The US Food and Drug Administration has granted Orphan Drug Designation for investigational drug candidate, iclaprim to treat Staphylococcus aureus lung infections in patients with cystic fibrosis, according to manufacturer Motif Bio.
Iclaprim has been studied in an animal model of chronic pulmonary methicillin resistant Staphylococcus aureus (“MRSA”) infection, which mimics the pathophysiology observed in the lungs of patients with cystic fibrosis. Data will be presented at IDWeek on October 6, 2017 in San Diego, according to Motif Bio.
“Staphylococcus aureus, including MRSA, is one of the common causes of lung infections in patients with cystic fibrosis and we do not believe that any antibiotic has been approved for this indication. Some 80% or more of patients with cystic fibrosis die as a result of respiratory infections caused by a variety of bacteria, and MRSA infections have been growing in recent years,” said Graham Lumsden, CEO of Motif Bio. “Formulation development work is underway at Motif Bio to explore potential intravenous and inhaled formulations designed specifically for cystic fibrosis patients.”
Orphan designation grants special status to a drug or biologic under development to treat a rare disease or condition and qualifies the sponsor of the product for various development incentives, including tax credits for qualified clinical testing, waiver of user fees and potentially up to seven years of market exclusivity for the given indication, if approved.