Pulmazole phase 2 clinical study gets FDA approval for Pulmazole in allergic bronchopulmonary aspergillosis

Pulmatrix, the Massachusetts-based biopharmaceutical company, has received approval from the US Food and Drug Administration (FDA) to initiate a phase 2 clinical trial for Pulmazole (PUR1900). This drug candidate is targeted at treating allergic bronchopulmonary aspergillosis (ABPA) in patients with asthma. The approval follows a successful review of Pulmatrix’s Investigational New Drug (IND) application by the FDA.

Pulmazole is an inhaled formulation of the antifungal drug itraconazole, designed using the company’s proprietary iSPERSE technology. The upcoming phase 2 trial marks a critical step toward advancing Pulmazole’s development and is expected to start in the first half of the year.

CEO’s Statement on Pulmazole’s Progress

Robert Clarke, CEO of Pulmatrix, expressed his enthusiasm about the trial’s progress, stating: “We are very pleased that the FDA review of the IND is complete, allowing us to proceed, and this important regulatory milestone reinforces Pulmatrix’s intention to bring an improved novel therapeutic option to patients suffering from ABPA. This is a critical step in the progression of Pulmazole to bring the product to patients in the US.”

Details of the Phase 2 Trial

The phase 2 trial will include a randomised selection of patients with asthma and ABPA, with each subject receiving one of four possible treatments: 10 mg, 20 mg, or 35 mg doses of Pulmazole or a placebo. The drug will be administered via a once-daily dry powder inhaler over a 28-day period.

The trial’s primary objective is to evaluate the safety and tolerability of multiple doses of PUR1900 in adult asthma patients suffering from ABPA. Secondary objectives include understanding the drug’s pharmacokinetics in both plasma and sputum, its effects on biomarkers of inflammation, pulmonary function (FEV1), asthma symptoms, and its impact on the aspergillus burden in sputum.

Expected Data Release

The top-line data from the Pulmazole phase 2 study is expected to be released in the second quarter of 2020. This data could provide critical insights into the viability of Pulmazole as a treatment option for patients with ABPA, potentially advancing the drug to the next stages of development.