Pulmatrix (PULM), Cipla Report First Patient Dosed in Phase 2 Trial Evaluating Pulmazole for Treatment of Allergic Bronchopulmonary Aspergillosis

Pulmatrix, Inc. (NASDAQ: PULM) today announced that the first patient has been dosed in the Phase 2 trial evaluating Pulmazole, an inhaled iSPERSE formulation of the antifungal itraconazole in development for the treatment of Allergic Bronchopulmonary Aspergillosis (ABPA) in patients with asthma. The randomized, double-blind, placebo-controlled trial will evaluate the efficacy and safety of three dose levels of Pulmazole administered daily for 28 days in approximately 64 patients.

"Building upon the Phase 1 results, in which Pulmazole achieved greater drug concentrations in the lung with much lower plasma concentrations than oral Sporanox at 1/10th the dose, the dosing of our first Phase 2 Study patient is an important milestone," said Ted Raad, chief executive officer of Pulmatrix. "We believe that Pulmazole has the potential to change the standard of care for patients with ABPA and asthma by providing a treatment option that prevents the dose-limiting side effects seen with oral antifungal treatments and improves upon the known efficacy of oral itraconazole by delivering significantly more drug to the lungs than can be achieved with oral dosing."

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 once daily dry powder inhalation 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.

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