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
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
SOURCE Pulmatrix, Inc.