AEOL 11114

AEOL 11114 was developed by Brian J. Day, PhD at National Jewish Health and Manisha Patel, PhD at the University of Colorado, Anschutz Medical Campus, Department of Pharmaceutical Sciences in collaboration with Aeolus and under two research grants from the Michael J. Fox Foundation for Parkinson’s disease. Aeolus has obtained worldwide, exclusive licenses to develop the compounds from National Jewish Health and the University of Colorado.

Preclinical studies funded by the Michael J. Fox Foundation in two models of Parkinson’s disease demonstrated that AEOL 11114 reduced oxidative stress and damage, mitigated dopamine depletion, prevented loss of nigrostriatal dopaminergic neurons, the most important neuropathological feature of Parkinson’s disease, and improved Parkinson’s disease-like motor deficits. Additional studies funded by the Fox Foundation have shown that AEOL 11114 exhibited drug-like characteristics with a favorable pharmacokinetic profile, oral bioavailability, metabolic stability and brain penetrance, and a safety profile amenable for long-term dosing.

Aeolus is currently working on optimization of the AEOL 11114 manufacturing process and formulation. Upon completion of this work, IND-enabling safety and toxicology studies are planned to begin in the third quarter of 2016. Aeolus plans to file an IND for the treatment of patients with Parkinson’s disease during the first half of 2017. The Company intends to pursue a partner with clinical development expertise in this indication to initiate clinical studies.

Parkinson's disease is a disorder of the central nervous system that results from the loss of cells in various parts of the brain, including the substantia nigra. The substantia nigra cells produce dopamine, which transmits signals within the brain that allow for coordination of movement. Loss of dopamine causes neurons to fire without normal control, reducing a patient’s control of their movement. It is estimated that more than one million people in the United States and five million people worldwide are affected by Parkinson’s disease.