December, 2025 Aeon Respire has successfully completed a dose range finding non-GLP toxicology study of AR-001 in two species. The study was performed by Lovelace Biomedical (Albuquerque, NM) and included both single and repeat-dose exposures. Aerosolized AR-001 was delivered by inhalation to Sprague Dawley rats to determine a dose range and maximum tolerated dose (MTD) or maximum feasible dose (MFD). Aerosolized AR-001 was also delivered via face mask inhalation exposure to male and female beagle dogs.

Inhaled AR-001 provided high levels of lung exposure that were predicted to cover the target and a suitable safety margin that supports further development.  These data provide valuable information about AR-001’s tolerability and help inform margin calculations and projected doses for formal GLP toxicology studies and first-in-human studies. The company looks forward to executing these IND-enabling studies and moving AR-001 into proof-of-concept human studies.