Global clinical phase I trial of long acting basal insulin has been initiated with its optimized weekly new formulation.
Gwansun Lee, CEO of Hanmi Pharmaceutical recently announced in US that Hanmi is conducting clinical phase I trial of LAPSInsulin115 on 96 subjects with T1DM and T2DM.
Hanmi is going to investigate the single ascending dose of safety and tolerability, pharmacokinetics and pharmacodynamics of LAPSInsulin115 on 48 subjects with T1DM and 48 subjects with T2DM through the clinical trial.
LAPSInsulin115 is the newly developed weekly dosing long-acting insulin that has significantly longer half-life compared to existing LAPSInsulin. The pre-clinical trial result of LAPSInsulin115 was announced at ADA and EASD in 2014.
According to pre-clinical trial result, LAPSInsulin115 showed strong efficacy and long half-life, and it also demonstrated great combination therapy with GLP-1 analogue of LAPSCA-Exendin4 in terms of lowering glucose level and reducing body weight.
Jahoon Kang, senior director of clinical research and development department said that LAPSInsulin115 is expected to become an innovative candidate that can change the paradigm of pre-existing insulin therapy.
Meanwhile, Hanmi Pharmaceutical is currently leading Quantum Project including LAPSInsulin115, LAPSCA-Exendin4 and LAPSInsulin combo (combination product of LAPSInsulin115 and LAPSCA-Exendin4). Quantum Project is targeting diabetics and obesity market applying LAPSCOVERY technology for prominent efficacy and extended half-life.
By Lee Jae-seung
