Eli Lilly says weight-loss drug Zepbound proved effective as a treatment for sleep apnea

By Ciara Linnane

Investors cheered news amid hopes new indications could expand government coverage of costly drug

Eli Lilly & Co. said Wednesday that two late-stage trials evaluating a 10 mg or 15 mg injection of tirzepatide - the weight-loss drug marketed in the U.S. as Zepbound - reduced the severity of sleep apnea by up to nearly two-thirds in adults with obstructive sleep apnea (OSA) and obesity.

The news cheered investors, who sent the stock up 1.5%. If the drug can win approval for indications beyond weight loss, it has more chance of being covered by government programs such as Medicare.

The Phase 3 trials dubbed Surmount-OSA evaluated Zepbound in adults with moderate-to-severe OSA with the first trial involving patients who were not on positive airway pressure, or PAP, therapy for 52 weeks The second trial involved patients who were using PAP therapy.

The trials measured results using the apenea-hypopnea index, or AHI, compared with placebo, where AHI records the number of times a person's breathing shows a restricted or complete block of airflow per hour of sleep.

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The drug achieved a mean AHI reduction of up to 63% and met all primary and secondary endpoints in two Phase 3 trials. That meant about 30 fewer events per hour for patients in the second trial and 27 fewer for those in the first trial. There were 469 participants in the two trials, spread across the U.S., Australia, Brazil, China, Czechia, Germany, Japan, Mexico and Taiwan.

"Tirzepatide meaningfully improved sleep apnea symptoms in those with moderate-to-severe OSA and obesity with and without PAP therapy, and based on these results Lilly (LLY) plans to submit these data for global regulatory reviews," the company said in a statement.

Dr. David Song, investment partner at Tema exchange-traded funds, a suite of healthcare-focused ETFs, said the numbers look positive and that he will be hoping for an update when Lilly reports earnings later this month.

"Ultimately, we need more clarity on the details of the two data sets with regard to impacts on the medical device stocks (ResMed and Inspire Medical)," Song said in emailed comments.

ResMed and Inspire make products designed to treat OSA. ResMed's stock was down 6%.

"The data are solid enough that the overhangs on these stocks will remain," said Song.

Zepbound is the only approved GIP and GLP-1 treatment for chronic weight management and is marketed as Mounjaro outside of the U.S. Eli Lilly and Denmark's Novo Nordisk (NVO) (DK:NOVO.B) are currently market leaders in the weight-loss space and both have seen their stocks soar as the drugs have become highly popular.

The OSA trials found weight loss at 52 weeks for both studies was nearly 20% in a patient population that was about 70% male, who are known to achieve less weight loss with incretin therapy than females, said Lilly.

OSA is a sleep-breathing disorder that causes complete or partial collapse of the upper airway during sleep, which can impact oxygen saturation and cause people to wake up. It can have serious cardiometabolic complications for sufferers, who can end up with hypertension, heart disease, stroke, heart failure or Type 2 diabetes.

About 80 million adults in the U.S. suffer from OSA with more than 20 million of those living with moderate-to-severe OSA.

"However, 85% of OSA cases go undiagnosed and therefore untreated," said DR. Jeff Emmick, Ph.D., senior vice president, product development, at Lilly. "Addressing this unmet need head-on is critical, and while there are pharmaceutical treatments for the excessive sleepiness associated with OSA, tirzepatide has the potential to be the first pharmaceutical treatment for the underlying disease."

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The safety profile in both trials was similar to previous ones with the most common adverse events mild to moderate in severity. In the first trial, the most common adverse events were diarrhea, nausea and vomiting, while the second trial's most common adverse events were diarrhea, nausea and constipation.

Song noted that many people with OSA are obese or overweight.

"That should help with access when the company obtains label expansion in the OSA indication," he said.

Lilly's stock has gained 30% in the year to date, while the S&P 500 has gained 6%.

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-Ciara Linnane

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04-17-24 1401ET

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