Hanmi Pharmaceutical Announces Multinational Phase IIb Clinical Studies on LAPS-Exendin4, New Biological Drug for Diabetes
SEOUL, KOREA -- (Marketwired) -- 10/15/13 --
-- The clinical trial will be conducted by using the drug once a week or
once a month for patients with type2 diabetes.
-- It will be conducted at approximately 150 centers in 10 countries
starting in late September... it also seeks to find out effect on
Hanmi Pharmaceutical (KSE: 128940) will launch multinational phase IIb
clinical studies on its biologic drug for diabetes, LAPS-Exendin4,
aiming at administering once a week or once a month.
The company said on October 10 that the phase II clinical studies on
LAPS-Exendin4, which involve approximately 700 patients with type 2
diabetes or obesity, will be conducted at about 150 centers in a
dozen different countries, including the United States, Europe and
Korea, starting in late September this year.
The phase II clinical trials are designed to assess 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 studies are also designed to find out whether it is
effective for controlling obesity.
Executive Director Kang Ja-hoon, Clinical Study Team at Hanmi
Pharmaceutical 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," added she.
Meanwhile, Hanmi Pharmaceutical has demonstrated LAPS-Exendin4's
safety and efficacy through its phase I clinical study conducted in
Korea and separate phase II clinical studies conducted in the United
States and Europe.
Clinical studies on LAPS-Exendin4 conducted thus far showed that it
provides the longest duration of effect (half life is longer than 150
hours on average) compared to other treatments for patients with type
2 diabetes. And it lowered HbA1c to less than target level in more
than 60% of subjects, proving potentiality as an innovative GLP-1
class new drug for diabetes.
Note: LAPS-Exendin4 is a GLP-1 class drug for treating type 2
diabetes that accelerates secretion of insulin when glucose level is
elevated. As a new biologic drug combined with LAPSCOVERY, the
proprietary technology of Hanmi Pharmaceutical, that can drastically
prolong duration of drug effect, its administration interval is
extended to up to once a month.
Hanmi Pharmaceutical Co., Ltd.
Established in 1973, Hanmi
Pharmaceuticals (KSE: 128940) now is one of the top 5 pharmaceutical
companies in Korea, and has been the most R&D focused company with
the highest R&D investment for several years. Hanmi Pharm also has
worldwide offices in major countries such as China, Japan, Europe,
U.S etc. More detail about the company, visit
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