Eli Lilly's weight-loss drug Zepbound is effective in sleep apnea trials

Eli Lilly Its popular weight-loss drug Zibbond has shown potential in treating patients with the most common sleep-related breathing disorder in two late-stage clinical trials, the company said on Wednesday.

The preliminary results add to a long list of potential health benefits of weight loss and diabetes treatment, demand for which has risen dramatically over the past year despite their high prices and spotty insurance coverage.

Zepbound was more effective than placebo at reducing the severity of obstructive sleep apnea, or OSA, in obese patients after a year, according to preliminary data from both trials. The pharmaceutical giant said it plans to present the results at an upcoming medical conference and submit them to the US Food and Drug Administration and regulators in other countries in the middle of the year.

Eli Lilly previously announced that the FDA has granted Zepbound “Fast Track Designation” for patients with moderate to severe OSA and obesity. This classification expedites the review process for drugs that treat a serious or life-threatening condition and address unmet medical needs.

Eli Lilly shares rose 2% in early trading Wednesday.

These findings are an early sign of hope for the estimated 80 million patients in the United States who suffer from sleep apnea, which refers to interruption of breathing during sleep due to narrowing or blockage of the airways. About 20 million of these people have moderate to severe forms of the disease, but 85% of sleep apnea cases go undiagnosed, according to Eli Lilly.

Obstructive sleep apnea (OSA) can cause excessive daytime sleepiness and loud snoring and can contribute to serious complications, including high blood pressure, stroke, and heart failure. Patients with this condition have limited treatment options outside of cumbersome and often uncomfortable devices that provide positive airway pressure, or PAP, to allow normal breathing.

“Addressing this unmet need directly is critical, and although there are drug treatments for excessive sleepiness associated with sleep apnea, (Zepbound) has the potential to be the first drug treatment for the underlying disease,” Dr. Jeff Emick, of Eli Lilly. Senior Vice President of Product Development said in a statement on Wednesday.

Zepbound has slid into shortages since gaining approval in the United States for weight management in November. The active ingredient in Zepbound, known as tirzepatide, is also approved under the brand name Mounjaro for diabetes.

Mongaro and other diabetes medications are usually covered by insurance, while Zibbond and other weight loss medications are not. But the new data in sleep apnea patients gives Eli Lilly “a path to obtaining Medicare Part D coverage for Zepbound,” even before any changes in the federal program's coverage of obesity treatments, Chris Schott, a JPMorgan Chase analyst, wrote in a note. Wednesday.

Under new guidance last month, Medicare can cover some weight-loss drugs as long as they get FDA approval for an additional health benefit. Prescription drug plans run by private insurance companies, known as Part D, currently cannot cover these weight loss drugs alone.

Schott added that the new data gives Eli Lilly a path to increase Zepbound usage among men. He said the company noted that men may be more likely to use a drug called GLP-1 like Zepbound for sleep apnea than for obesity.

Eli Lilly's Zepbound works by mimicking two naturally produced gut hormones called GLP-1 and GIP. GLP helps reduce food intake and appetite. GIP, which also suppresses appetite, may also improve how the body breaks down sugar and fat.

Zepbound was tested in two phase 3 trials, both called SURMOUNT-OSA, in two groups of patients. It is worth noting that 70% of the study participants were men.

The researchers specifically examined how weekly injections affected what's called the apnea-hypopnea index, or AHI, which records the number of times per hour a person's breathing shows their airway is constricted or completely blocked. The index is used to evaluate the severity of obstructive sleep apnea and the effectiveness of treatments for this condition.

In both substudies, Zepbound was superior to placebo in reducing AHI, which was the primary goal of the trials.

The first study evaluated the drug in adults with moderate to severe obstructive sleep apnea and obesity who had not undergone PAP treatment.

People taking Zepbound had an average of 27.4 fewer AHI events per hour over 52 weeks, compared with an average reduction of 4.8 events per hour for placebo.

Zepbound also met the trial's second objective, resulting in an overall reduction in AHI of 55% compared to a 5% reduction in placebo.

The second study tested Zepbound in adults with the same conditions, but these patients were receiving treatment and planned to continue PAP treatment.

People taking Zepbound had an average of 30.4 fewer AHI events per hour over 52 weeks, compared with an average reduction of 6 events per hour for placebo.

Zepbound resulted in an overall reduction in AHI of approximately 63% compared with a reduction of more than 6% in placebo.

The results exceeded Wall Street expectations. Investors largely considered a 50% reduction to be the minimum for Eli Lilly's experiments to be considered successful. The nearly 60% improvement shows “tremendous benefits,” Deutsche Bank analyst James Chen wrote in a note on Wednesday.

In both studies, Zepbound helped patients lose about 20% of their weight. But Eli Lilly noted that men are known to achieve less weight loss than women who use treatments like Zipbond.

In a note on Wednesday, Terrence Flynn, an analyst at Morgan Stanley, called this weight reduction encouraging and said the company expects a 15% to 18% weight loss in the trial. Morgan Stanley views “this as another positive data point supporting the efficacy profile of terzepatide,” Flynn said.

It is worth noting that Eli Lilly's main competitor Novo Nordisk Weight loss and diabetes medications have not been studied in patients with sleep apnea.