Pulmatrix Completes Dosing in Pilot Pharmacokinetic Evaluation of PUR0200 in Healthy Normal Volunteers
PUR0200, a once-daily long acting muscarinic antagonist bronchodilator formulation, was given to healthy volunteers to measure pharmacokinetics and to test for safety.
LEXINGTON, Mass., May 25, 2016 /PRNewswire/ -- Pulmatrix (NASDAQ:PULM), a specialty pharmaceutical company developing novel inhaled therapeutic formulations based on the company's proprietary iSPERSE™ technology, has completed a pilot pharmacokinetic study of PUR0200 in healthy volunteers (HNV). PUR0200 is a dry powder, branded generic of a once-daily of a long-acting muscarinic antagonist (LAMA) for the maintenance treatment of bronchospasm in patients with chronic obstructive pulmonary disease (COPD). Development of PUR0200 in Europe is focused on demonstrating bioequivalence between PUR0200 and a currently marketed product.
The completed 7-way crossover design study aimed at defining the relationship of PUR0200 formulation characteristics and the pharmacokinetic profile of the drug following single doses at each dosing interval to establish formulation parameters for further development towards formal bioequivalence. The current study builds on pharmacokinetic data collected in a previously completed Phase 1b study of PUR0200 in moderate-to-severe COPD patients. Data from the Phase 1b study was presented at the European Respiratory Society meeting in September 2015. Data analysis for the current study is ongoing.
David Hava, PhD, CSO of Pulmatrix, said: "The completed study should significantly expand on our understanding of PUR0200 and the reference product pharmacokinetics. We expect to share top line results of the study in the near future."
Dr Hava added, "Our progress in completing subject recruitment and all clinical procedures is a significant achievement for Pulmatrix staying on time and budget with our publicly disclosed development plans for PUR0200."
COPD is a long term, progressively destructive and life-threatening disease of the lungs. Cigarette smoking is the most common cause of COPD. Performance of everyday activities may be severely curtailed and overall quality of life significantly impaired. The most common symptoms of COPD are breathlessness, production of abnormal mucus in the airway, and a chronic cough. COPD is not curable, but treatment ameliorates symptoms and may slow the progress of the disease. According to the World Health Organization, approximately 65 million people worldwide had COPD in 2004 and it is predicted to become the third leading cause of death by 2020.
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 lung diseases, including opportunities in major pulmonary diseases through collaborations, like PUR0200, a branded generic in clinical development for chronic obstructive pulmonary disease (COPD) and PUR1900, an inhaled antifungal that could benefit severe asthmatics and patients with rare disease like cystic fibrosis. Pulmatrix's product candidates are based on iSPERSE™, its proprietary 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. 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 annual report on Form 10-K filed by the Company with the Securities and Exchange Commission on March 10, 2016. 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.
Robert Clarke, CEO
William Duke, CFO
Chris Brinzey, Westwicke Partners
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