The U.S. Food and Drug Administration (FDA) has designated PUR1900 a Qualified Infectious Disease Product (QIDP) as a potential treatment of fungal infections in the lungs of patients with cystic fibrosis(CF), its developer, Pulmatrix, announced.
This designation accelerates the development of new treatments against infectious agents, and protects the exclusivity of PUR1900 for five years if it reaches the market.
“The new QIDP designation is a significant boost to our efforts to make this drug available as quickly as possible to cystic fibrosis (CF) patients suffering from fungal lung infections,” said Robert Clarke, PhD, CEO of Pulmatrix, in a press release. “It will give us the benefit of an expedited regulatory review. Added to our existing FDA Orphan drug designation for PUR1900, it will give us a full 12 years of market exclusivity.”
CF is caused by mutations in the CFTR gene, which contains the coding information for a protein with the same name. When dysfunctional, this protein contributes to the accumulation of mucus in several organs, which can promote the growth of infection-causing pathogens. In the lungs, excessive bacterial or fungal growth leads to lung disease.
Infection by the fungus Aspergillus can lead to allergic reactions. Treatments include itraconazole, an oral antifungal agent, but this drug needs to be given in high doses so that the lungs receive enough of it through the bloodstream. Excessive use of itraconazole, however, can put people at risk of severe side effects, including liver damage.
PUR1900 is an inhaled antifungal treatment combining itraconazole with the company’s dry powder iSPERSE technology, allowing patients to inhale the drug, at high dose, directly into their lungs. In this way, PUR1900 is designed to both target the drug to the Aspergillus infection, and reduce the toxicity associated with higher doses of itraconazole to other organs.
“By delivering the drug directly to the lungs, we should be able to fight the infection far more effectively than the oral drug can, with far fewer side effects,” said David Hava, PhD, and chief scientific officer of Pulmatrix. “That should bring great benefits to patients.”