Press Releases

LEXINGTON, Mass., July 23, 2018 /PRNewswire/ -- Pulmatrix, Inc. (NASDAQ: PULM), a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary diseases announced today the formation of the Clinical Advisory Board (CAB) for Pulmazole (PUR1900) – an inhaled iSPERSE™ formulation of the anti-fungal drug itraconazole for the treatment of allergic bronchopulmonary aspergillosis (ABPA) in patients with asthma.  The members of the CAB are world-renowned experts in the fields of both ABPA and asthma and will work closely with Pulmatrix to design and implement future clinical studies of Pulmazole. 

"I am very encouraged by the Phase 1 results demonstrating that it is both feasible to administer itraconazole by inhalation and further that high levels of the drug may be achieved within the airways," stated Dr. David Denning, Professor of Infectious Diseases in Global Health and the Director of the National Aspergillosis Centre, Manchester, UK, and co-chair of the Pulmazole CAB.  "I believe that Pulmazole has the potential to significantly improve upon both the efficacy and safety profile of oral Sporanox, and I look forward to working with the other members of the advisory board to assist Pulmatrix in advancing the development of Pulmazole to treat patients with fungal asthma, focusing initially on ABPA."     

The members of the Pulmazole Clinical Advisory Board are as follows:

Co-Chairs:

David Denning, FRCP, FRCPath, FIDSA, FMedSci - Professor of Infectious Diseases in Global Health; President, Global Action Fund for Fungal Infections; Director, National Aspergillosis Centre, Manchester, UK

Jim Roach, MD, FACP, FCCP – Chief Medical Officer, Pulmatrix

Members:

Ritesh Agarwal, MD, DM - Professor of Pulmonary Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, India

William J Calhoun, MD - Professor and Vice Chair for Research, Divisions of Pulmonary, Critical Care and Sleep, and Allergy/Immunology.  Department of Medicine at University of Texas Medical Branch, Galveston, TX

Mario Castro, MD, MPH, FCCP - Professor of Medicine, Pediatrics, and Radiology, Division of Pulmonary and Critical Care Medicine at the Washington University School of Medicine in St. Louis, MO

Jonathan Corren, MD - Associate Clinical Professor of Medicine and Pediatrics, David Geffen School of Medicine at UCLA, Los Angeles, CA

Cendrine Godet, MD - Doctor of Infectious Diseases and Pulmonary Medicine at Poitiers University Hospital, France; Coordinator of the French National Board for Chronic Fungal Infection and Secretary of the European CPAnet Board for Chronic Pulmonary Aspergillosis

Richard B. Moss, MD - Professor Emeritus, Pediatrics-Pulmonary Medicine at Stanford University School of Medicine, Stanford, CA

Russell Settipane, MD - Clinical Professor of Medicine at Brown Medical School, Director of the Allergy & Asthma Center, Providence, RI; Associate Editor of Allergy & Asthma Proceedings and the Journal of Precision Respiratory Medicine, President Eastern Allergy and Eastern Pulmonary Conferences

David A. Stevens, MD, FACP, FAAM, FIDSA Professor Emeritus, Infectious Diseases and Geographic Medicine at Stanford University School of Medicine, Stanford, CA; President, California Institute for Medical Research, San Jose, CA

Peter Wark, BMed PhD FRACP FThorSoc - Conjoint Professor, Centre for Healthy Lungs, University of Newcastle & Department of Respiratory and Sleep Medicine John Hunter Hospital, New Lambton NSW, Australia

Michael Wechsler, MD, MMSc - Professor of Medicine, Director, NJH Cohen Family Asthma Institute, Department of Medicine, National Jewish Health, Denver, CO

Additional background on the CAB members can be found on the Pulmatrix website.

"With the successful completion of our Phase 1/1b Pulmazole trial, we are excited to move on to our planned Phase 2 trial in the fourth quarter of this year utilizing a study design informed by the expertise of our Clinical Advisory Board. The insight and expertise provided by our advisors will be critical as we advance the development of Pulmazole in ABPA, and we are honored and extremely fortunate to welcome such distinguished clinicians to the team," stated Jim Roach, MD, Chief Medical Officer of Pulmatrix.

About ABPA
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.  Third party research sponsored by Pulmatrix suggests that physician use of antifungals, with oral steroids, may more than double with the introduction of an inhaled itraconazole.  This highlights the significant unmet need for new safe and effective antifungal therapies to treat asthmatic patients with ABPA.

About Pulmatrix
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"). In addition, Pulmatrix has partnered with Vectura Group plc to develop Pulmatrix's long-acting muscarinic antagonist drug candidate, PUR0200, for COPD for the U.S. market. 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. 

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 safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The Company cautions that such statements involve risks and uncertainties that may materially affect the Company's results of operations. 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 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 Securities and Exchange Commission, including its annual report on Form 10-K filed by the Company with the Securities and Exchange Commission on March 13, 2018, 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.

SOURCE Pulmatrix, Inc.