The 64-patient study is a randomized, double-blinded, placebo-controlled trial to evaluate the safety and efficacy of three dose levels of the anti-fungal drug itraconazole formulation Pulmazole.
The multi-center, four-arm trial will be randomized to receive 10mg, 20mg or 35mg of Pulmazole or placebo, administered by dry powder inhalation once daily. The study’s primary objective is to evaluate the safety and tolerability of Pulmazole in adult subjects with asthma and ABPA.
Pulmatrix won the FDA nod to conduct the trial in February, then partnered with Cipla Technologies to co-develop and commercialize the inhaled iSperse formulation of the anti-fungal drug in April. The Cipla deal was worth $22 million upfront for Lexington, Mass.-based Pulmatrix.
“Building upon the Phase I results, in which Pulmazole achieved greater drug concentrations in the lung with much lower plasma concentrations than oral Sporanox at ⅒th the dose, the dosing of our first Phase II study patient is an important milestone,” CEO Ted Raad said in prepared remarks. “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 anti-fungal 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.”
PULM shares were up 1.5% at 87¢ apiece in early-morning trading today.