Date: 2015-06-08
Type of information: Presentation of results at a congress
phase: 2
Announcement: presentation of results at the American Diabetes Association Scientific Sessions in Boston, Massachusetts
Company: Hanmi Pharmaceutical (South Korea)
Product: efpeglenatide
Action
mechanism: Glucagon-like Peptide 1 (GLP-1) analogue/glucagon-like peptide-1 (GLP-1) receptor agonist/peptide. Efpeglenatide’ is a new GLP-1 analogue, applied with LAPSCOVERY. This long acting delivery technology enables a peptide or protein to extend its half-life from weekly to monthly.
Disease: type 2 diabetes
Therapeutic area: Metabolic diseases
Country:
Trial details:
Latest
news: * On June 8, 2015, Hanmi Pharmaceutical announced that they presented 5 clinical and non-clinical studies with ‘efpeglenatide (LAPSCA-Exendin-4)’ at the 75th ADA Scientific Session being held June 6-8 in the Boston Convention Center, USA. On June 7, the interim result of a double blinded, randomized, 16 week once a month treatment in T2DM (Study HM-EXC-204) and final result of a double blinded, randomized 20 week treatment in obese patient without diabetes (Study HM-EXC-205) were presented as poster. In Study HM-EXC-204, efpeglenatide was treated as once-monthly in three doses, 8mg, 12mg, and 16mg in 86 type 2 diabetes patients, who were on stable metformin treatment or treatment naive. After 16 week treatment, HbA1c was reached to below 7% and the patients achieving the target HbA1c 7% was more than 60% in all efpeglenatide groups. The body weight loss from baseline was observed as - 2.03kg, - 2.27kg, - 2.37kg and 0.86kg in the groups administered with 8mg, 12mg, 16mg and placebo, respectively. In Study HM-EXC-205, a total of 297 obesity patients who do not have diabetes were allocated at either once weekly regimen (4mg, 6mg) or every other week regimen (6mg, 8mg). The body weight loss from baseline were - 6.68kg and - 7.30kg in once-weekly 4mg and 6mg groups; - 6.67kg and - 7.41kg in every other week 6mg and 8mg groups; and + 0.07kg in placebo group, respectively. On June 8, the final result of 12 week dose finding study in T2DM patients with once weekly regimen (Study HM-EXC-203) was presented by Study Principal Investigator, Dr. Julio Rosenstocko (Dallas Diabetes and Endocrine Center, USA). The study was a randomized, double blind for efpeglenatide groups or partially open label for active control, liraglutide group. A total of 254 type 2 diabetes patients who were on stable metformin treatment or treatment naïve was allocated to 0.3mg, 1mg, 2mg, 3mg, and 4mg of efpeglenatide, a placebo and liraglutide 1.8mg, respectively. After 12 week treatment, HbA1c changes were -1.41% and -1.61% at 3mg and 4mg of efpeglenatide ; – 1.38% at Liraglutide 1.8mg; -0.4% at Placebo, respectively. The body weight loss from baseline were -2.66 kg and -3.47 kg at 3mg and 4mg of efpeglenatide ; -3.54 kg at Liraglutide 1.8mg; -1.18 kg at Placebo, respectively.
