On Tuesday, SAB BIO (NASDAQ:SABS) released topline data from a Phase 1 trial of SAB-142 in a single-ascending dose among healthy volunteers.
The study met its primary safety and pharmacodynamic activity objectives, enabling SAB-142 to advance to Phase 2b clinical development.
- Favorable Safety Profile: SAB-142 was generally well-tolerated and demonstrated a favorable safety profile that supports its chronic dosing in an ambulatory setting.
- The SAB-142 Phase 1 dose range was between 0.03mg/kg and 2.5mg/kg, which demonstrated a 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.
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 type 1 diabetes (T1D).
In November 2023, the company announced that the first HUMAN trial participants had been dosed in Australia.
This Phase 1 randomized, double-blind, placebo-controlled, single-ascending dose, adaptive design clinical study was designed to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenous SAB-142 in healthy volunteers and participants with T1D.
Price Action: SABS stock is down 50.2% at $2.17 at last check Tuesday.
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