Medical Innovation Exchange

Next-gen Lilly obesity drug secures phase 3 win as Innovent readies Chinese approval push

Innovent is gearing up to push into the China obesity market as the company announces a phase 3 win for mazdutide, a molecule from Eli Lilly’s deep bench of obesity assets.

China-based Innovent secured the rights to the dual GLP-1/glucagon receptor agonist from Lilly in 2019 for an undisclosed sum. A phase 2 readout in May raised expectations, linking a 9 mg dose of the molecule to placebo-adjusted weight loss of 15.4% after 24 weeks.

Now, the company has published results that it has claimed show the drug is “the first GLP-1R/GCGR dual agonist succeeding in phase 3 trials.” A total of 610 participants received either 4 mg or 6 mg dose of mazdutide or placebo during the 48 week study.

The trial, dubbed GLORY-1, hit both of its primary endpoints, showing superiority to placebo when it came to reducing body weight by week 32 as well as the proportion of participants with a weight loss of 5% or more. The “weight-loss efficacy was further improved from week 32 to week 48,” the company noted.

The trial also aced its secondary endpoints, which included the proportion of participants who saw a weight loss of 10% and above, alongside changes in waist circumference, systolic blood pressure, triglycerides and low-density lipoprotein cholesterol, to name a few. “Mazdutide demonstrated superiority to placebo in all the above weight loss and cardiometabolic endpoints,” Innovent said.

The drug’s safety profile was similar to its previous trials and no new safety signals were observed. The company didn’t offer a deeper look at its efficacy data in the release—although it did reference plans to publish the full results in the future—but Innovent sounded confident it has what it needs to pitch to Chinese regulators.

“The results of the GLORY-1 study show that mazdutide has strong weight loss efficacy with favorable safety and tolerability,” Lei Qian, Vice President of Clinical Development at Innovent, said in the Jan. 8 release.

“We are further preparing the results and plan to submit the first NDA of mazdutide for weight management in the near term,” he added. “We are also developing mazdutide for other indications on the basis of scientific evidence and unmet medical needs. Innovent will continue to strategically build our next-generation product pipeline in the cardiovascular and metabolic field, and help people’s pursuit of a healthy life.”

While GLORY-1 is focused on 4 mg and 6 mg doses, Innovent has also just launched another phase 3 obesity study called GLORY-2 that is assessing a 9 mg dose. This dose level was identified in the phase 2 update back in the spring as being “favorable.”

Innovent isn’t the only one eyeing up the 160 million-strong obesity market in China. Lilly completed a China phase 3 trial of tirzepatide—now sold as Mounjaro in the U.S. for diabetes and as Zepbound for obesity—in late 2022. Meanwhile, Novo Nordisk won a China approval for semaglutide in 2021, although, with the authorization only covering diabetes, use in obesity is just off-label in the country for now.

Lilly has the rights to develop mazdutide outside of China and continues to list the candidate in its phase 1 pipeline. However, with tirzepatide setting the bar high—weight loss after 24 weeks was similar to Innovent’s phase 2 results—and mazdutide one of two next-generation weight loss products in Lilly’s pipeline, it is unclear how far the Big Pharma will take the program.

https://www.fiercebiotech.com/biotech/next-gen-lilly-obesity-drug-secures-first-phase-3-win-innovent-readies-chinese-approval

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