PB1023 for Type 2 Diabetes
PB1023 is a recombinant GLP-1 analogue genetically fused to PhaseBio’s ELP biopolymer to be used as a once-weekly treatment for hyperglycemia associated with type 2 diabetes. In a phase 2a multiple ascending dose study, PB1023 demonstrated a prolonged effect on glucose control, which was maintained between weekly doses of the drug.
PhaseBio subsequently conducted a multi-center phase 2b study in approximately 600 patients over 20 weeks to compare several doses of PB1023 against placebo and against an active comparator, Victoza® (liraglutide, Novo Nordisk). PB1023 was administered once per week, whereas Victoza® must be administered daily. Although PB1023 showed a significant reduction in HbA1c compared to placebo, the reduction was less than that seen with Victoza®. There were no serious adverse events in the PB1023 treatment group, no evidence of an adverse cardiovascular safety signal and no neutralizing antibodies were detected (approximately 300 patients were treated with PB1023).
PB1023 and PhaseBio’s basal insulin, PE0139, have demonstrated a strong synergistic effect in animal models of type 2 diabetes, returning the db/db mice to a near-normal glucose response. PhaseBio is evaluating future clinical studies to examine the efficacy of PB1023 co-formulated with PE0139.