Pulmatrix Inc. (NASDAQ:PULM) stock surged 7% following the announcement that the FDA had accepted Pulmazole as an IND. However in the previous trading session the stock dropped 10.14% to close the day at $1.33.
The latest drop comes at the back of the FDA indicating that they had completed review of the company’s Investigative new Drug application. The FDA authorized Pulmatrix to begin the second phase clinical Pulmazole (PUR1900) investigation
Pulmazole is an anti-fungal itraconzole iSPERSE formulation that can be inhaled to treat Asthma patients with allergic bronchopulmonary aspergillosis.
Initiating safety and tolerability study of itraconazole
Following the approval of the application for Investigational New Drug, Pulmatrix is planning to initiate the second phase study of PUR1900 in the first half of 2019. The study will evaluates the tolerability safety as well as the pharmacokinetics of pulmazole that shall get administered as an inhaling powder PUR1900 for allergic Bronchopulmonary aspergillosis patients with Asthma.
In the double-blind randomized placebo-controlled study the subjects will receive 10mg, 20mg and 35mng of PUR1900 every day for a period of 4 weeks. The primary endpoint will be the safety and tolerability of the multiple dose administration while the secondary endpoints will include pharmacokinetics in plasma as well as evaluating the effect of pulmazole in pulmonary function, biomarkers of inflammation, asthma symptoms as well as the burden of aspergillus in sputum.
Study results expected in 2020
Speaking on the progress that the company has made in the second phase study the CEO, Robert Clarke indicated that they were very pleased to get notification that the FDA has completed the IND review for pulmazole. The completion allows the company to proceed with the initial stage of second phase clinical trials of safety and tolerability. The IND is a vital regulatory milestone for the company which reinforces their resolve in bringing premium therapeutic alternatives for asthmatic patients with Allergic Bronchopulmonanry Aspergillosis.
The CEO stated that this was a critical step for the company in the development of pulmazole and bringing the drug to U.S. patients. Top line data for the safety and tolerability study is scheduled for Q2 of 2020.