Itraconazole Inhalation Receives IND Approval for Phase 2 Clinical Trial
Pulmatrix is set to launch a clinical investigation on the product in 2019.
Pulmatrix has received the FDA’s approval for the Investigational New Drug (IND) Application of an inhaled formulation of the antifungal drug itraconazole (Pulmazole [PUR1900]), for Allergic Bronchopulmonary Aspergillosis (ABPA) in patients with asthma, according to the company.
The product is the first inhaled dry powder version of the oral itraconazole, the current adjunctive treatment for ABPA, and is meant to deliver the product directly to the lung, with the goal of improving efficacy and safety.
“[The FDA review of the IND] is a critical step in the progression of Pulmazole to bring the product to patients in the US,” said Robert Clarke, PhD, CEO of Pulmatrix, in a prepared statement.
The biopharmaceutical company’s next step is to launch a Phase 2 clinical investigation for this product, to be initiated within the first half of this year, according to a press release. The study will randomly assign participants into 4 groups of 16 subjects, who will each receive 10 mg, 20 mg, or 35 mg of either Pulmatrix’ itraconazole dry powder inhalation or a placebo, administered once—daily for 28 days.
Clarke said that the FDA’s review of the product’s IND “reinforces Pulmatrix's intention to bring an improved novel therapeutic option to patients suffering from ABPA.”
The purpose of this investigation is to evaluate whether a multiple—dose intake will be safe and tolerable for treating ABPA in adults with asthma, to characterize its pharmacokinetics, and to evaluate its effects on inflammation, pulmonary function, asthma symptoms and aspergillus burden in sputum.
Top line data is expected in 2020.
Pulmatrix Receives IND Approval for Pulmazole Phase 2 Clinical Study [news release]. Lexington, MA; February 7, 2019. PR Newswire. https://www.prnewswire.com/news-releases/pulmatrix-receives-ind-approval-for-pulmazole-phase-2-clinical-study-300791399.html. Accessed February 11, 2019.