Following the success of its second Phase III trial on its investigative sleep apnoea medication, Apnimed has doubled down on its pledge to submit a New Drug Application (NDA) for the lead asset to the US Food and Drug Administration (FDA).
This decision was prompted by topline results of the LunAIRo trial (NCT05811247), which demonstrated AD109’s capacity to reduce participants’ symptom severity by 46.8% as recorded by average apnoea-hypopnea index (AHI) from baseline within 26 weeks. This is compared to a 6.8% drop in placebo.
The drug also met a range of secondary endpoints, offering clinically meaningful improvements in overall oxygenation, while 51.2% of patients dropped a severity category following treatment with AD109.
These findings follow the equally positive results of the Phase III SynAIRgy trial (NCT05813275), which found that the drug can lessen AHI by 55.6% on average.
To keep the wheels in motion, the Massachusetts-based biotech plans to draft and submit an NDA for US approval by early 2026 — which will likely be expedited due to the FDA’s decision to grant Fast Track Designation to the therapy in 2022.
If the regulator decides to give AD109 the green light, it will be the first of its kind in this indication, targeting the root cause of sleep apnoea symptoms by improving muscular strength in the upper airway.
Its approval could also address the unmet needs of sleep apnoea patients who are unable to rely on traditional methods such as continuous positive airway pressure (CPAP) therapy.
A solution for all weight categories
Obstructive sleep apnoea is a highly prevalent condition worldwide, with an estimated 936 million people suffering from this chronic disease.
It is also a highly lucrative market, with medical devices catered to apnoea treatment banking $3.7bn in 2020 alone, according to GlobalData — the parent company of Clinical Trials Arena.
However, available treatment options have stagnated in recent years, with patients generally being advised to lose weight or rely on CPAP therapy.
The only pharmaceutical intervention available for sleep apnoea is Eli Lilly’s glucagon-like peptide-1 receptor agonist (GLP-1RA) Zepbound (tirzepatide); however, this is only for use in sleep apnoea patients with obesity.
According to a 2024 review published in Sleep Medicine, only 37% of those with obstructive sleep apnoea are considered clinically obese, suggesting that weight loss-focused lifestyle changes are likely unapplicable for most of this patient population.
This highlights the strong need for alternative solutions that are both effective, convenient and patient-centric.
“A majority of the 80 million US adults with obstructive sleep apnoea remain untreated, highlighting the significant unmet need amongst this patient population,” noted Apnimed’s CEO, Larry Miller.
“We believe AD109 — a once-daily oral drug designed for patients in all weight categories — has the potential to expand and reshape the sleep apnoea treatment landscape, while representing a notable commercial opportunity for Apnimed,” Miller concluded.
