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Positive phase 3 efficacy and safety data were announced for a novel glucagon-like peptide-1 receptor agonist, polyethylene glycol loxenatide (PEX168). Researchers reported findings from two phase 3 studies of the drug at the 55th Annual Meeting of the European Association for the Study of Diabetes, held September 16 to 20, 2019, in Barcelona, Spain.
The randomized double-blind phase 3a trial examined PEX168 vs placebo in drug-naive patients with type 2 diabetes.1 After ≥8 weeks of controlled exercise and diet, patients with persistently poor glycemic control (N=406) were randomly assigned (1:1:1) to receive once-weekly injections of 100 or 200 µg of PEX168 or volume-matched placebo.
After 24 weeks of treatment, patients who received PEX168 had significant reductions in adjusted least-squares mean hemoglobin A1c (HbA1c) levels from baseline (PEX168 100 µg: -0.99%; PEX168 200 µg: -1.34%), while patients who received placebo had a nonsignificant reduction in HbA1c from baseline (-0.15%). The percentage of patients who achieved HbA1c <7.0% was also significantly higher in the groups that received PEX168 100 or 200 µg compared with those who received placebo (34.68% and 46.55% vs 15.7%, respectively).
The safety profile of PEX168 monotherapy was generally favorable. The most common adverse events were mild to moderate gastrointestinal reactions, including nausea and diarrhea. No serious adverse events or hypoglycemic episodes occurred during the trial.
Similar positive results were reported from a phase 3b trial investigating PEX168 as adjunct therapy to metformin.2 Patients with uncontrolled type 2 diabetes (N=533) who had received ≥8 weeks of metformin monotherapy (≥1500 mg/d) were enrolled to receive PEX168 100 µg, PEX168 200 µg, or placebo in addition to their metformin treatment.
After 24 weeks, reductions in HbA1c from baseline were significant for the groups that received metformin and PEX168 100 or 200 µg (-1.16% and -1.12%, respectively; P <.001 for both), but not for the group that received metformin and placebo (-0.36%). These reductions in HbA1c were sustained to week 52 of treatment with PEX168 100 and 200 µg. In a similar fashion to the phase 3a trial, no serious drug-related adverse events were reported during the trial, and gastrointestinal reactions were mild.
Overall, the phase 3 trials indicated that once-weekly treatment with PEX168 can improve glycemic control in patients with type 2 diabetes that is not managed by diet, exercise, or metformin alone, with a favorable safety profile.
Disclosure: These clinical trials were supported by Jiangsu Hansoh Pharmaceutical Group Co., Ltd., China.
References
1. Yang W, Ji Q, Shan Z, et al. Efficacy and safety of PEX168, a novel once-weekly GLP-1 RA, for monotherapy in patients with type 2 diabetes: a phase 3a study. Presented at: European Association for the Study of Diabetes 55th Annual Meeting; September 16-20, 2019; Barcelona, Spain. Abstract 761.
2. Jia W, Gao F, Lv X, et al. Efficacy and safety of once-weekly polyethylene glycol loxenatide (PEX168) combining with metformin in patients with type 2 diabetes: a phase 3b clinical trial. Presented at: European Association for the Study of Diabetes 55th Annual Meeting; September 16-20, 2019; Barcelona, Spain. Abstract 146.
