Aeolus Files Investigational New Drug Application With US Food and Drug Administration to Enable Initiation of Human Safety Studies for the Development of AEOL 10150 as a Medical Countermeasure Against Lung Damage From Radiation Exposure

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August 20th, 2014

Aeolus Pharmaceuticals, Inc. (OTCQB:AOLS) today announced that it has filed an Investigational New Drug Application (IND) with the Division of Medical Imaging Products of the US Food and Drug Administration (FDA) to enable the initiation of a phase 1 study of AEOL 10150 in healthy human volunteers. The new phase 1 study is designed as the first step in meeting the requirements for approval of the drug as a medical countermeasure for lung damage due to radiation exposure (Lung-ARS) under the FDA’s “Animal Rule.” Aeolus is developing AEOL 10150 for this indication under a five-year contract with the Biomedical Advanced Research and Development Authority (BARDA) valued at up to $118 million.

AEOL 10150 has previously been tested in 39 patients with Amyotrophic Lateral Sclerosis (ALS) in two phase 1 safety studies where it was well-tolerated with no Serious Adverse Events (SAE) reported. Through work performed under the BARDA contract, the manufacturing process and formulation of AEOL 10150 has been improved and the manufacturing cost has been reduced by approximately 90 percent. Bridging studies comparing the new, improved formulation of AEOL 10150 to the old formulation were recently completed. The old formulation met FDA regulatory/toxicity guidelines for clinical administration in multiple human studies. The new regulatory compliant (GLP) studies demonstrated that the toxicity and pharmacokinetics of the formulations were comparable. These studies also showed that the new formulation is less likely to cause irritation and has superior bioavailability in animals.

Stability studies with the new formulation have thus far demonstrated stability up to 24 months at room temperature and refrigerated conditions. Stability testing will continue to 60 months.

Efficacy studies in mice and non-human primates have shown that AEOL 10150 improves survival and reduces lung damage when given 24 hours after exposure to lethal levels of radiation. Lung ARS is a problem for which there is currently no approved treatment and the damage typically proves to be fatal in humans as well as in non-human primates and rodents.

“The filing of our IND for Lung-ARS is the culmination of a tremendous effort by our development team, and was made possible by BARDA’s investment in our technology and the valuable input and guidance we have received our BARDA Project Coordination Team and from the Medical Imaging Products Division and Office of Counter-Terrorism and Emergency Coordination at the FDA,” stated John L. McManus, President and Chief Executive Officer of Aeolus Pharmaceuticals, Inc. “I am grateful for the hard work and commitment of our employees and consultants and for the collaborative partnership we have with BARDA. As a result of our team’s efforts and BARDA’s investment and valuable input into our program, we are prepared to initiate a human safety study for Lung ARS Medical Countermeasure program once we have FDA clearance, and plan to quickly follow this study, with our first human studies in cancer.”

Assuming that the FDA accepts the IND and clinical protocol without restriction and that BARDA exercises the necessary program options, Aeolus plans to initiate a phase 1 study in healthy normal volunteers during the fourth quarter of 2014.

Aeolus currently has an IND in place with the FDA for ALS, and received orphan drug designation for lung damage resulting from Acute Radiation Syndrome (ARS) from the FDA’s Office of Orphan Product Development earlier this year. A filing for Fast Track Status is planned before the end of 2014. The Company also plans to file INDs for the development of AEOL 10150 in radiation therapy and for a respiratory disorder within the next 3 to 12 months.

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