Phase 2 clinical trial initiated and enrollment progressing across 24 sites
Study to support proof-of-concept mechanism with top line data expected mid-2020
LEXINGTON, Mass., Sept. 18, 2019 /PRNewswire/ -- Pulmatrix, Inc. (PULM) today announced that the first patient has been dosed in the Phase 2 trial evaluating Pulmazole, an inhaled iSPERSE formulation of the antifungal itraconazole in development for the treatment of Allergic Bronchopulmonary Aspergillosis (ABPA) in patients with asthma. The randomized, double-blind, placebo-controlled trial will evaluate the efficacy and safety of three dose levels of Pulmazole administered daily for 28 days in approximately 64 patients.
"Building upon the Phase 1 results, in which Pulmazole achieved greater drug concentrations in the lung with much lower plasma concentrations than oral Sporanox at 1/10th the dose, the dosing of our first Phase 2 Study patient is an important milestone," said Ted Raad, chief executive officer of Pulmatrix. "We believe that Pulmazole has the potential to change the standard of care for patients with ABPA and asthma by providing a treatment option that prevents the dose-limiting side effects seen with oral antifungal treatments and improves upon the known efficacy of oral itraconazole by delivering significantly more drug to the lungs than can be achieved with oral dosing."
The Phase 2 study is a global, multicenter, 4 arm trial. 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 Pulmazole 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 Pulmazole given to adult subjects with asthma and ABPA. Secondary objectives include characterizing the pharmacokinetics of multiple dose administration of inhaled Pulmazole in plasma and sputum, as well as evaluating the effect of Pulmazole on relevant biomarkers of inflammation, pulmonary function (FEV1), asthma symptoms, and aspergillus burden in sputum.
About Allergic Bronchopulmonary Aspergillosis (ABPA)
Allergic bronchopulmonary aspergillosis (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 is added in patients who do not respond adequately to oral corticosteroid therapy alone. Published studies evaluating antifungal agents in patients with ABPA report some degree of improved disease control leading to the reduction of oral corticosteroid dose. However, the use of oral antifungal therapy is limited by systemic side effects and poor bioavailability in the airways. ABPA is estimated to occur in approximately 1.5% of adult patients with asthma, with about 300,000 affected individuals in the US and approximately 5 million patients with asthma worldwide.
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, an inhaled anti-fungal for patients with allergic bronchopulmonary aspergillosis ("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.
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 safe harbor provisions of the Private Securities Litigation Reform Act of 1995. 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, 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; and 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 SEC, including its annual report on Form 10-K filed with the Securities and Exchange Commission on February 19, 2019, as amended on July 24, 2019, as may be supplemented or amended by the Company's Quarterly Reports on Form 10-Q. 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.
Ted Raad, CEO
William Duke, CFO
View original content to download multimedia:http://www.prnewswire.com/news-releases/pulmatrix-and-cipla-announce-first-patient-dosed-in-phase-2-trial-evaluating-pulmazole-for-treatment-of-allergic-bronchopulmonary-aspergillosis-in-patients-with-asthma-300920023.html