Date: 2015-11-09
Type of information: Initiation of the trial
phase: 2a
Announcement: initiation of the trial
Company: PhaseBio Pharmaceuticals (USA - PA)
Product: PE0139
Action
mechanism: peptide hormone. PE0139 is a novel, super-long-acting basal insulin for the treatment of hyperglycemia associated with diabetes dosed as a once-weekly subcutaneous injection. PE0139 is a fully mature, native insulin molecule genetically fused to PhaseBio\'s elastin-like polypeptide biopolymer. A Phase 1 single ascending dose study of PE0139 in adults with type 2 diabetes demonstrated prolonged exposure to the drug that would enable once-weekly administration and a low peak-to-trough ratio. In nonclinical models of diabetes, PE0139 has demonstrated a flat PK curve with a long elimination phase and a reduction in blood glucose of significantly greater duration than with insulin glargine. In additional nonclinical studies, PE0139 demonstrated a strong synergistic action with PhaseBio\'s weekly GLP-1 receptor agonist PB1023.
Disease: type 2 diabetes mellitus
Therapeutic area: Metabolic diseases
Country: USA
Trial
details: This phase 2a study is a randomized, double-blind (Investigator and study subject), placebo controlled multiple dose sequential ascending dose study that will enroll up to 47 male and female subjects with type 2 diabetes mellitus (T2DM) in up to four cohorts. (NCT02581657)
Latest
news: * On November 9, 2015, PhaseBio Pharmaceuticals announced the initiation of a Phase 2a clinical study of PE0139, its novel, super-long-acting basal insulin for the treatment of hyperglycemia associated with diabetes dosed as a once-weekly subcutaneous injection. The multicenter, randomized, double-blind, placebo-controlled, multiple sequential ascending dose study will assess the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic response of PE0139 injection in adults with type 2 diabetes mellitus treating up to 50 subjects for six weeks.
