Hanmi’s Efpeglenatide reduces cardiovascular risk

The results of the Efpeglenatide study were published

Proof of cardiovascular and kidney disease safety in a study of 4,076 people

Sanofi announced a study that reduces the risk of cardiovascular and kidney disease of new diabetes drugs that have returned rights to Hanmi.

 

Hanmi plans to find new opportunities based on research results.

 

According to Hanmi on the 29th, Sanofi held an independent session for Efpeglenatide at the American Diabetes Association (ADA) and announced the results of AMPLITUDE-O on eight subjects through eight researchers for two hours.

 

Efpeglenatide is a GLP-1 family of diabetes drugs that Hanmi transferred technology to Sanofi in November 2015.

 

It is a new bio-drug that extends daily injections from once a week to up to once a month.

 

Sanofi conducts five clinical trials of Efpeglenatide.

 

It finally gave back its rights to Hanmi in September last year.

 

The findings released by Sanofi this time were conducted on more than 4,000 patients, the most among five clinical trials.

 

AMPLITUDE-O Phase 3 clinical trials were given weekly Efpeglenatide or placebo to 4,076 patients with type 2 diabetes or cardiovascular disease in 344 regions in 28 countries.

 

In type 2 diabetes patients, the risk of cardiovascular and kidney disease was significantly reduced when administered in two doses, Efpeglenatide 4mg and Efpeglenatide 6mg.

 

The incidence of major cardiovascular diseases in the Efpeglenatide group compared to the placebo group decreased statistically to 27% and 32% in kidney disease.

 

Professor Naveed Sattar of the University of Glasgow said, "The AMPLITUDE-O clinical trial safely reduced the incidence of major cardiovascular and kidney disease in low-risk and high-risk patients with type 2 diabetes."

Major speakers and topics of the independent session for Efpeglenatide conducted by Sanofi (data: Hanmi)

"Efpeglenatide has prepared a new opportunity to create another innovation," said Baek Seung-jae, executive vice president of Hanmi Pharmaceutical.

 

"We are focusing our company's capabilities on expanding and materializing the potential of Efpeglenatide, which has been proven through large-scale global clinical trials," he expected.

 

Another global clinical phase 3 (AMPLITUDE-M) result of Efpeglenatide, which was conducted on 406 type 2 diabetes patients whose blood sugar is not controlled by diet and exercise, was also introduced by Dr.

 

Juan Frias, a leading researcher.

 

The clinical trial, which was conducted with double blindness, divided Efpeglenatide into three dose groups (2mg, 4mg, and 6mg) for 56 weeks, compared Glycated hemoglobin with primary evaluation variables for 30 weeks, weight loss, and safety for 56 weeks.

 

Studies have confirmed excellent blood sugar control and weight loss effects when Efpeglenatide is administered to type 2 diabetes patients.

 

Treatment also remained stable for long periods of time.

 

Glycated hemoglobin showed statistically superior improvements in all doses over placebo in Week 30 of treatment.

 

Shortly after the announcement, the New England Journal of Medicine (NEJM) published a paper on Efpeglenatide.

 

"Cardiovascular safety is an important factor that doubles the global competitiveness of drugs in large-scale clinical trials, allowing us to create other innovations and business opportunities," said Kwon Se-chang, CEO of Hanmi Pharmaceutical.

 

Main screen of the New England Journal of Medicine (NEJM) introduced Efpeglenatide (reference: Hanmi)