Pulmatrix Announces Publication of Results from a Phase 1 Pharmacodynamic Study of PUR0200 in COPD Patients

Data published in the British Journal of Clinical Pharmacology demonstrate that PUR0200 achieves similar improvements in lung function to Spiriva® HandiHaler® at significantly lower doses

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Pulmatrix, Inc.

Jun 13, 2018, 09:35 ET

LEXINGTON, Mass., June 13, 2018 /PRNewswire/ -- Pulmatrix, Inc. (NASDAQ: PULM), a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary diseases announced today the publication of data from a dose-ranging Phase 1 clinical study of PUR0200 in COPD patients. PUR0200 is a once-daily, reformulation of tiotropium bromide for COPD patients and is being developed as a branded alternative to Spiriva® HandiHaler®. The data was published online in the British Journal of Clinical Pharmacology.

PUR0200 combines tiotropium bromide, the active component in the billion-dollar blockbuster drug Spiriva, with Pulmatrix's innovative iSPERSE™ drug delivery platform. iSPERSE utilizes salt based excipients and spray-drying to create particles for inhalation that are intended to improve the delivery of drugs to the lungs compared to lactose-blend dry powders. In the published study, moderate-to-severe COPD patients were administered one of three PUR0200 doses (3mg, 6mg or 9mg tiotropium bromide), Spiriva HandiHaler (18mg tiotropium bromide) or placebo in a 5 period cross-over study design. PUR0200 treatment at all doses resulted in a statistically significant increase in FEV1 compared to placebo and caused similar bronchodilation compared to Spiriva HandiHaler. The lowest PUR0200 dose achieved a similar clinical effect to Spiriva HandiHaler at a dose that was 83% lower and resulted in >30% less plasma drug exposure. The PUR0200 dose was generally safe and well tolerated at all doses compared to Spiriva HandiHaler.

"The results from this Phase 1 clinical study of PUR0200 are the first clinical demonstration of the delivery advantages of the Pulmatrix iSPERSE technology compared to lactose-based dry powder inhalers," said David Hava, Ph.D., Chief Scientific Officer for Pulmatrix. "The ability to achieve similar lung deposition and clinical improvement at reduced exposure to patients highlights the potential of iSPERSE to enable differentiated versions of existing products and to enable new products for the treatment of respiratory disease."

"Tiotropium is a widely prescribed bronchodilator used in the management of COPD, often delivered as a dry powder using Spiriva HandiHaler," said Dave Singh, MD, Professor of Clinical Pharmacology and Respiratory Medicine at the University of Manchester, principle investigator on the study and lead author on the paper. "The clinical data published in the British Journal of Clinical Pharmacology highlight the delivery advantages of PUR0200 and the potential to achieve clinically meaningful improvements in pulmonary function at reduced doses. In the future, the iSPERSE technology has the potential to enable new formulations of bronchodilators or novel drugs for the treatment of COPD."

In September of last year, Pulmatrix announced that it has partnered with Vectura Group plc (LSE: VEC) ("Vectura") to develop PUR0200 for the U.S. market. Vectura intends to utilize its innovative dry power inhaler device technology to deliver PUR0200, with the goal of providing enhanced delivery and a better device format of PUR0200 for patients.

Link to the abstract for the manuscript: https://bpspubs.onlinelibrary.wiley.com/doi/10.1111/bcp.13645

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 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.