficacy and safety of SAB-142 in slowing or preventing the progression of T1D.
Financial Status
SAB BIO's financial update indicates a solid position to support ongoing research and development activities. As of September 30, 2024, the company's cash, cash equivalents, and available-for-sale securities totaled $30.4 million. With the potential influx of funds from the exercise of outstanding Tranche B warrants, SAB projects sufficient cash to fund operations into 2026.
Executive Commentary
"This quarter we were pleased to report completed enrollment of SAB-142 Phase 1 study with no observed serum sickness," said Samuel J. Reich, chairman and CEO of SAB BIO. "Enthusiasm for SAB-142 continues to grow among clinical advisors and the T1D patient community as the program advances, and we are well-positioned and on schedule for initiating a Phase II study in 2025."
