AstraZeneca has licensed ECC5004, an investigational oral once-daily glucagon-like peptide 1 receptor agonist (GLP-1RA), from Eccogene for the treatment of obesity, type 2 diabetes, and other cardiometabolic conditions. Eccogene will receive an initial upfront payment of $185M and up to $1.825B in future clinical, regulatory, and commercial milestones and tiered royalties.
Jingye Zhou, CEO of Eccogene, said: “GLP-1RA represents a very important class of drugs for multiple cardiometabolic diseases; currently there is no approved orally available small molecule GLP-1RA.”
GLP-1Ras have been shown to decrease hemoglobin A1c (HbA1c), promote weight loss, and reduce the risk of cardiovascular events. This is a breakthrough category of drugs originally targeted toward diabetics but now being used for weight loss too. The world market for anti-obesity drugs is estimated to be worth more than $37B over the next few years.
The competition in this burgeoning market is fierce. Just approved this week, Lilly’s Zepbound is the same formula as its type 2 diabetes drug Mounjaro. Since it was FDA approved in May 2022, Mounjaro has been used widely off-label to treat obesity. First out of the gate were Novo Nordisk’s Ozempic for diabetes and Wegovy for obesity (both semaglutide). Novo received FDA approval for these products in 2017 and 2021, respectively. All of these are injectables.
AstraZeneca is eager to be included in this new trend, but is seeking some way to be ahead of the pack.
Sharon Barr, executive vice president, biopharmaceuticals R&D at AstraZeneca, said, “Building on the promising Phase I clinical data generated by Eccogene, we believe this oral GLP-1RA molecule could offer alternatives to current injectable therapies both as a potential monotherapy as well as in combination for cardiometabolic diseases such as type 2 diabetes, as well as for obesity. ECC5004 further strengthens our existing pipeline addressing both incretin and non-incretin pathways, including our GLP-1/glucagon dual agonist [AZD9550] and long-acting amylin analogue [AZD6234].”
Preliminary results from a Phase I trial in the United States suggest ECC5004 has a different profile from most of the current drugs, with good tolerability and encouraging glucose and body weight reduction across the dose levels tested compared to placebo.
“With the number of people living with cardiometabolic conditions and obesity today already over one billion, there is a need for continued innovation and next generation therapeutic options,” said Barr.
Zhou added, “Small molecule GLP-1RAs, such as ECC5004, could potentially offer more dosing convenience and ease of use compared to existing GLP-1RA therapies.”
Under the agreement, AstraZeneca is granted exclusive global rights for the development and commercialization of ECC5004 for any indication in all territories except China, where Eccogene has the right to co-develop and co-commercialize in China alongside AstraZeneca.
Cardiovascular, renal and metabolism (CVRM), part of biopharmaceuticals, forms one of AstraZeneca’s main disease areas. AstraZeneca says it is investing in a portfolio of medicines for organ protection by slowing or stopping disease progression, and ultimately paving the way toward regenerative therapies.