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ARTICLE | Clinical News

TOL-3021: Phase II data

July 1, 2013 7:00 AM UTC

A blinded, dose-escalation Phase II trial in 80 adult Type I diabetics showed that all doses of once-weekly intramuscular TOL-3021 for 12 weeks improved C-peptide levels, a marker of pancreatic beta cell function, relative to placebo. Specifically, the 1 mg dose of TOL-3021 for 12 weeks led to a significant 19.5% increase in C-peptide levels from baseline to week 15 vs. an 8.8% reduction for placebo (p<0.026). TOL-3021 also significantly reduced the number of proinsulin-reactive CD8 T cells vs. placebo (p<0.006) without affecting T cells against unrelated islet or foreign molecules. Additionally, TOL-3021 led to no significant changes in interferon (IFN) gamma, IL-4 or IL-10 production in CD4 T cells. Mean HbA1c was relatively stable at baseline and at 15 weeks in all TOL-3021 treatment groups. TOL-3021 was well tolerated with no serious adverse events reported. Patients received placebo or 0.3, 1, 3 or 6 mg TOL-3021 for 12 weeks. Data were published in Science Translational Medicine. ...