Pulmatrix secures FDA approval for Pulmazole phase 2 clinical study
Pulmazole phase 2 clinical study : Pulmatrix said that the US Food and Drug Administration (FDA) has authorized the Massachusetts-based
The post Pulmatrix secures FDA approval for Pulmazole phase 2 clinical study appeared first on PharmaNewsDaily.com.
Pulmazole phase 2 clinical study : Pulmatrix said that the US Food and Drug Administration (FDA) has authorized the Massachusetts-based biopharma company to begin a phase 2 clinical trial for Pulmazole (PUR1900), for the treatment of allergic bronchopulmonary aspergillosis (ABPA) in patients with asthma.
This was after the US drug regulator completed its review of the company’s Investigational New Drug (IND) application for the respiratory drug candidate.
Pulmazole is aninhaled iSPERSE formulation of the anti-fungal drug itraconazole. Its phase 2 clinical trial in ABPA is planned to be initiated in the first half of this year
Commenting on the phase 2 trial of PUR1900 aka Pulmazole, Robert Clarke – CEO of Pulmatrix, said: “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.”
Enrolled patients for the planned Pulmazole phase 2 clinical study will be randomly grouped into four arms of 16 subjects each to be subjected to 10 mg, 20 mg, or 35 mg of the drug or placebo, administered via daily once dry powder inhalation daily for a period of 28 days.
The primary goal of the mid-stage trial is to assess the safety and tolerability of multiple-dosage of PUR1900 to adult asthmatic patients with ABPA.
Secondary objectives of the phase 2 trial are characterizing the pharmacokinetics of multiple dose administration of inhaled PUR1900 in plasma and sputum, assessing the effect of PUR1900 on relevant biomarkers of inflammation, pulmonary function (FEV1), asthma symptoms, and aspergillus burden in sputum.
Top line data from the Pulmazole phase 2 clinical study is anticipated to come out in the second quarter of 2020.
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