A European patent has been issued covering the composition of matter for Aeolus Pharmaceuticals’ AEOL 11114, an oral Parkinson’s disease (PD) drug. A patent for AEOL 11114 has also been allowed in Japan.
AEOL 11114 was created by Brian J. Day, Ph.D., of National Jewish Health, and Manisha Patel, Ph.D., of the University of Colorado, in collaboration with Aeolus Pharmaceuticals and under two research grants from the Michael J. Fox Foundation for Parkinson’s disease. The drug has demonstrated neuro-protective activity in models of Parkinson’s disease and other indications.
Aeolus, which holds exclusive rights to AEOL 11114, is currently optimizing its formulation and manufacturing process, which will be followed by studies to assess the drug’s toxicity and safety. These studies should begin later this year. Aeolus expects to file an FDA Investigational New Drug Application (IND) of AEOL 11114 for patients with Parkinson’s disease in first half of 2017.
AEOL 11114 has been tested for pharmacokinetics, maximum tolerated dose, dosing paradigm, drug stability, and drug protein binding and efficacy in preclinical studies using two animal models of Parkinson’s. The data revealed that the compound protects against oxidative stress, improves functioning on behavioral assessments, and eases dopamine depletion in the 6-hyroxydopamine model of Parkinson’s.
These data indicate that AEOL 11114 can be given following a 6-hydoxydopamine lesion in mice to attain neuroprotection. Furthermore, administration of AEOL 11114 was found to reduce oxidative stress and to protecte against behavioral impairments as well as loss of striatal dopaminergic neurons in the Substantia Nigra Pars Compacta (SNPc).
“AEOL 11114 has exciting potential as a Parkinson’s disease treatment given its mechanism of action, its pharmacokinetic and safety profile, and the significant efficacy it has demonstrated in two widely used animal models of the disease,” said John L. McManus, president and CEO of Aeolus Pharmaceuticals, in a press release. “We now have active development programs for three compounds in seven indications. Our Parkinson’s program in AEOL 1114 joins our development programs for AEOL 10150 in Pulmonary Acute Radiation Syndrome, Radiation Therapy for Cancer, and Idiopathic Pulmonary Fibrosis.
“In addition, we are currently conducting pre-clinical studies in our infectious disease compound, AEOL 20415, with the intention of filing an IND in 2017. With our substantial U.S. government development contract for AEOL 10150 in Acute Radiation Syndrome, the planned human clinical trials in IPF and radiation oncology and the new compounds in development, the company has never been more diversified or better capitalized,” McManus said.