Business
Pulmatrix Receives Fast Track Designation for Pulmazole for the Treatment of Asthma-ABPA
LEXINGTON, Mass., Jan. 30, 2020 /PRNewswire/ -- Pulmatrix, Inc. (NASDAQ: PULM) today announced that the U.S. Food and Drug Administration (FDA) has granted
About this update from Pulmatrix, Inc.
[{"type":"text","content":"LEXINGTON, Mass., Jan. 30, 2020 /PRNewswire/ -- 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.\n\n \n \n\n \n\"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.\" \nA 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. \nWilliam 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 th...