Advertisement Barda exercises $3m in additional contract funding to develop Aeolus' AEOL 10150 to treat acute radiation syndrome - Pharmaceutical Business review
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Barda exercises $3m in additional contract funding to develop Aeolus’ AEOL 10150 to treat acute radiation syndrome

Aeolus Pharmaceuticals, a biotechnology company developing compounds to protect against radiological and chemical threats in partnership with the US Government, announced that the Biomedical Advanced Research and Development Authority (BARDA) exercised $3m in additional contract options under its advanced research and development contract for AEOL 10150.

BARDA is a division of the U.S. Department of Health and Human Services that manages the advanced development and purchase of medical countermeasures for public health threats.

Aeolus is developing its lead compound, AEOL 10150, as a treatment for the pulmonary syndrome of Acute Radiation Syndrome (Lung-ARS) and delayed effects of acute radiation exposure (DEARE) under a contract with BARDA worth up to $118m.

The contract is designed to produce the data necessary for an approval under the FDA "Animal Rule" and for a pre-Emergency Use Authorization (EUA) filing. An approval or pre-EUA would allow the federal government to buy AEOL 10150 for the Strategic National Stockpile under the Pandemic All-Hazards Preparedness Reauthorization Act (PAHPRA).

PAHPRA is designed to accelerate the research, development, purchase and availability of effective medical countermeasures for the Strategic National Stockpile.

The options include funding for the following development items:
– Laboratory work suggested by the FDA as a pathway to removing the clinical hold on the IND for AEOL 10150 in Lung-ARS
– Ongoing animal studies to optimize the administration of AEOL 10150 for Lung-ARS, including duration of treatment and delayed treatment studies
– Project management costs

On March 12, 2015, Aeolus met with the Division of Medical Imaging Products at the FDA to discuss the Company’s action plan for a complete response to the clinical hold on the IND for AEOL 10150 in Lung-ARS. The discussion at the meeting focused on the path forward to a Phase 1 study in healthy normal volunteers.

The FDA asked the Company to perform laboratory studies designed to confirm the non-mutagenic mechanism of action (MOA) by which AEOL 10150 has created "false" positives in "in-vitro" (test-tube) studies for mutagenicity. "In-vivo" (animal studies) have been negative — indicating that AEOL 10150 is not mutagenic. If these studies confirm the MOA, the clinical hold may be lifted.

The FDA indicated that if the studies do not confirm the MOA, the hold may be lifted upon completion of a transgenic mouse carcinogenicity study, which will be initiated immediately and run concurrent to the MOA studies.

In addition, the Company asked the FDA for guidance on which cancer indication would be more appropriate for creating data to support the Lung-ARS indication in an approval under the Animal Rule. The FDA recommended studies in lung cancer patients.

"We appreciate the FDA’s helpful guidance on a clear, expeditious path forward to a Phase 1 study in healthy normal volunteers for AEOL 10150," commented John McManus, President and CEO of Aeolus.

"The specific recommendations for laboratory work provide us with a well-defined route to lifting the clinical hold. We believe that this work can be completed in a very short period of time and we look forward to presenting our results to the FDA."