Pulmatrix, Inc. (NASDAQ: PULM) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to PUR1900 ("Pulmazole"), the Company's inhaled itraconazole antifungal candidate being developed to treat allergic bronchopulmonary aspergillosis (ABPA) in patients with asthma.
Pulmatrix is currently enrolling patients in its ongoing randomized, double-blind, placebo-controlled Phase 2 study evaluating the safety, tolerability, pulmonary function and biomarker response of Pulmazole in subjects with asthma-ABPA. Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier.
“Patients with asthma-ABPA have an urgent need for new therapeutic options that reduce the severe side effects associated with current standard of care treatments,” said Ted Raad, chief executive officer of Pulmatrix. “We view this FDA Fast Track designation as continued support that Pulmazole, enabled by Pulmatrix’s iSPERSE delivery technology, has the potential to advance towards a first line treatment option for ABPA patients. With our Phase 1/1b trial successfully meeting all endpoints, we are now focused on advancing our ongoing Phase 2 study, leveraging the important advantages of Fast Track designation, and look forward to reporting study results by year end.”
A drug that receives Fast Track designation may be eligible for more frequent interaction and communication with the FDA on matters pertaining to the drug’s development plan as well as eligibility for accelerated approval and priority review. However, Fast Track designation does not guarantee that a drug candidate will receive FDA approval in a timely manner, or at all.
William J Calhoun, M.D., Professor of Internal Medicine, Pulmonary, Allergy and Clinical Immunology, and Vice Chair for Research, Department of Internal Medicine, University of Texas Medical Branch and co-lead investigator of the Phase 2 study said, “Approximately half of ABPA patients do not respond to first line treatment with oral steroids which carry risks of dependence and complications from long-term use. While effective, second-line oral antifungals are limited in their use due to safety and tolerability concerns. Pulmazole, which is being tested as an inhaled antifungal, has shown promising Phase 1/1b study results enabling approximately 50-fold higher lung delivery at 1/10th the dosing of oral itraconazole. I believe Pulmazole has the potential to shift the standard care for ABPA by addressing the underlying cause of inflammatory responses while avoiding the significant limitations in efficacy and safety associated with oral steroid and antifungal standard of care treatment.”
The Phase 2 study is a global, multicenter, 4 arm trial. Enrolled subjects will be randomly assigned (1:1:1:1) into 4 arms of 16 subjects each (n=64 total) and will receive 10 mg, 20 mg, or 35 mg of Pulmazole or placebo, administered via dry powder inhalation once daily for 28 days. The primary objective of the study is to evaluate the safety and tolerability of multiple-dose administration of Pulmazole given to adult subjects with asthma and ABPA. Secondary objectives include characterizing the pharmacokinetics of multiple dose administration of inhaled Pulmazole in plasma and sputum, as well as evaluating the effect of Pulmazole on relevant biomarkers of inflammation, pulmonary function (FEV1), asthma symptoms, and aspergillus burden in sputum.
Source: Company Press Release