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Lilly's obesity portfolio in 'all-of-the-above mode'

2023-11-02

临床2期临床3期

Analysts tried to tease out any concerns Lilly may have on safety issues for orforglipron, the Indianapolis pharma’s next-gen oral GLP-1 agonist, and other late-stage obesity trials underway.

Eli Lilly is in “all-of-the-above mode” iLillysity, with the research teams morforglipront as possible to advance an oral candidateGLP-1build a portfolio of complementobesityatments.

Eli Lillyny is advancing the oral therapy oobesitypron, testing new doses for tirzepatide—known as Mounjaro as approved for diabetes—as well as preparing a slate of earlier stage candidates to further deepen the possible weight loss seen with the GLP-1 class. The sprawling obesity research program was the headline from Lilly’s third-quarter earnings call held Thursday.

Analysts tried to tease out any concerns Lorforgliprone on safety issues for otirzepatide, the IndiMounjaro pharma’s next-gediabetesLP-1 agonist, and other late-stage obesity trials underway. While the company brushed off concerns of liver toxicity last quarter in light of obesitys decision to drop an oral obesity candiLillyfor that reason, the questions still came fast and furious.

“We've invested quite a lot in those phasLillyrograms. They’re robust, cover orforglipronications, so there's no hesitation or trepGLP-1on there at all,” said Dan Skovobesity M.D., Ph.D., Lilly’s chief scientific and medical officer, as well as president of Lilly Research LPfizerories.

Asked why Lilly is testing higher doses of tirzepatide, a combo GLP-1 and GIP agonist, which is already approved for diabetes but is also awaiting an FDA decision in obesity, Skovronsky saLillye company believes they haven’t truly maximized dose response yetLilly Research Laboratoriese being tested in phase 2.

“We've hadLillygh patients on this drug fortirzepatideh that I expect the risk of uncovering a new safety signal withdiabetes marginally higher doses FDAextremely lowobesityt worried about that at all,” he said.

Skovronsky also urged investors not to pit one obesity program against the other in Lilly’s pipeline: “That’s not really the mindset in which we’re pursuing this.

“We see ourselves as a leader in the space and obesityunique opportunity. And our goLilly to exploit every single idea until we get data that says we shouldn’t,” Skovronsky said. “So high dose tirzepatide is just another version of that. But it doesn't have read-through to other things. We're just in all-the-above mode in obesity.”

One massive hurdle Lilly—and other key players in the space like Novo Nordisk—is going to have to overcome is treatment adherence. Data shows that patients must stay on GLP-1s to maintain weightirzepatidee they stop taking the injectable treatments, appetite comes back and weight returns.obesity

An analyst pointed Lillyhat long-term adherence is always an issuNovo Nordiskc conditions. But even without oral candidates ready, Lilly believes that patients will keepGLP-1sg tirzepatide to maintain their weight loss. That’s been the case with patients who have started on Mounjaro for diabetes, especially as compared to those who kept taking Lilly’s other diabetes med Trulicity.

Lilly does not yet have data to show the long-term adherence in obesity care, and president of Lilly's diabetes and obesity divisioLillye Mason noted that Novo’s Wegovy isn’t a great model either due to supply constraints that have restricted availability of the product for Mounjaro.diabetes Lilly diabetes

Lilly is going to tell,” said Mason on the call.obesity Lilly diabetes obesity

With many chronic conditions, patients can stop taking a drug without seeing acute issues or immediate return of symptoms. Mason doesn’t think that’s the case with tirzepatide judging by data seen in the phase 3 SURROUND trials.

“Consumers will feel their appetite increase and experience weight regain when they stop tirzepatide, so this should help reinforce treatment adherence,” Mason said. Lilly’s market research has shown that people who lose weight want to maintain it, he added.

What could help is an oral candidate like orforglipron. Skovronsky said the team is moving as fast as possible to advance the candidate, which is already in phase 3 tLillyg. But Lilly isn’t looking to have the oral option be just one thing. Orforglipron could be used alone as an initial treatment, for maintenance of weight loss or in combination.

The therapy spurred 14.7% weight loss at 3orforglipron phase 2 study published in the New England Journal of Medicine in June.Lilly Orforglipron

Lilly has another oral med called retatrutide, which was just shown in a phase 2 study to reduce weight by an average of 58 pounds at the end of 48 weeks, prompting the start of an expansive phase 3 program.