Positive results for Apnimed’s AD109 for treating obstructive sleep apnoea

Apnimed has announced positive topline results from its second pivotal Phase 3 clinical trial – LunAIRo - of Apnimed's lead candidate AD109 (aroxybutynin 2.5mg/atomoxetine 75mg), for treating obstructive sleep apnoea OSA). LunAIRo was a 12-month study that evaluated the efficacy and safety of AD109 in adults with mild, moderate and severe OSA, across a wide range of weight classes, with the primary endpoint determined at 26 weeks.

The LunAIRo trial met its primary endpoint, demonstrating clinically meaningful and statistically significant reductions in airway obstruction at 26 weeks. Participants treated with AD109 achieved a mean reduction in AHI of 46.8% from baseline at week 26 (vs 6.8% with placebo; p<0.001). The reduction in AHI remained significant at end of study (week 51, p<0.001). AD109 was generally well-tolerated, with the most common treatment-emergent adverse events being mild or moderate in severity, and consistent with prior studies. No serious adverse events related to AD109 were reported in the LunAIRo trial.

In addition to meeting the primary endpoint, AD109 demonstrated improvements in additional topline secondary and exploratory endpoints in the LunAIRo study, including:

• Meaningful improvements in oxygenation as assessed by reductions in hypoxic burden (p<0.0001) and oxygen desaturation index (p<0.001) at week 26 and at end of study (week 51)

• A significant proportion of participants achieved a ≥50% reduction in AHI from baseline at week 26 (p<0.0001) and at week 51 (p<0.0001)

• AD109 improved OSA disease severity for 45.0% of participants at week 26, and 47.5% at week 51

• AD109 achieved OSA complete disease control (AHI<5) for 22.9% of participants at week 26, and 22.5% at week 51

"The consistency of the promising findings across both the LunAIRo and SynAIRgy trials provides robust clinical evidence that AD109 meaningfully improved sleep apnea severity and oxygenation," said Dr Sanjay Patel, study chair for the LunAIRo clinical trial and Director, UPMC Comprehensive Sleep Disorders Clinical Program in Pittsburgh, Pennsylvania. "This is the first time we've seen a once-daily oral medication demonstrate such significant, durable effects in a broad patient population with OSA."