Kailera Therapeutics’ bridging study revealed over the weekend at the American Diabates Association Scientific Sessions provided evidence that the biotech’s lead obesity asset worked in a non-Asian population.
It’s a check the box moment, Chief Commercial Officer Jamie Coleman told BioSpace—one that could be seen as a run-of-the-mill update. But Kailera isn’t a run-of-the-mill company.
After exploding onto the scene about two years ago, Kailera headed into ADA fresh off the largest biotech IPO of all time. The company reeled in $625 million in April, enough to fund a pipeline of obesity assets from China’s Jiangsu Hengrui Pharmaceuticals.
“It was clearly a huge success,” said Coleman, who was part of the IPO roadshow team. “We celebrated. It was very exciting. . . . But at the end of the day, now we’re back to work, and we have to do it right.”
That Kailera broke records doesn’t really matter to what comes next, Coleman insisted. “You won’t hear [CEO Ron Renaud] talk about the biggest IPO. You won’t hear us talk about that. I think it’s really an important milestone, and we’re quite proud of it, but that’s not going to define our success.”
An underappreciated market
Coleman’s role at Kailera is a strong signal of what’s to come. She led the launch of Eli Lilly’s Zepbound brand, from the direct-to-consumer LillyDirect platform to making single-dose vials available, before jumping to Kailera in January 2025. She remembers that launch defying expectations at every turn.
“When I was leading Zepbound, to be honest, we didn’t have a lot of foresight at that time. It’s kind of obvious by Novo’s challenges, Lily’s challenges with supply and otherwise, that the opportunity was a bit under underappreciated,” Coleman said.
Underappreciated indeed. With both Novo and Lilly initially struggling to meet the unprecedented demand, compounding manufacturers rose up to serve patients—a problem both companies are still trying to fight.
“Every time we thought something, we were kind of wrong,” Coleman said. “It was always bigger than we thought it could be.”
Coleman arrived at Kailera with lessons learned from that launch, a renewed focus on delivering what patients want and a different kind of mission: build a commercial biotech.
“I’m not going to build Eli Lilly within the walls of Kailera,” Coleman said. “We can certainly think big and think aspirational and then find ways to do it in an efficient way that makes sense for our company.”
And that means finding the right patient segments to target. Like Kailera’s peers in the weight loss space, Coleman will have to contend with a fragmented market that is for now dominated by her alma mater and rival Novo Nordisk.
“The way you solve for fragmentation is finding a place where you can really win, and then you’ve narrowed your competitive set to who else is going after that same patient,” Coleman said.
For Kailera, that means patients seeking greater weight loss, perhaps more than tirzepatide can provide, rather than someone looking to fine-tune their body composition with longer dosing intervals. Kailera’s pipeline has been built out to cover many bases with that underlying theme.
After ADA, Kailera has plenty of data to come, particularly for lead asset ribupatide, a dual agonist of the GLP-1 and GIP receptors. A China-based Phase 2 study from Hengrui with a high dose will read out in 2027. Kailera is looking to take the therapy straight into late-stage global trials, pending the blessing of FDA officials, of course.
Coleman said the Kailera team is pretty confident the regulatory hurdles will be cleared, as “there’s some precedent for that.” And they have confidence in the translatability of the data given the ADA presentation.
In Kailera’s Phase 1 trial, participants of Asian and non-Asian descent received a single dose of injectable ribupatide and were followed for 29 days. Safety and tolerability were similar in both populations, with mostly mild gastrointestinal-related adverse events.
While the trial’s main goal was safety and tolerability, early indicators suggest that body weight was reduced in a dose dependent manner and there was no difference between the two populations. Weight was reduced by 1.4 to 5.5% in the low and high dose groups, respectively, compared to 0.4% for the group that received placebo.
“The bridging study is the first example showing we did not see [pharmacokinetic] differences between the two populations,” Coleman said.
Kailera is testing ribupatide in a global Phase 3 weight loss program called KaiNETIC featuring adults living with obesity or overweight, with key data expected in 2028.
The small biotech experience will be different, but Coleman is excited to work within a more flexible operation that can listen and adapt.
“My job is to figure out how do we leverage our small company mentality to compete with the big guys,” Coleman said. “I’m unlikely to go try to build a 1,500-person sales force like Eli Lilly’s, but I can probably get the bulk of the value through smarter targeting and AI driven approaches.”
https://www.biospace.com/business/ada-kailera-back-at-work-after-record-breaking-ipo-with-china-data-in-hand
