The trial, which started in February, is focusing on pulmazole’s safety and patients’ ability to tolerate it. Pulmatrix expects the results to be good enough to start a Phase 2a trial in the fourth quarter of 2018.
“The Company continues to advance its iSPERSE-based product candidates,” Robert W. Clarke, the CEO of Pulmatrix, said in a press release. “We expect Phase 1b data in mid-2018 on Pulmazole targeting fungal infections for severe asthma and cystic fibrosis patients.”
Pulmatrix said the Phase 1/1b study, which is being conducted in the United Kingdom, is expected to include up to 42 healthy volunteers. They will receive single or multiple ascending doses of pulmazole to assess its safety, tolerability, and stability in the body.
The study will also include about 16 people with mild to moderate stable asthma. They will receive either a single dose of oral Sporanox (200 mg itraconazole) or inhaled Pulmazole (20 mg itraconazole).
“Dosing our first subject with Pulmazole and entering the clinic [clinical trials] represents a major milestone for this program,” Jim Roach, the chief medical officer of Pulmatrix, said in another press release.
Results from the trial are expected to corroborate previous preclinical-trial findings that a higher concentration of pulmazole is able to enter the lungs to fight fungus, compared with Sporanox, Roach added. In addition, the inhaled treatment has less effect on the rest of the body, researchers said. Preclinical-trial studies also suggested pulmazole may increase survival.
The Cystic Fibrosis Foundation Therapeutics has been supporting the research.
Pulmazole, formerly known as PUR1900, combines itraconazole’s anti-fungal activity with Pulmatrix’s dry-powder delivery technology platform iSPERSE — which stands for inhaled small particles easily respirable and emitted.
Pulmatrix believes pulmazole could also be used to fight allergic bronchopulmonary aspergillosis in patients with lung diseases.
Aspergillosis is caused by airway infections of the fungus Aspergillus fumigatus. It is estimated to affect about 15% of patients with CF, and is associated with severe exacerbations and poor long-term outcomes.
Pulmazole has received orphan drug status and a Qualified Infectious Disease Product (QIDP) designation from the U.S. Food and Drug Administration. The designations support the drug’s development and protect the company’s right to market it.