Orphan Drug Status was recently granted to an experimental compound, AEOL 10150, under development by Aeolus Pharmaceuticals to address the need for novel treatments for idiopathic pulmonary fibrosis.
AEOL 10150 is a broad-spectrum catalytic antioxidant thought to neutralize reactive nitrogen and oxygen species and, consequently, reduce inflammation, oxidative stress and subsequent tissue damage-signaling cascades that might result from radiation exposure, as the pharmaceutical company explains in a press release.
John McManus, Aeolus’ chief executive officer and president, said in a press release: “We are very pleased that AEOL 10150 has been granted Orphan Drug Designation for the treatment of patients with idiopathic pulmonary fibrosis (IPF). 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.”
In partnership with the Biomedical Advanced Research and Development Authority (BARDA), part of the US Department of Health and Human Services, Aeolus is also developing AEOL 10150 to serve as a therapy for cancer patients that are receiving radiation therapy, treating the pulmonary and delayed effects that result from acute radiation exposure.
According to McManus, 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.”
This orphan drug designation grants the company a 7-year marketing period of exclusivity, federal grants, clinical protocol assistance with the FDA and tax credits.
In other developments in pulmonary fibrosis, a phase III clinical trial sponsored by the Fundación Pública Andaluza para la gestión de la Investigación en Sevilla (FISEVI) in Spain is currently recruiting participants to enroll in a study designed to assess the efficacy of idiopathic pulmonary fibrosis (IPF) treatment, cotrimoxazole (TriSulfa-FPI). The study is entitled “Pilot Study Phase III to Evaluate the Efficacy and Safety of Trimethoprim-sulfamethoxazole in the Treatment of Idiopathic Pulmonary Fibrosis” and the clinical trial is registered under the identifier NCT01777737.