HM11260C developed by conjugating CA Exendin-4 (Exendin-4 analog) and the constant region of human immunoglobulin fragment via non peptidyl linker is intended to overcome the key limitations of exenatide (Byetta) injection. HM11260 c is intended for less frequent administration (once weekly or monthly) and better tolerability profile ( improved GI tolerability).
HM11260c safety, tolerability, PK and PD was evaluated in a double-blinded, randomized, placebo controlled phase IIa
study. HM11260 c was dosed repeatedly with weekly or monthly regimens in T2DM. HM11260C, a New Generation Long Acting GLP-1R Agonist With a Unique
Pharmacokinetic Profile Improves Glucose Control and GI Tolerability: A
Phase Iia Clinical Trial in Type 2 Diabetes Mellitus
Data through Day 57 from 48 patients in W1 (1 mg/wk), W2 (2 mg/wk), W3
(4 mg/wk), M1 (8 mg/mo) and M2 (12 mg/mo) are reported. Key demographics
were (active vs placebo; mean [SD]): age, 53.3 [7.0] vs 52.9 [8.7]
years; HbA1c, 8.4 [1.0] vs 8.1 [0.9] %. At Day 57, patients treated with
weekly regimens or monthly regimens experienced clinical significant
improvements from baseline HbA1c, fasting plasma glucose, body weight
compared with placebo. Most common AEs were nausea, vomiting and
diarrhea. Weekly regimen showed fewer GI AEs and most events were
reported after first injection. No treatment effect was observed on
vital signs, laboratory and ECG. HM11260C demonstrated meaningful
improvements in blood glucose control and good tolerability after
repeated treatment in all weekly and monthly cohorts
