Hanmi Pharm Presents Results of Follow-up Study to Phase 3 Clinical Trial on Efpeglenatide at AHA Conference


The results of a follow-up clinical study on efpeglenatide published in Circulation issued by the AHA (Courtesy of Hanmi Pharm)

Hanmi Pharm has presented the results of a follow-up clinical study on AMPLITUDE-O, a global Phase 3 clinical trial on efpeglenatide, a new drug candidate for diabetes, at the American Heart Association (AHA) Scientific Sessions.

The AHA Scientific Sessions were held in Boston, USA from November 11 to 13. The presentation on the follow-up study was led by Caroline Lam from the National Heart Center Singapore who in on the steering committee for the cardiovascular safety clinical study on efpeglenatide.

AMPLITUDE-O is a global Phase 3 clinical study on efpeglenatide. The study was conducted with 4,076 subjects with type 2 diabetes or cardiovascular disease in 344 regions in 28 countries.

The investigators in the follow-up study further analyzed AMPLITUDE-O to evaluate the effect of concomitant therapy using an SGLT-2 inhibitor and efpeglenatide.

It showed that efpeglenatide, a GLP-1 receptor agonist, improved cardiovascular risk regardless of the use of SGLT2 inhibitors.

The results showed that the efficacy and safety of efpeglenatide were not dependent on the use of SGLT-2 inhibitors. Efpeglenatide reduced major cardiovascular events (MACEs) by 26% and 30% in the group that was not administered SGLT-2 inhibitors and the group that was administered SGLT-2 inhibitors, respectively, and reduced expanded MACEs by 23% and 13%, respectively, compared to the control group.

The effectiveness of efeglenatide in reducing blood pressure, body weight, low-density cholesterol, and urine albumin/creatinine ratio were also not dependent on the concomitant use of SGLT-2 inhibitors. Side effects were also independent of the use of SGLT-2 inhibitors.

This study was chosen as a late breaker by the AHA for being groundbreaking. It was also published simultaneously in Circulation, a cardiovascular medical journal published by the AHA.

Hanmi Pharm CEO/President Kwon Se-chang said, “We have demonstrated that the therapeutic efficacy of efpeglenatide is not dependent on the concomitant use of SGLT-2 inhibitors, further enhancing the possibility of commercialization. [...] We will do our best to commercialize this first-in-class drug as soon as possible.”

Source: The Korea Economic Daily