Pulmatrix Receives IND Approval for Pulmazole Phase 2 Clinical Study

Pulmatrix announced the US Food and Drug Administration (FDA) completed its review of our Investigational New Drug (IND) Application and notified the Company that we are authorized to initiate a Phase 2 clinical investigation for Pulmazole (PUR1900) – an inhaled iSPERSETM formulation of the anti-fungal drug itraconazole for the treatment of allergic bronchopulmonary aspergillosis (ABPA) in patients with asthma.

With the IND effective, the Company plans to initiate a study in the first half of 2019 entitled: "A Randomized, Double-Blind, Multicenter, Placebo-Controlled, Phase 2 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Itraconazole Administered as a Dry Powder for Inhalation (PUR1900) in Adult Asthmatic

Patients with Allergic Bronchopulmonary Aspergillosis". Enrolled subjects will be randomly assigned (1:1:1:1) into 4 arms of 16 subjects each (n=64 total) and will receive 10 mg, 20 mg, or 35 mg of PUR1900 or placebo, administered via once daily dry powder inhalation daily for 28 days. The primary objective of the study is to evaluate the safety and tolerability of multiple-dose administration of PUR1900 given to adult asthmatic subjects with ABPA. Secondary objectives include characterizing the pharmacokinetics of multiple dose administration of inhaled PUR1900 in plasma and sputum, as well as evaluating the effect of PUR1900 on relevant biomarkers of inflammation, pulmonary function (FEV1), asthma symptoms, and aspergillus burden in sputum. Top line data is expected in the second quarter of 2020.

"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," said Robert Clarke, PhD, Pulmatrix CEO.

ABPA is a disease that occurs most often in patients with underlying asthma or cystic fibrosis, and it is characterized by an exaggerated allergic hypersensitivity response of the immune system to the fungus Aspergillus colonizing and growing in the airways. Oral itraconazole (Sporanox) is currently used as an adjunctive treatment to corticosteroids in ABPA patients. However, its use is limited by poor bioavailability, variable pharmacokinetics, and toxicity concerns related primarily to the risk of gastrointestinal and cardiac side effects, as well as extensive drug-drug interactions. The Pulmatrix Pulmazole program is the first inhaled dry powder version of itraconazole known to the company to be advanced into clinical development, with the goal of improving upon the known safety and efficacy profile associated with oral Sporanox by delivering the drug directly to the lung.

Pulmatrix is a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary disease using its patented iSPERSE technology. The Company's proprietary product pipeline is focused on advancing treatments for serious lung diseases, including Pulmazole, inhaled anti-fungal itraconazole for patients with ABPA, and PUR1800, a narrow spectrum kinase inhibitor for patients with obstructive lung diseases including asthma and chronic obstructive pulmonary disease (COPD). Pulmatrix's product candidates are based on iSPERSE, its proprietary engineered dry powder delivery platform, which seeks to improve therapeutic delivery to the lungs by maximizing local concentrations and reducing systemic side effects to improve patient outcomes.

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