South Korea-based Hanmi Pharmaceutical will start Phase IIb clinical trials on its biologic drug, LAPS-Exendin4, for the treatment of patients with diabetes.
Around 700 patients with type 2 diabetes or obesity will be involved in the Phase II clinical trials, which will be carried out at some 150 centres in 12 different countries, including the US, Europe and Korea.
In the Phase II clinical trials, the company will evaluate the safety and efficacy of LAPS-Exendin4 by administering it once a week or once a month, while determining its dose in Phase III clinical studies.
The clinical trials are also designed to assess whether the drug is effective for controlling obesity.
Hanmi Pharmaceutical executive director Clinical Study Team Kang Ja-hoon said comparing to other GLP-1 class diabetic treatments that are already developed or are in development, LAPS-Exendin4 is expected to show the most excellent outcomes in lowering blood glucose and sustaining efficacy.
"The company will exert effort to successfully enter into phase III clinical study based on results of these clinical trials that are designed to comprehensively identify efficacies and safety of once a week or once a month administration, as well as obesity control," Ja-hoon said.
The company has also demonstrated safety and efficacy of the drug via its Phase I clinical trial carried out in South Korea and separate Phase II clinical trials conducted in the US and Europe.
The clinical trials carried out on LAPS-Exendin4 demonstrated that it provides the longest duration of effect compared to other treatments for type 2 diabetes patients.
It has also lowered HbA1c to less than target level in over 60% of subjects, proving its potentiality as a new GLP-1 class new drug for diabetes.
LAPS-Exendin, which is administered subcutaneously, is currently under development for the treatment of type 2 diabetes.