Today, Pulmatrix, Inc. announced that Pulmazole (PUR1900), its drug candidate for treating pulmonary fungal infections, has been designated as a “Qualified Infectious Disease Product” (QIDP) in a second indication by the U.S. Food and Drug Administration (FDA).
With the new designation, the drug, which is intended to treat fungal infections in the airways of patients with cystic fibrosis (CF), can now exclusively be marketed by Pulmazole (PUR1900) for the next 5 years. The QIDP program is designed specifically to expedite the development of new drugs against chief pathogens, and the status increases the eligible allergic bronchopulmonary (ABPA) population to include asthmatic patients.
Per a press release
, in its letter to Pulmatrix, the FDA wrote: In its letter to Pulmatrix, the FDA wrote: "We have reviewed your request and conclude that it meets the criteria for QIDP. Therefore we are designating your Itraconazole Inhalation Powder (PUR1900) product for inhalation use as a QIDP for treatment of pulmonary Aspergillus infections in patients with allergic bronchopulmonary aspergillosis (ABPA)."
By combining itraconzole with its innovative dry powder iSPERSE (inhaled small particles easily respirable and emited) technology, Pulmatrix is setting out for Pulmazole (PUR1900) to eliminate the need for symptom management via corticosteroids and antifungal agents. While oral antifungals have been proven to provide respiratory benefit, they are often limited by tolerability, safety and drug-drug interaction concerns based on the dosage.
Very high oral doses are typically required for the lungs to get enough of the drug through the bloodstream and actively challenging the fungus.
The combination drug will make it feasible for patients to inhale the drug directly into their lungs and have it travel straight to the site of infection. There, it will reduce the amount of drug that penetrates the systemic circulation, making it both safer and better tolerated.
"This second QIDP designation is a significant boost to our efforts to make this drug available as quickly as possible to severe asthma patients suffering from fungal lung infections," said Pulmatrix CEO Robert Clarke, PhD. "It will give us the benefit of an expedited regulatory review and significantly expands the potential population we can treat with our Pulmazole product. This designation provides Pulmazole with 5 years of market exclusivity for treatment of fungal lung infections in these patients with ABPA."
At present, approximately 75,000-100,000 patients are affected by CF, and an estimated 1.5% of adult asthmatics suffer from ABPA.
"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 and reduced drug-drug interaction concerns," explained Pulmatrix's Chief Scientific Officer, David L. Hava, PhD. "That should bring great benefits to patients."
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