FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits

MHRA Clears Trial for Inhaled Pulmazole

Jan. 26, 2018

The UK’s Medicines and Healthcare Products Regulatory Agency signed off on Pulmatrix’s first-in-human study for an inhaled formulation of intraconazole.

The company will enroll 42 patients in a Phase I study to assess its drug Pulmazole’s safety and tolerability in patients with mild to moderate stable asthma. The inhaled formulation would be indicated for allergic bronchopulmonary aspergillosis.

Pulmatrix expects top-line results from the study by mid-2018. The company has already begun screening subjects, according to chief medical officer James Roach.

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