Hanmi Pharmaceutical (CEO Lee Gwan-sun) is conducting Phase I clinical trials of LAPSInsulin115 with 96 patients suffering from type 1 and 2 diabetes.
In the clinical trials to be conducted in the U.S., the company will inject a single dose of LAPSInsulin115 in into 46 volunteers with type 1 or type 2 diabetes to test the safety and tolerance of the compound. It will also observe the time course of drug effects depending on the dosage.
LAPSInsulin115 is a new long-acting basal insulin developed by Hanmi Pharmaceutical. Also, it is an insulin treatment that made major improvements to half-life, and is optimized even more for weekly injections compared to existing LAPSInsulin.
The results of the pre-clinical trials of the treatment were announced at the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) last year.
In the pre-clinical trials, LAPSInsulin115 showed a higher efficacy to drop blood glucose levels and a longer duration of drug effects using only a low dose compared to existing insulin. Also, in a combined treatment with LAPSCA-Exendin4, a GLP-1 type new diabetes treatment aimed for once a month injections, it confirmed its efficacy in blood glucose control and body weight loss.
Meanwhile, Hanmi Pharmaceutical is also combining its innovative technology called LAPSCOVERY and conducting its Quantum Project, which consists of three innovative new drugs treating both obesity and diabetes - LAPSInsulin115, LAPSCA-Exendin4, and the combined form of the two treatments, LAPSInsulin combo. LAPSCOVERY, which is short for Long Acting Protein/Peptide Discovery, is a platform technology that prolongs the duration of drug effects and maximizes the treatment effect.