Sleep apnea relief in a pill: apnimed drug phase 3 data internship for the submission of the FDA

The standard treatment of respiratory problems caused by obstructive sleep apnea is a medical device. But many people find it uncomfortable to wear the mask that comes with a continuous positive respiratory pressure machine (CPAP). Apnimed’s experimental medication could provide an easier alternative, and this pill now has the results of a pivotal study The startup indicates that support plans for submission of the FDA. This could end up challenging a large pharmaceutical giant.

Apnimed’s approach to obstructive sleep apnea (OSA) is to target the muscles that you probably did not realize. The condition, which affects around 80 million people in the United States, leads to a repeated collapse of the upper respiratory tract during sleep, causing respiratory interruptions and intermittent oxygen deprivation periods. Anatomical anomalies contribute and surgery offers a means (although, invasive) to approach the condition. Another contributor to AOS is the malfunction of the muscles that control the airways.

The drug APNIMED, AD109, combines two compounds: the new antimuscarinic molecule of the company called Aroxybutynine, and the old drug disorder / attention hyperactivity (Strattera brand brand). This couple is formulated in a single pill taken every night before bed. According to Cambridge, ApniMed made from Massachusetts, the synergistic effect of the two pharmaceutical ingredients of AD109 targets the neurological tracks to activate the muscles in the upper respiratory tract to keep it open during sleep. The AD109 came from a discovery of a Brigham & Women’s Hospital (BWH) hospital that this combination was effective in treating AOS, said the APNIMED co-founder and CEO Larry Miller. This discovery aligned itself on previous research suggesting that these classes of drugs can adjust activity in the part of the brain which controls the upper muscles of the respiratory tract.

“In the first studies of BWH where electrodes were placed in the language muscle during sleep, the researchers were able to directly show that these classes of drugs can increase muscle tone in the upper respiratory tract and reduce obstructions of the respiratory tract,” said Miller.

The results of the trial announced on Monday come from a phase 3 test which scored 646 adults in the United States and Canada who have a light, moderate or severe OSA and cannot tolerate CPAP therapy or refuse it. Participants were randomly assigned to receive the study medication or a placebo to take every evening. The main objective was to measure the change in the apnee-hypopnea index at six months, a scale used to measure reductions or respiratory interruptions during sleep (the higher the score, the more serious the AOS).

APNIMED reported an average reduction of 55.6% of the scores of the Apnea-hypopnea index in the study arm of the study as well as “considerably improved oxygenation and a reduced gravity of the disease”. For the placebo arm, the average reduction in scores was 19%. The company said that AD109 was generally well tolerated and that adverse events were in accordance with previous tests. The most common adverse events reported in a four -week phase 2 study were the dry mouth, insomnia and urinary hesitation.

Apnimed said that the full results of phase 3 will be presented at a medical meeting later this year and published in a review evaluated by peers. The AD109 development program includes a second phase 3 trial testing the drug in patients with AOS for a year. Apnimed is expecting preliminary data in this study in the third quarter of 2025. With data from the two studies, the company provides for a submission of the FDA for AD109 at the beginning of 2026. Miller noted that AOS affects more than a billion people worldwide. APNIMED plans to explore the means to make available to these AD109 patients, he said.

A sleep apnea medication is already available in the United States at the end of last year, the Obesity Medication of Eli Lilly, Zepbound, has expanded its label, becoming the first drug approved by the FDA for moderate to severe AOS. The injectable peptide once a week is designed to bind to two intestinal receptors to trigger metabolic effects, such as weight loss. The way Zepbound works to treat AOS is unknown, but obesity is a risk factor for disorder. The results of Zepbound Osa’s trials have shown that patients have lost weight. It is believed that this reduction in weight improves sleep apnea.

Despite being the first medication to market AOS, Zepbounds are facing obstacles in this indication. The manufacture of peptide drugs is expensive. In addition, many patients prefer injections. As a small molecule, AD109 is cheaper to manufacture and will be available as a pill more suited to patients. But Apnimed is not the only company to develop oral drugs from AOS.

Incannex health care has reached phase 2/3 tests with IHL-42X, a combination of two older drugs: acetazolamide, which is an inhibitor of the carbon dioxide whose uses approved by the FDA include glaucoma and epilepsy, dronabinol, a loss of synthetic cannabinoid to treat nausea, vomiting and loss of call. In addition, the two drugs have clinical data showing reductions in the apnea hypopnea. The company believes that Dronabinol’s activity on cannabinoid receivers causes the respiratory tract. Meanwhile, acetazolamide signals to the body that there is an excess of carbon dioxide in the blood, which has the effect of increasing breathing.

“By combining two agents with mechanisms known to reduce [apnea-hypopnea index] In a pharmaceutical formulation, we believe that the IHL-42X can benefit from a therapeutic advantage at lower doses of each safe and tolerable constituent drug, “said the company in its annual report.

Incannex by Melbourne, Australia, leads the phase 2 part of the IHL-42X clinical trial in the United States; Part 3 extended to phase 3 will include the United Kingdom and the European Union. The company provides for preliminary phase 2 data in the first half of this year.

Apnimed has his own carbon dioxide inhibitor for AOS. Last month, he acquired the global rights of sulthiame from the German company Desitin Arzneimtel, which had carried out phase 2 tests of the drug in OSA. Sulthiame is already available in certain countries in the form of a medication at epilepsy. Miller said that this small oral molecule gives APNIMED a candidate for AOS medication that works differently from AD109. The company will develop this drug for AOS and other sleep disorders thanks to a joint venture with Shionogi.

Apnimed’s latest financing took place in 2023 when he raised nearly $ 80 million, extending his C series to $ 142.2 million to finance the development of phase 3 of AD109. The company claims to have raised $ 270 million to date.

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