SAB BIO, (“SAB BIO”), a clinical-stage biopharmaceutical company with a novel immunotherapy platform that is developing human anti-thymocyte immunoglobulin (hIgG) for delaying the onset or progression of type 1 diabetes (T1D), today announced positive topline data from a Phase 1 trial of SAB-142 in a single-ascending dose among healthy volunteers. The study met its primary objectives related to safety and pharmacodynamic activity enabling SAB-142 to advance to Phase 2b clinical development.
“I am particularly excited with the analysis of the results of our Phase 1 trial, as it marks the successful achievement of another critical milestone for SAB-142,” stated Samuel J. Reich, Chairman and CEO of SAB BIO. “These data show clear and positive pharmacologic activity and strong safety profile for SAB-142, and underscore SAB-142’s potential to change the lives of people impacted by type 1 diabetes. With our initial study objectives met, we believe SAB-142 is now well-positioned to be a transformative therapy in autoimmunity by delaying the progression or onset of type 1 diabetes, and we look forward to advancing this product candidate into Phase 2b clinical development in 2025.”
Phase 1 trial summary data
The SAB-142 Phase 1 trial was designed as a randomized, double-blind, placebo-controlled, single-ascending dose, adaptive design clinical study among healthy volunteers and one cohort of participants with T1D. The objectives include establishing the safety, tolerability, pharmacokinetic (PK), immunogenicity and pharmacodynamic (PD) profile for SAB-142. The topline results reported today showed the following outcomes among healthy volunteer cohorts:
- Favorable safety profile: SAB-142 was generally well-tolerated and demonstrated a favorable safety profile that supports the chronic dosing of SAB-142 in an ambulatory setting.
- The SAB-142 Phase 1 dose range was between 0.03 mg/kg up to 2.5 mg/kg, which demonstrated favorable safety profile based on the 0% reported serum sickness and anti-drug antibodies.
- Sustained immunomodulation: SAB-142 demonstrated a clinically validated multi-target MOA with sustained immunomodulation.
- MoA analogous to rabbit ATG: The mechanism of action (MoA) of SAB-142 was shown to be analogous to rabbit ATG
- The SAB-142 MoA was shown to be analogous to rabbit ATG across multiple parameters correlative to C-peptide preservation.
Our topline data, which we plan to discuss in further detail at our webinar this morning, successfully demonstrates SAB-142’s impactful autoimmune response,”
Dr. Alexandra Kropotova, M.D., MBA, Executive Vice President and Chief Medical Officer, SAB BIO
“This is consistent with what we’ve seen preclinically, and we believe this validates SAB-142’s unique role as potentially the first and only fully human biologic with a validated and broad mechanism of action to enable outpatient dosing to delay the onset or progression of type 1 diabetes.”
Based on the data, SAB BIO plans to advance SAB-142 into a Phase 2b trial in 2025 to evaluate the therapeutic candidate in adult and pediatric patients with new-onset T1D.
Webinar details and registration information
Today’s webinar will feature presentations from SAB BIO’s management team and T1D Key Opinion Leader (KOL), Michael Haller, MD, the division chief of the Pediatric Endocrinology Division at the University of Florida and Silverstein Family Eminent Scholar Chair in Pediatric Endocrinology.
Date: Tuesday, January 28, 2025
Time: 8:00 a.m. ET
Register for the event here or join the conference call through the Events section of the SAB BIO Company website.
A live question and answer session will follow the formal presentations. A replay of the call will be available in the Presentation section of the SAB BIO Company website upon conclusion of the event.