Hanmi Pharm’s Study on New Drug for Diabetes Chosen as Late Breaker by AHA


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

Hanmi Pharmaceutical announced that the results of a follow-up study to the global Phase 3 clinical trial (AMPLITUDE-O) on efpeglenatide under development being as a new diabetes drug were presented at the 2021 American Heart Association (AHA) Scientific Sessions held in Boston, USA from November 11 to 13.

This presentation was led by Dr. Caroline Lam from the National Heart Center in Singapore who is on the steering committee for the clinical study, Effect of Efpeglenatide Cardiovascular Outcomes (CVOT).

The research team explained that a further analysis was conducted on the AMPLITUDE-O results, because, although both SGLT-2 inhibitors and GLP-1 receptor agonists are generally known to reduce cardiovascular events in patients with type 2 diabetes, the long-term effects of the drug combination had not yet been evaluated.

The follow-up study has shown that the efficacy and safety of efpeglenatide are independent of 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 efpeglenatide 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 and was also published simultaneously in Circulation, a cardiovascular medical journal published by the AHA.

Source: Aju Business Daily