The clinical stage biopharmaceutical Pulmatrix, recently announced the completion of a pilot study to access the pharmacokinetics of PUR0200 for maintenance treatment of bronchospasms in patients with chronic obstructive pulmonary disease (COPD).
The testing of PUR0200, a dry powdered generic of a once-daily, long-acting muscarinic antagonist, was done using healthy volunteers.
In Europe, PUR0200 development is focused on showing that the drug is bioequivalent to an already marketed product.
The study is grounded on pharmacokinetic data gathered in a previously completed Phase 1b study of PUR0200 in patients with moderate-to-severe COPD. Pharmacokinetics refers to how a medicine makes its way through the human body.
The newly completed seven-way crossover study successfully defined the relationship of PUR0200 formulation characteristics and its pharmacokinetic profile after the administration of single doses at each dosing interval, in order to determine the parameters for further development.
“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,” said Pulmatrix’s Chief Scientific Officer David Hava, in a press release.
Data from the study was presented at a European Respiratory Society meeting in September 2015. A complete analysis is still underway.
“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,” Hava said.
Pulmatrix’s proprietary pipeline is mainly focused on treatments for lung diseases: PUR0200, for COPD, and PUR1900, an inhaled antifungal that could help patients with severe asthma and cystic fibrosis (CF).
The drug candidates are based on Pulmonatrix’s iSPERSE technology, a dry powder delivery platform seeking to improve therapeutic delivery to the lungs by optimizing local concentrations and reducing systematic adverse reactions.
According to the World Health Organization (WHO), in 2004 nearly 65 million people were reported with COPD. By 2020, COPD will likely be the third leading cause of death worldwide.
COPD is a long-term, progressive, aggressive, life-threatening disease of lungs. The most common cause is cigarette smoking. The condition eventually compromises whole body function and the patient’s overall quality of life.