Pulmatrix opens three Phase 2 clinical trial sites for inhaled anti-fungal
Pulmatrix (NASDAQ:PULM) activated three U.S. sites for its Phase 2 clinical trial of pulmazole for the treatment of allergic bronchopulmonary aspergillosis (ABPA) in patients with asthma.
The primary objective of the study is to evaluate the safety and tolerability of pulmazole, an inhalable formulation of the anti-fungal drug itraconazole, in adult asthmatic subjects with ABPA. Subjects will be randomly assigned to receive either 10 mg, 20 mg, or 35 mg of pulmazole – or placebo – administered once daily for 28 days.
The study has been approved in the U.S., U.K. and Australia, in which Plumatrix has 17 treatment sites. The company is pursuing regulatory approval for the trial in India and Poland, in which to establish an additional eight treatment sites.
"With our clinical advisory board of ABPA experts, we developed a meaningful clinical trial that will help inform the treatment of this debilitating disease and further advance the pulmazole program," Ted Raad, Pulmatrix's chief executive officer, said in a statement.
The three activated sites are able to recruit, screen and enroll patients. Plumatrix expects to report topline data from the trial in mid-2020.