Hanmi Pharmaceutical may no longer have a diabetes partner in Sanofi, but newly released results for its GLP-1 drug could move the needle for Type 2 diabetes patients with a history of cardiovascular disease, kidney disease or both. Efpeglenatide reduced the risk of heart attack, stroke and death and also slowed the decline in patients’ kidney function, new data show.
The treatment, once partnered with Sanofi, reduced the risk of nonfatal heart attack, nonfatal stroke or death from cardiovascular or undetermined causes by 27% compared to placebo. It also reduced the risk of kidney disease by 33%.
The data, from 4,076 patients, were presented virtually on Monday at the annual meeting of the American Diabetes Association (ADA).
Seven large trials have gauged the effects of GLP-1 receptor agonists on cardiovascular outcomes, but those studies have shown that this class of drugs curbs cardiovascular events in people who don’t have a history of heart disease, said the study’s lead investigator Hertzel Gerstein, M.D., in an ADA statement. Gerstein is a professor of medicine and Population Health Research Institute chair in diabetes research at McMaster University and Hamilton Health Sciences in Canada.
“This is a trial done in a different population and with a different sort of drug, efpeglenatide, which is an exendin-4-based GLP-1 receptor agonist, not a human-based one,” Gerstein said in the statement, referring to GLP-1 drugs based on an amino acid found in the saliva of the Gila monster. “Additionally, this trial recruited a particularly high-risk population of people who had either cardiovascular disease or renal disease, and a significant number had both.”
Trial participants had diabetes for an average of 15 years. The vast majority were taking glucose-lowering drugs (98%), and a large proportion also took cardiovascular drugs such as beta blockers (66%), statins (81%) and ARBs, ARNIs or ACE inhibitors (80%).
The study took place in 28 countries across five continents, and the participants were mostly male (67%) and white (87%).
Though the data could help doctors understand how efpeglenatide works in patients with heart and/or kidney disease, the future of efpeglenatide itself is uncertain.
Back in 2015, Sanofi bet €400 million ($435 million) upfront and promised €3.5 billion ($3.8 billion) in milestone payments to Hanmi in exchange for the worldwide rights to three diabetes treatments, including efpeglenatide. Four years later, the French pharma walked away from the GLP-1 med after Paul Hudson took over as CEO and ditched diabetes and cardiovascular R&D.
At the time, Sanofi said it would complete ongoing efpeglenatide studies and that it would look for a new partner to take over and commercialize the drug.
Meanwhile, several GLP-1 drugs have come to market since the FDA approved AstraZeneca’s exenatide, sold as Byetta, in 2005. These include Novo Nordisk’s semaglutide, sold in injectable and oral versions, as well as Eli Lilly’s dulaglutide, sold as Trulicity.
GlaxoSmithKline scored an FDA nod for albiglutide, sold as Tanzeum, in 2014, but decided to yank it from the market just three years later as it struggled to compete with Trulicity and Novo Nordisk’s liraglutide (Victoza).