$SAB Biotherapeutics (SABS.US)$ NEWS FDA Provides Clearance ...
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FDA Provides Clearance to IND Application for Type 1 Diabetes Therapy SAB-142 by SAB Biotherapeutics
SAB Biotherapeutics (Nasdaq: SABS) announced that the FDA has cleared its IND application for SAB-142, a type 1 diabetes therapy, to proceed to a Phase 1 clinical trial in the US.
SAB-142, a human anti-thymocyte immunoglobulin (hIgG), aims to delay the onset or progression of type 1 diabetes. The ongoing HUMAN trial will assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of SAB-142 in both healthy volunteers and participants with type 1 diabetes.
The HUMAN trial is a randomized, double-blind, placebo-controlled, single-ascending dose study, with doses ranging from 0.03mg/kg to 2.5mg/kg. The trial design mimics the MELD-ATG study, whose topline results are expected in 2025.
The third cohort has been fully enrolled and dosed without observed serum sickness. This clearance marks a significant advancement in SAB's mission to slow disease progression in type 1 diabetes patients.
SAB-142, a human anti-thymocyte immunoglobulin (hIgG), aims to delay the onset or progression of type 1 diabetes. The ongoing HUMAN trial will assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of SAB-142 in both healthy volunteers and participants with type 1 diabetes.
The HUMAN trial is a randomized, double-blind, placebo-controlled, single-ascending dose study, with doses ranging from 0.03mg/kg to 2.5mg/kg. The trial design mimics the MELD-ATG study, whose topline results are expected in 2025.
The third cohort has been fully enrolled and dosed without observed serum sickness. This clearance marks a significant advancement in SAB's mission to slow disease progression in type 1 diabetes patients.
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