Pulmatrix (NSDQ:PULM) shares were up 159% to $1.79 apiece in mid-afternoon trading today after the company announced that its drug candidate for treating fungal infections in the lungs of cystic fibrosis patients was designated as a ‘qualified infectious disease product’ by the FDA.
With the designation, the Lexington, Mass.-based company will receive 5 years of market exclusivity for the drug candidate.
“The new QIDP designation is a significant boost to our efforts to make this drug available as quickly as possible to cystic fibrosis patients suffering from fungal lung infections,” Pulmatrix CEO Robert Clarke said in prepared remarks. “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.”
Cystic fibrosis patients often experience allergic reactions when their lungs are infected with aspergillus fungus, according to Pulmatrix. Traditionally, doctors try to treat those infections with high doses of oral antifungals, but they can cause severe side effects and are not always effective.
Pulmatrix uses its dry powder iSperse technology in combination with itraconazole, a common oral antifungal, which enables the patient to inhale the drug directly into their lungs.
“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,” chief scientific officer David Hava added. “That should bring great benefits to patients.”
