Breakthrough Clinical Results

Apnimed announced additional data from its Phase 3 SynAIRgy and LunAIRo trials evaluating AD109 (aroxybutynin 2.5 mg/atomoxetine 75 mg) for obstructive sleep apnea (OSA). The studies met their primary endpoint, showing a significant reduction in apnea-hypopnea index (AHI) at 26 weeks. AD109 also demonstrated clinically meaningful improvements in oxygenation, including significant reductions in the oxygen desaturation index (ODI3) and hypoxic burden (HB4) compared with placebo. Apnimed is preparing for a planned New Drug Application (NDA) submission to the U.S. Food and Drug Administration.

Incidence and Prevalence

Latest Estimates of Obstructive Sleep Apnea Prevalence and Incidence

Global Prevalence

According to the most recent information from 2024, sleep disorders affect approximately 30% of the adult population and 5-10% of children worldwide. More specifically, Obstructive Sleep Apnea (OSA) affects about 3-7% of the global population based on a 2022 publication, though it is often undiagnosed.

Earlier estimates from 2007 suggested that OSA was prevalent in 2% to 4% of working middle-aged adults. However, more recent studies indicate that OSA has a considerable epidemiological impact, with demand for consultation growing in communities.

Demographic Variations

A 2025 study examining racial, ethnic, and sex differences revealed significant variations in OSA metrics among different populations:

• Among 821 participants (mean age=66.6±8.5 years), 50.5% had moderate-to-severe OSA
• Black females had the highest REM-REI (respiratory event index during REM sleep)
• Non-Hispanic White males had the lowest REM-REI
• After controlling for various factors, Black participants had a REM-REI 3 events/hour higher than non-Hispanic White adults

A 2008 Singapore study of 584 diagnostic polysomnography (PSG) studies found that OSA is predominant in middle-aged, overweight males and much less common in females, who tend to be older when diagnosed.

Regional Variations

A 2025 Nigerian study of undergraduates found: - 14.41% reported abnormal sleepiness using the Epworth Sleepiness Scale - 4.3% had a moderate to high risk of OSA using the Stop Bang Questionnaire

A 2023 systematic review in Latin America found socioeconomic status impacts sleep health, with studies predominantly from Brazil (80%), Peru (10%), Chile (5%), and multicentric studies (5%).

Severity Classification

In the Singapore study, OSA severity was classified as: - AHI <5 ("Normal Overall AHI"): 28.3% - AHI 5-15 ("Mild"): 22.3% - AHI >15-30 ("Moderate"): 18.3% - AHI >30 ("Severe"): 31.2%

Comorbidities

OSA prevalence is significantly higher in certain patient populations: - In patients with primary Sjögren's syndrome, OSA was detected in 84% of patients - A 2014 study found higher prevalence of respiratory conditions among OSA patients compared to controls:

• COPD: 7.6% vs 3.7%

• Asthma: 10.4% vs 5.1%

• COPD plus asthma: 3.3% vs 0.9%

Overall, OSA represents a significant global health concern with varying prevalence rates across different populations and demographic groups, and is described as a challenging medical problem due to its prevalence and impact on quality of life.

Company drugs in pipeline

Apnimed's Drug Pipeline Indications

I don't have specific information about Apnimed's drug pipeline indications in the provided context. The context sections are marked as "NA" for both title and answer, which means there is no available data about Apnimed's drug development programs, targeted medical conditions, or clinical trial phases.

To properly answer this question would require information about:

• The specific medical conditions Apnimed is targeting
• The development status of their drug candidates
• The clinical trial phases of their pipeline products
• Any therapeutic areas they specialize in

Without this information in the context, I cannot provide details about which indications Apnimed has drugs in pipeline for.