Tuesday, June 25, 2013

Hanmi's long acting GLP-1 HM11260C demonstrates better GI tolerability

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 

Clinical data 

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


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