AEOL 10150 is an experimental, catalytic anti-oxidant-based therapy being developed by Aeolus Pharmaceuticals for a range of diseases and conditions, including idiopathic pulmonary fibrosis (IPF). Aeolus, in partnership with the U.S. Department of Health and Human Services, is focused on developing novel compounds like AEOL 10150 that are targeted at addressing national security threats like treating the effects of chemical radiological weapons and nuclear gases. The California-based company also develops therapies for diseases like amyotrophic lateral sclerosis (ALS), stroke, spinal cord injury, lung inflammation, and mucositis.
History of AEOL 10150
Aimed at a broad spectrum of diseases, AEOL 10150 was originally tested as a treatment for amyotropic lateral sclerosis (ALS) in clinical trials, for which Aeolus filed and received Fast Track status from the FDA in October 2005. Subsequently, the therapy underwent additional clinical trials in 2006 to verify the drug’s safety, efficacy, and tolerability. Positive results followed, leading Aeolus to file an Investigational New Drug (IND) application with the FDA.
Now, AEOL 10150’s development has expanded and is being tested as a treatment for the effects of radiation and nuclear and sulphur gases in the lungs, as well as fibrotic diseases. This new round of testing and development is being conducted in partnership with the Biomedical Advanced Research and Development Authority (BARDA), a division of the U.S. Department of Health and Human Services, under a $118 million, five-year contract awarded in February 2011. It fully funds all developmental activities required for FDA approval.
The BARDA contract also funds the development of large-scale manufacturing sufficient to meet potentially large orders from the government. If the development program is successful, AEOL 10150 would be a candidate for procurement for the U.S. Strategic National Stockpile.
How AEOL 10150 Works
Idiopathic pulmonary fibrosis (IPF) is an important disease that Aeolus believes AEOL 10150 can effectively treat. The company, along with BARDA, has conducted preclinical studies on mice with fibrotic lungs, testing the drug’s effectiveness in improving their condition. Having observed success in early trials, the company filed for Orphan Drug Designation for AEOL 10150 for treating IPF and similar diseases. The status was granted in March 2015.
The main mode of action of AEOL 10150 is neutralization of reactive oxygen and nitrogen spices, which helps in reducing oxidative stress and reduces inflammation as well as tissue damage occurring from signal transduction pathways from exposure to radiation.
Next Steps for AEOL 10150
The company plans to apply for an IND for AEOL 10150 for the treatment of IPF this year, and begin clinical trials as soon as possible. If approved by the FDA, AEOL 10150 would offer another viable therapeutic option for treating the underlying cause of IPF, in addition to the already approved Esbriet (Roche) and Ofev (Boehringer-Ingelheim).
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