The U.S. Food and Drug Administration has agreed to Pulmatrix’s request to consider making the lung-fungus therapy Pulmazole (PUR1900) available to people with asthma in addition to people with allergic bronchopulmonary aspergillosis, or ABPA.
Regulators had already granted Pulmatrix a Qualified Infectious Disease Product (QIDP) designation for ABPA. They have now granted it a second QIDP designation for people with severe asthma. The agency must approve the therapy before doctors can use it to treat either patient group, of course.
ABPA is a disease marked by an exaggerated immune system response to the Aspergillus mold. It causes airway inflammation that can lead to bronchiectasis, or narrowing of the airways. It can also scar lung tissue.
Many asthma patients have allergic reactions to Aspergillus, a mold found in nature and inside buildings, according to the Centers for Disease Control and Prevention.
Doctors treat Aspergillus infections with corticosteroids and anti-fungal agents like itraconazole. Oral anti-fungals benefit some ABPA and asthma patients, but doctors limit their use because of safety concerns, including harmful interactions with other drugs.
The main problem is that patients need high doses of oral antifungals to get them through the bloodstream and into the lungs.
Pulmazole combines itraconazole with Pulmatrix’s proprietary dry powder iSPERSE technology. The powder formulation allows patients to inhale the drug directly to where it is needed – the lungs.
The combination also reduces the safety and tolerability concerns associated with non-inhaled therapies.
“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,” David L. Hava, chief scientific officer of Pulmatrix, said in a press release. “That should bring great benefits to patients.”
The QIDP program is aimed at accelerating the development of innovative drugs. The designation will give Pulmatrix five years of marketing exclusivity for Pulmazole once it’s approved.
Pulmatrix has also received a QIDP designation, as well as Orphan Drug Status, for Pulmazole as a treatment for fungal infections in the airways of cystic fibrosis patients.
“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 Robert Clarke, Pulmatrix’s chief executive officer.
“It will give us the benefit of an expedited regulatory review and significantly expands the potential population we can treat with our Pulmazole product,” he said. “This designation provides Pulmazole with five years of market exclusivity for treatment of fungal lung infections in these patients with ABPA.”