Apnimed treatment shows reduction in AHI

CAMBRIDGE, Mass. – Apnimed, a pharmaceutical company focused on developing oral pharmacologic treatments to address obstructive sleep apnea and related disorders, has announced positive topline results from a proof-of-concept randomized, controlled, double-blind, single-dose, three-period crossover study (protocol APX-001) in patients with OSA evaluating AD504 and AD182. Patients treated with AD504 (atomoxetine plus trazodone) showed a strong trend in the reduction in AHI from placebo, which was the study’s primary endpoint. Additionally, the study’s secondary endpoint was met with a significant reduction of sleep apnea specific hypoxic burden (HB) following treatment with AD504. HB is a measure of the total amount of respiratory event-related hypoxemia and a growing body of evidence supports HB as the most meaningful predictor of adverse cardiovascular outcomes in patients with OSA. A second drug, AD182 (atomoxetine and an orexin antagonist) was also studied and demonstrated a positive trend in the reduction of HB. “We’re pleased with the reduction in HB demonstrated by AD504 in this small, proof-of-concept, Phase 2 study,” said Larry Miller, M.D., CEO of Apnimed. “In our pursuit to deliver breakthrough oral medications to patients with OSA, we are exploring multiple drug combinations and patient subpopulations. This drug combination involving a medication commonly prescribed for sleep problems could particularly benefit OSA patients with disturbed sleep – difficulty initiating and maintaining sleep – which we believe represents an important sub-population of OSA patients.”