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Eli Lilly's (LLY) Tirzepatide Meets Goals in Sleep Apnea Studies

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Eli Lilly and Company (LLY - Free Report) announced that its pipeline candidate, tirzepatide, met all primary and key secondary endpoints in two phase III studies evaluating it in adults with obstructive sleep apnea (OSA) and obesity.

OSA is a common sleep-related breathing disorder that causes repeated interruptions in breathing during sleep. This can lead to decreased oxygen levels in the blood, causing strain on the cardiovascular system and other organs over time. It can lead to complications like hypertension, coronary heart disease, stroke, heart failure, atrial fibrillation and type II diabetes.

The SURMOUNT-OSA studies met the primary endpoints by showing that tirzepatide injection (10 mg or 15 mg) significantly reduced the apnea-hypopnea index (AHI) compared to placebo. AHI measures the number of times a person's breathing shows a restricted or complete block of airflow per hour of sleep and is used to evaluate the severity of OSA. Data from the SURMOUNT-OSA studies showed that treatment with tirzepatide resulted in a mean AHI reduction of up to 63%. This means tirzepatide has the potential to significantly improve the severity of OSA.

The first study evaluated tirzepatide in OSA patients who used breathing devices called positive airway pressure (PAP) for 52 weeks. These patients had 27.4 fewer sleep apnea events per hour on treatment with tirzepatide, compared to 4.8 event reductions for the placebo group. This means a mean AHI reduction of 55.0%

Patients who were on PAP therapy had 30.4 fewer events every hour compared to 6.0 events per hour for placebo. This means a mean AHI reduction of 62.8%. The weight loss observed across the two studies was nearly 20% at 52 weeks.

Eli Lilly’s stock has risen 101.7% in the past year compared with an increase of 13.8% for the industry.

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Based on data from these studies, Lilly plans to file regulatory application to the FDA and other regulatory bodies by mid-2024.

Tirzepatide, a dual GIP and GLP-1 receptor agonist (GIP/GLP-1 RA), is marketed by the name of Mounjaro for type II diabetes and as Zepbound for obesity by Lilly.

Zepbound was approved in November 2023 and launched in December. Mounjaro was approved in May 2022 for treating type II diabetes and generated impressive sales of $3.86 billion in 2023. Zepbound generated sales of $175.8 million in 2023.

The addition of OSA to tirzepatide’s label should significantly boost revenues as, at present, there are no drugs approved for treating OSA.

The GLP-1 segment is an important class of drugs for multiple cardiometabolic diseases and is gaining significant popularity. GLP-1 drugs work by mimicking the hormone GLP-1, resulting in weight loss, lowering hemoglobin A1c (HbA1c) and reducing cardiovascular risks. GLP-1 drugs are presently approved for treating type II diabetes and obesity. Lilly and Novo Nordisk are also evaluating their GLP-1 drugs for obesity-related diseases.

The GLP-1 segment is particularly attracting a lot of interest for the obesity indication. Other GLP-1 drugs that the FDA has approved are Novo Nordisk’s (NVO - Free Report) semaglutide medicines, Ozempic and Rybelsus, for type II diabetes and Wegovy for obesity.

Despite supply challenges, Wegovy is seeing strong prescription trends and is generating impressive revenues and profits for Novo Nordisk. Wegovy was approved by the FDA for lowering the risk of serious heart problems in obese/overweight adults in March.

Viking Therapeutics (VKTX - Free Report) also has a dual GLP-1/GIP receptor agonist called VK2735 in its pipeline. VK2735 is subcutaneously injected once weekly. Another key pipeline candidate is amycretin, a GLP-1 and amylin co-agonist, being developed as an oral pill for obesity. Viking Therapeutics’ amycretin showed faster weight loss than Novo Nordisk’s Wegovy in a phase I study. Viking Therapeutics also has an oral formulation of VK2735 in phase I development. Data from the phase I study, released in March, showed the oral tablet’s promising early weight loss and tolerability profile.

Amgen (AMGN - Free Report) also has an interesting GLP-1 receptor (GLP-1R) candidate in its pipeline called maridebart cafraglutide, which is being developed in phase II for obesity. Maridebart cafraglutide is an antibody-peptide conjugate that has a dual mechanism of action. It activates GLP-1R and inhibits the GIP receptor.

Amgen has another small-molecule obesity candidate in the pipeline called AMG-786, which is in phase I development. AMG 786 is not an incretin-based therapy and has a different target than maridebart cafraglutide.

Eli Lilly currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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