With a $10 billion market and a clinical shortage, the first 'Snoring medicine' is expected to hit the market

"There are 365 sunrises in a year, and I hear you snore 365 nights."

"I sleep for an hour, and I stop breathing 80 times. I am afraid that I will 'fall asleep' one day."

I know on the "roommate snoring, I can't stand it, what should I do" and "I was awakened by my roommate snoring in the dormitory, snoring is my fault" two questions, thousands of posts separated by empty words......

There is no cure for the cruelty of snoring.

But the latest research from Apnimed offers new hope for OSA patients.

Recently, Apnimed announced that MARIPOSA, the 2b clinical trial of AD109 for the treatment of OSA, met its primary endpoint, with both dose groups achieving a statistically significant reduction in AHI (p< 0.001). Among participants who completed the trial, 44% had greater than 50% reductions from baseline in apnea/hypopnea per hour of sleep with AD109, and 15% of AD109 recipients had 80% improvement.

AD109, developed by Apnimed, is an investigational new drug designed to be taken at bedtime, once a day, and could be a potential "First-in-Class" treatment for OSA. Phase 3 trials of AD109 will begin in the first half of next year.

Snoring is saved!

$10 billion market, OSA treatment drugs absent

Obstructive sleep apnea (OSA) is a disorder characterized by obstructive apnea and hypopnea caused by the repeated collapse of the upper airway during sleep. The symptoms include anxiety, snoring, recurrent awakenings, morning headache, and excessive daytime sleepiness.

According to a 2019 Lancet literature analysis based on 17 studies from 16 countries, OSA was judged by at least 5 events per hour of AHI (apnea-hypopnea index, which refers to the number of apnea-hypopnea plus hypopnea per hour of sleep, which is the main diagnostic and monitoring criterion for OSA). Or according to the 2012 American Academy of Sleep Medicine (AASM), the estimated number of people aged 30 to 69 with mild-to-severe OSA is 936 million worldwide.

OSA can cause intermittent hypoxia, hypercapnia and sleep structure disorder, and can lead to hypertension, coronary heart disease, arrhythmia, cerebrovascular disease, cognitive impairment, type 2 diabetes and other multi-organ and multi-system damage.

The study found that the mortality rate of untreated patients with severe 0SA was 3.8 times higher than that of the general population.

However, there is currently no registered medical treatment regimen for OSA, and the standard treatment option is a mechanical continuous positive airway pressure (CPAP) device. However, adherence to CPAP devices is low and the related treatment costs are high. It is reported that the global market for the use of CPAP devices to detect and treat OSA exceeds 10 billion US dollars each year.

The latest! Research and development progress of 4 OSA drugs

At present, the OSA drugs under development worldwide include IHL-42X (Incannex), AD109 (Apnimed), Tirzepatide (Eli Lilly), BAY 2586116 nasal spray (Bayer), etc. In general, AD109 has made rapid progress and is expected to become the first drug to improve OSA snoring symptoms.

IHL-42X (Incannex Corporation)

IHL-42X, a key candidate in Incannex's six cannabinoid development programs, is a fixed-dose combination of dronabinol (commonly referred to as tetrahydrocannabinol THC) and acetazolamide, designed as a tablet for the treatment of OSA in adults.

The newly published phase 2 proof-of-concept clinical trial data show that IHL-42X is effective in the treatment of OSA. "The mean AHI during all IHL-42X treatment periods (using low, medium, and high doses) was 44.4% lower than baseline AHI, whereas the mean AHI during placebo was only 6.4% lower than baseline."

AD109 (Apnimed Corporation)

AD109 is a combination of atomoxetine, a selective norepinephrine reuptake inhibitor, and aroxybutynin, an antimuscarinic agent, administered once daily at bedtime.

AD109 targets the key neural pathways of OSA, activates the upper airway dilator muscles, so that patients can still maintain the airway smooth during sleep, and was granted fast track status by the FDA in June this year.

Recently, MARIPOSA, the 2b clinical trial of AD109 for OSA, met its primary endpoint: patients in both dose groups achieved a statistically significant reduction in AHI (p< 0.001). Moreover, among participants who completed the trial, 44% had a greater than 50% reduction from baseline in apnea/hypopnea episodes per hour of sleep with AD109, and 15% of AD109 recipients had an 80% improvement.

Phase 3 trials of AD109 will begin in the first half of next year.

Tirzepatide (Eli Lilly)

Tirzepatide, a novel GLP-1R/GIPR dual agonist that requires a once-weekly subcutaneous injection, was approved by the FDA in May for treating type 2 diabetes.

Forthcoming results from SURMOUNT-1, a global phase 3 trial of the drug in people with obesity or overweight: Patients who received Tirzepatide (5mg, 10mg, and 15mg) all lost significantly more weight than those who received placebo at week 72, with a mean weight loss of 22.5% (approximately 24 kg) in the subgroup receiving the highest Tirzepatide dose (15mg). 63% of these subjects lost at least 20% of their body weight.

In April this year, the drug was approved for clinical use in China as a single intervention drug for adult patients with moderate to severe OSA and BMI≥30 kg/m2.

BAY 2586116 (Bayer)

BAY 2586116 is a potassium-channel blocker that activates the genioglossus muscle to maintain upper airway stability.

Two drugs for excessive daytime sleepiness (EDS) were approved

It is worth mentioning that in recent years, two drugs have been approved for the treatment of OSA-related excessive daytime sleepiness (EDS), namely Jazz Pharmaceutical's Sunosi (solriamfetol) and Bioprojet's Ozawade (pitolisant).

Sunosi Active ingredient is a selective dopamine and norepinephrine reuptake inhibitor (DNRI) that was approved by the FDA in March 2019 for the treatment of excessive daytime sleepiness (EDS) associated with narcolepsy or OSA in adult patients.

Ozawade active ingredient is a selective histamine 3 (H3) receptor antagonist/inverse agonist, which increases the synthesis and release of the wakefulness promoting neurotransmitter histamine in the brain by enhancing the activity of histaminergic neurons, and improves the wakefulness and alertness of patients. In October 2021, the drug was approved in Europe for the treatment of EDS associated with OSA in adult patients.

There may be a cure for snoring.