• 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.

About Allergic Bronchopulmonary Aspergillosis (ABPA)

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.

About the AAPS Journal

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.

About Pulmatrix, Inc.

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: https://www.pulmatrix.com/pipeline.html.

Forward-Looking Statements

Certain statements in this press release that are forward-looking and not statements of historical fact are forward-looking statements within the meaning of the federal securities laws. Such forward-looking statements include, but are not limited to, statements of historical fact and may be identified by words such as "anticipates," "assumes," "believes," "can," "could," "estimates," "expects," "forecasts," "guides," "intends," "is confident that", "may," "plans," "seeks," "projects," "targets," and "would," and their opposites and similar expressions are intended to identify forward-looking statements. Such forward-looking statements are based on the beliefs of management as well as assumptions made by, and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including, but not limited to, the impact of the novel coronavirus (COVID-19) on the Company's ongoing and planned clinical trials; the geographic, social and economic impact of COVID-19 on the Company's ability to conduct its business and raise capital in the future when needed; delays in planned clinical trials; the ability to establish that potential products are efficacious or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development of therapeutic candidates; the ability to obtain appropriate or necessary governmental approvals to market potential products; the ability to obtain future funding for developmental products and working capital and to obtain such funding on commercially reasonable terms; the Company's ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; the ability to secure and enforce legal rights related to the Company's products, including patent protection. A discussion of these and other factors, including risks and uncertainties with respect to the Company, is set forth in the Company's filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K, as may be supplemented or amended by the Company's Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. The Company disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

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