Idiopathic Pulmonary Fibrosis Compound Gets Orphan Drug Status

Megan Brooks

March 18, 2015

The US Food and Drug Administration (FDA) has granted orphan drug status to an experimental compound for idiopathic pulmonary fibrosis known as AEOL 10150 (Aeolus Pharmaceuticals), the company said.

AEOL 10150 is a broad-spectrum catalytic antioxidant designed to neutralize reactive oxygen and nitrogen species, thereby reducing oxidative stress, inflammation, and subsequent tissue damage-signaling cascades resulting from radiation exposure, the company explains in a news release.

"We are very pleased that AEOL 10150 has been granted Orphan Drug Designation for the treatment of patients with idiopathic pulmonary fibrosis (IPF)," commented John McManus, Aeolus president and chief executive officer. "IPF is a terrible disease with limited treatment options. We look forward to providing further updates on our IPF program for AEOL 10150 in the near future."

AEOL 10150 may also have a "profound beneficial impact" on people who have been exposed, or are about to be exposed, to high-doses of radiation in cancer treatment, the company says. "AEOL 10150 has performed well in preclinical and non-clinical studies, demonstrating statistically significant survival efficacy in an acute radiation-induced lung injury model, and was well-tolerated in two human clinical trials," they note.

In line with those findings, Aeolus is also developing AEOL 10150 as a treatment for cancer patients receiving radiation therapy and for the pulmonary and delayed effects of acute radiation exposure under a contract with the Biomedical Advanced Research and Development Authority (BARDA), part of the US Department of Health and Human Services.

Aeolus is "grateful to BARDA for funding our program for AEOL 10150 for the treatment of the lung syndrome of acute radiation syndrome (Lung-ARS). The data generated in the BARDA program showing AEOL 10150's potent anti-fibrotic activity led directly to our filing for Orphan Drug status for IPF and our plans to develop 10150 in this indication," McManus said.

Orphan drug designation entitles the sponsor to a seven-year marketing exclusivity period, clinical protocol assistance with the FDA, and federal grants and tax credits. An orphan disease is a condition that affects fewer than 200,000 people in the US.

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