LEXINGTON, Mass., Feb. 1, 2016 /PRNewswire/ -- Pulmatrix, Inc. (NASDAQ: PULM) reports that enrollment is underway in the Company's European pilot bioequivalence study of PUR0200, a proprietary iSPERSE™ (Inhaled Small Particles Easily Respirable and Emitted) engineered dry powder formulation of a marketed long acting muscarinic antagonist (LAMA) bronchodilator for the treatment of chronic obstructive pulmonary disease (COPD). Enrollment is expected to be completed in the first quarter of 2016 and topline results are expected to be reported in the second quarter of 2016.
The trial is a seven-period crossover study in 42 healthy volunteers. The trial will evaluate pharmacokinetics (PK) and safety and tolerability of five unique PUR0200 formulations compared to two dosing periods of a marketed reference product. The five unique PUR0200 formulations vary in aerosol properties and strength. PUR0200 is being developed under the PK bioequivalence regulatory pathway for orally inhaled drugs in Europe.
"Our goal for the trial is to identify a PUR0200 candidate to advance to a pivotal PK bioequivalence trial in collaboration with our development partner," said David Hava, Chief Scientific Officer for Pulmatrix. "Upon completion of the trial, we expect to define formulation parameters that will allow us to establish a PK match to the reference product through intelligent formulation design with iSPERSE™. Based on the properties of our iSPERSE™ platform, we believe we will be able to achieve similar distribution of the active pharmaceutical ingredient in the lungs and throughout the body (PK) at a fraction of the dose compared to the reference product."
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 rare diseases, including PUR1900, an inhaled anti-fungal for patients with cystic fibrosis (CF), as well as PUR1500, an inhaled product for the treatment of idiopathic pulmonary fibrosis. In addition, Pulmatrix is pursuing opportunities in major pulmonary diseases through collaborations, including PUR0200, a branded generic in clinical development for chronic obstructive pulmonary disease (COPD). 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.
Pulmatrix's iSPERSE™technology has the potential to solve significant limitations of other inhaled technologies available today, such as nebulizers, metered dose inhalers, and conventional lactose blend dry powder inhalers. iSPERSE™ particles are engineered to be small, dense, and easily dispersible upon inhalation, thereby delivering the drugs more efficiently to the airways. This targeted airway delivery of drugs also reduces systemic exposure and potential side effects. Importantly, unlike other traditional inhalation technologies, iSPERSE™ is also flow rate independent, which should provide reliable dose delivery across patient populations regardless of the status of patient lung function.
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 most recent quarterly report on Form 10-Q filed by the Company with the Securities and Exchange Commission. 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.