The company’s product is a reformulation of tiotropium bromide, the active component in Boehringer Ingelheim’s blockbuster drug, Spiriva.
Pulmatrix used salt-based excipients and spray-drying techniques as part of its iSperse drug-delivery platform to develop a product that it hypothesizes can reach the lungs more efficiently than traditional formulations of tiotropium bromide.
In the Phase I trial published this week, researchers gave patients either one of three doses of Pulmatrix’s PUR0200 product or Spiriva or a placebo. Pulmatrix reported that treatment with PUR0200 at all doses resulted in a statistically significant increase in forced expiratory volume compared to placebo and resulted in similar bronchodilation compared to Spiriva.
The company also noted that the lowest PUR0200 dose achieved similar clinical effects compared with Spiriva.
“The results from this Phase I 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,” David Hava, chief scientific officer, said in prepared remarks. “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,” lead author Dr. Dave Singh added. “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.”