PULM: Less Drug-Drug Problems w/Inhaled PUR1900

Pulmatrix Announces Publication on Physiologically Based Pharmacokinetic Modelling of Potential Drug-Drug Interactions with PUR1900, Orally Inhaled Itraconazole
PR Newswire

Results demonstrate a low likelihood of clinically meaningful drug-drug interactions when PUR1900 is administered with medications contraindicated with oral itraconazole

Pulmatrix is currently enrolling patients in a Phase 2 study of PUR1900 in adults with ABPA and Asthma

BEDFORD, Mass. , Aug. 23, 2023 /PRNewswire/ -- Pulmatrix, Inc. (NASDAQ: PULM), is a clinical-stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary and central nervous system disease using its patented iSPERSE™ technology. PUR1900 is an orally inhaled dry powder formulation of the antifungal itraconazole, utilizing iSPERSE technology, being developed for the treatment of Allergic Bronchopulmonary Aspergillosis (ABPA) in patients with asthma.


Administration of PUR1900 results in high lung and low systemic itraconazole exposure. Oral itraconazole is a potent inhibitor of cytochrome P450 3A4 (CYP3A4), which alters the metabolism and consequently the plasma concentrations of other drugs metabolized by this pathway. Co-administration of some of these drugs with oral itraconazole is contraindicated due to the potential for drug-drug interactions (DDI).

Pulmatrix today announced publication of "Evaluation of the Potential for Drug ‑ Drug Interactions with Inhaled Itraconazole Using Physiologically Based Pharmacokinetic Modelling, Based on Phase 1 Clinical Data" in the peer-reviewed American Association of Pharmaceutical Scientists (AAPS) Journal.

Dr. Margaret Wasilewski , Chief Medical Officer of Pulmatrix, commented, "We are pleased to publish the drug-drug interaction modeling study on PUR1900 in the AAPS Journal. This study demonstrates the risk of DDI with PUR1900 (inhaled itraconazole) is lower than with oral itraconazole and PUR1900 may be safely administered even in patients taking drugs contraindicated with oral itraconazole."

Ted Raad , Chief Executive Officer of Pulmatrix, commented, "While oral itraconazole is part of the standard of care for patients suffering from ABPA, its use is limited due to the side effects and drug to drug interactions associated with the high itraconazole plasma concentrations of oral itraconazole therapy. PUR1900 has the potential to provide an inhalation alternative to oral antifungal therapy in treating ABPA."

Pulmatrix is conducting a Phase 2 study of PUR1900 in adults with ABPA and asthma with sites in in the United States , Australia , France , and the United Kingdom . Patients with ABPA and asthma can find information about the study at clinicaltrials.gov ( NCT05667662 ).

View the full manuscript on here Pulmatrix's website.

ABPA is an exaggerated response of the immune system to the fungus Aspergillus fumigatus in patients with asthma and cystic fibrosis. Aspergillus , a ubiquitous fungus, colonizes the airways of patients with asthma and cystic fibrosis and triggers an intense inflammatory response that results in worsening symptoms, more frequent exacerbations, and ultimately lung damage. Current treatment for ABPA consists of prolonged courses of oral corticosteroids, and oral antifungal therapy may be added in patients who do not respond adequately to oral corticosteroid therapy alone. Published studies evaluating antifungal agents in patients with ABPA report some improvement including possible reduction in oral corticosteroid use. However, the use of oral antifungal therapy is limited by systemic side effects. ABPA occurs in approximately 1.5% of adult patients with asthma, with about 300,000 affected individuals in the US and approximately 5 million patients worldwide.

The AAPS Journal , an official journal of the American Association of Pharmaceutical Scientists, publishes state-of-the art papers that present innovative and relevant research spanning various areas of the pharmaceutical sciences impacting human and veterinary therapeutics. The premier journals of the American Association of Pharmaceutical Scientists have established a position of leadership among pharmaceutical scientists and successfully disseminate expert, high-quality content to the pharmaceutical sciences community.

Pulmatrix is a clinical-stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary diseases and central nervous system ("CNS") disorders using its patented iSPERSE™ technology. The Company's proprietary product pipeline includes treatments for lung diseases, such as allergic bronchopulmonary aspergillosis ("ABPA"), Chronic Obstructive Pulmonary Disease ("COPD") and CNS disorders such as acute migraine. Pulmatrix's product candidates are based on its proprietary engineered dry powder delivery platform, iSPERSE™, which seeks to improve therapeutic delivery to the lungs by maximizing local concentrations and reducing systemic side effects to improve patient outcomes. For more on our inhaled product candidates please visit: www.pulmatrix.com/pipeline.html .