Itraconazole inhalation powder (Pulmazole [also known as PUR1900], Pulmatrix), a drug candidate for treating fungal infections in the lungs, has been designated as a qualified infectious disease product (QIDP) in a second indication by the FDA.
Under the QIDP program, which is designed to speed the development of novel drugs against important pathogens, Pulmatrix will receive five years of additional market exclusivity for Pulmazole. The drug previously received QIDP status as well as an orphan drug designation from the FDA to treat fungal infections in the airways of patients with cystic fibrosis, a rare genetic disease estimated to affect 75,000 to 100,000 patients worldwide. This new QIDP status expands the eligible allergic bronchopulmonary aspergillosis (ABPA) population to include asthmatic patients; 1.5% of adult asthmatics suffer from ABPA.
Currently, many asthma patients experience allergic reactions when their lungs become infected with the fungus aspergillus. Doctors now try to treat those infections with oral drugs, such as corticosteroids, and antifungal agents, such as itraconazole. Oral antifungals have been shown to provide benefit in treating ABPA in asthma patients but are limited by tolerability, safety, and drug–drug interaction concerns based on the dosing profile. Typically these agents require very high oral doses to get enough of the drug to the lungs through the bloodstream to fight the fungus, leading to the safety and tolerability concerns, according to a company press release.
The company stated that its goal is to solve this problem by combining itraconazole with its dry powder technology called iSPERSE. The combination of iSPERSE and itraconazole makes it possible for patients to inhale the drug into their lungs to the site of infection, where it's needed, while reducing the amount of drug that gets into the systemic circulation, which drive the safety and tolerability concerns.
Source: Pulmatrix, Inc.; October 3, 2017.