Precigen’s (PGEN +0.8%) subsidiary Precigen ActoBio, has announced that its Phase 1b monotherapy portion of the ongoing Phase 1b/2a AG019 trial, has met the primary endpoint for the treatment of early-onset type 1 diabetes.
The study demonstrated safety and tolerability, with no safety signals were observed, and no patient discontinued treatment.
Eight-week treatment with AG019 monotherapy was safe and well-tolerated in daily dosages up to 6 x 1011 CFU (colony-forming units) in adult and adolescent patients.
Preliminary results demonstrated slower decline in C-peptide levels (biomarker for T1D disease progression) in 67% of adult patients in AG019 arm with 44% of these adult patients showing stabilization of mean four hours C-peptide area under the curve levels at six month
Phase 2a portion of the study is investigating safety and tolerability of AG019 in combination with teplizumab (PRV-031).
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