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Hanmi Pharmaceutical: Efpeglenatide (GLP-1 Analog), the Promising Potential for Anti-Diabetes/Anti-Obesity Treatment as Once Weekly up to Once Monthly

http://oliviawilliams035.soup.io On June 7, the interim result of a double blinded, randomized, 16 week

once a month treatment in T2DM (Study HM-EXC-204) and final result of a

double blinded, randomized 20 week treatment in obese patient without

diabetes (Study HM-EXC-205) were presented as poster.

SEOUL, South Korea--(BUSINESS WIRE)--Hanmi

Pharmaceutical Co., Ltd.(KSE: 128940) announced that they presented

5 clinical and non-clinical studies with 'efpeglenatide (LAPSCA-Exendin-4)'

at the 75th ADA Scientific Session being held June 6-8 in the Boston

Convention Center, USA.

On June 8, the final result of 12 week dose finding study in T2DM

patients with once weekly regimen (Study HM-EXC-203) was presented by

Study Principal Investigator, Dr. Julio Rosenstocko (Dallas Diabetes and

Endocrine Center, USA).

The study was a randomized, double blind for efpeglenatide groups or

partially open label for active control, liraglutide group. A total of

254 type 2 diabetes patients who were on stable metformin treatment or

treatment nave was allocated to 0.3mg, 1mg, 2mg, 3mg, and 4mg of

efpeglenatide, a placebo and liraglutide 1.8mg, respectively.

Ja-hoon Kang, Executive Director and Head of Clinical Development at

Hanmi Pharmaceutical stated "Current results are confirming the

potentials of efpeglenatide as a new treatment option for diabetes and

obesity. Also, we confirmed the potentials that efpeglenatide could be

developed with various regimen, once weekly up to once monthly without

formulation change. We will continue to explore the potentials of

efpeglenatide in our development program."

'Efpeglenatide' is a new GLP-1 analogue, applied with LAPSCOVERY.

This long acting delivery technology enables a peptide or protein to

extend its half-life from weekly to monthly.

In Study HM-EXC-205, a total of 297 obesity patients who do not have

diabetes were allocated at either once weekly regimen (4mg, 6mg) or

every other week regimen (6mg, 8mg). The body weight loss from baseline

were - 6.68kg and - 7.30kg in once-weekly 4mg and 6mg groups; - 6.67kg

and - 7.41kg in every other week 6mg and 8mg groups; and + 0.07kg in

placebo group, respectively.

Hanmi Pharmaceutical Co., Ltd.

In Study HM-EXC-204, efpeglenatide was treated as once-monthly in three

doses, 8mg, 12mg, and 16mg in 86 type 2 diabetes patients, who were on

stable metformin treatment or treatment naive. After 16 week treatment,

HbA1c was reached to below 7% and the patients achieving the target

HbA1c 7% was more than 60% in all efpeglenatide groups. The body weight

loss from baseline was observed as - 2.03kg, - 2.27kg, - 2.37kg and

0.86kg in the groups administered with 8mg, 12mg, 16mg and placebo,



After 12 week treatment, HbA1c changes were -1.41% and -1.61% at 3mg and

4mg of efpeglenatide ; - 1.38% at Liraglutide 1.8mg; -0.4% at Placebo,

respectively. The body weight loss from baseline were -2.66 kg and -3.47

kg at 3mg and 4mg of efpeglenatide ; -3.54 kg at Liraglutide 1.8mg;

-1.18 kg at Placebo, respectively.

Hanmi Pharmaceutical is a Korea-based global pharmaceutical company

focused on the development and commercialization of new pharmaceutical

products. The Company is fully integrated from R&D through

manufacturing, marketing and sales with an established presence in Korea

as well as China. The Company invests over 20 percent of its sales in

R&D and has over 20 programs in clinical development in three main

areas: 1) novel long-acting biologics based on the Company's LAPSCOVERY(TM)

platform including weekly insulin, weekly to monthly GLP-1, and their

combinations (Quantum Project) in diabetes and obesity; 2) novel

targeted agents https://en.wikipedia.org/wiki/Weight_loss against cancer and autoimmune disorders; and 3)

fixed-dose combination programs. More information on Hanmi is available

at www.hanmipharm.com.

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