Hualing Pharmaceutical-B (02552): The first patient in the US MAD Phase Ib trial of second-generation glucokinase activator (GKA) has been successfully administered

According to Zhitong Finance App, Hualing Pharmaceutical-B (02552) announced that the first patient has successfully administered the second-generation glucokinase activator (GKA) (HMS1005, previously known as HM-002-1005) in the multi-dose escalation (MAD) phase Ib trial conducted in the US. The study was a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetic characteristics and pharmacodynamic effects of multi-dose escalated HMS1005 in American subjects with type 2 diabetes (T2D). In this study, the mechanism and effects of HMS1005 will also be further investigated by evaluating PD markers (including blood sugar, insulin, C-peptide, GLP-1, glucagon, etc.) on an empty stomach and when eating, as well as monitoring blood sugar fluctuations through continuous glucose monitors (CGM).

HMS1005 is a novel molecular entity with improved physico-chemical properties. It is designed as a slow-release formulation to allow the medication to be taken once a day, bringing more convenience to patients and increasing the duration of the drug in the intestines, thereby enhancing the healing power of patients with insufficient GLP-1 secretion. Previously, the company had successfully completed and published the results of a single-dose escalation study of HMS1005 in the US to verify the feasibility of taking oral treatment once a day for T2D and obese patients.

Furthermore, after the successful completion of MAD Phase Ib research, the company plans to seek partners to develop HMS1005 for the global market.