LLY.US (LLY.US) Foundayo, an oral weight loss medication, plans to treat sleep apnea with significant effects apply for FDA approval before the end of the year

The Zhitong Finance App learned that LLY.US (LLY.US) announced on Monday that Foundayo, an oral weight loss medication taken once a day, significantly reduced the severity of obstructive sleep apnea (OSA) in obese patients in late-stage clinical trials. Eli Lilly plans to submit an application to the US Food and Drug Administration (FDA) before the end of this year to seek approval for Foundayo's use in the treatment of moderate to severe obstructive sleep apnea in obese or overweight adult patients. As of press release, Eli Lilly's stock price had risen more than 3.4% to $1399.81.

This result means that Foundayo is expected to be another GLP-1 drug used to treat sleep apnea. The drug was marketed in the US in April of this year and is currently mainly used for weight management.

Obstructive sleep apnea is a common sleep-related breathing disorder. Patients experience repeated apnea or breathing weakness during sleep due to narrowing or obstruction of the upper respiratory tract, which may cause a drop in blood oxygen levels, increase blood pressure, and increase the risk of serious complications such as high blood pressure, heart failure, and stroke.

According to data from the US National Council on Aging, nearly 1 billion adults worldwide are affected by sleep apnea, including about 80 million people aged 20 and above in the US. Eli Lilly notes that most patients have yet to be diagnosed. Currently, treatment options for this disease are still limited. Many patients require positive airway pressure ventilation (PAP) devices to maintain normal breathing during sleep, but these devices are less convenient to use.

In December 2024, Eli Lilly's weight loss injection drug Zepbound became the first drug approved by the US FDA to treat obstructive sleep apnea. Today, Foundayo's positive trial results are expected to further expand Eli Lilly's product portfolio in this therapeutic field.

The clinical trial included two independent studies. The first study included 363 patients who were unable or unwilling to use PAP; the second study included 349 patients who had been treated with PAP for at least three months at the time of screening and continued to use the device during the trial. The patients in the Foundayo treatment group in both studies started with a lower dose and gradually increased the dose every four weeks.

The researchers mainly assessed treatment effects through the Apnea Hypoventilation Index (AHI). This indicator measures the number of times patients experience apnea or loss of breathing per hour during sleep, and is an important criterion for determining the severity of obstructive sleep apnea.

In the group of patients not using PAP devices, after 52 weeks of treatment with Foundayo, patients experienced an average reduction of 21.1 per hour of AHI incidents, compared to only 4.8 in the placebo group. The overall reduction in AHI in the foundayo treatment group was 43.8%, which was significantly better than the 6.3% reduction in the placebo group. Furthermore, 31.5% of Foundayo users in this group met the criteria for disease remission or improvement in severity to mild.

Foundayo also achieved positive results in the group of patients who continued to receive PAP treatment. The data showed that patients treated with Foundayo and PAP had an average reduction of 18.3 per hour AHI events after 52 weeks, while the placebo group had an average decrease of 5.5. The overall reduction in AHI in the Foundayo treatment group was about 27.5%, compared with only 3% in the placebo group. 19.6% of Foundayo users in this group met the criteria for remission or improvement to mild disease.

In addition to reducing apnea incidents, Foundayo also significantly improved patients' lack of oxygen during sleep. The test results showed that in patients not treated with PAP, Foundayo reduced the burden of lack of oxygen associated with sleep apnea by 55.9%; in patients who continued to use PAP devices, this indicator decreased by 45.8%. This index is mainly used to measure the extent and duration of the decrease in blood oxygen during a patient's sleep.

Additionally, Foundayo helped patients in the two studies achieve approximately 11% weight loss after 52 weeks and reduced levels of an inflammation-related biomarker.

In terms of safety, Eli Lilly said that Foundayo's safety and patient tolerability in this study were generally consistent with previous clinical trial results. The most common adverse effects mainly involve the gastrointestinal tract, including nausea, diarrhea, constipation, and vomiting, and are usually mild to moderate in severity.

Among patients not treated with PAP, approximately 12% of Foundayo users stopped treatment due to side effects, compared to 3.8% in the placebo group. Among patients treated with Foundayo and PAP, 6.8% discontinued due to side effects, which was higher than 0.6% in the placebo group.

Thomas Seck, senior vice president of product development at Eli Lilly's cardiovascular and metabolic health business, said that Foundayo has brought positive changes to obese patients. As the company plans to submit the latest test results to the FDA before the end of the year, it is expected to further help patients with sleep apnea in the future.

If finally approved, Foundayo is expected to provide new oral treatment options for adults who are obese or overweight and have moderate to severe obstructive sleep apnoea, while further strengthening Eli Lilly's competitive position in the obesity and related complications treatment market.