Data from a Phase 1 study of Pulmatrix’s PUR0200 lactose-free dry powder formulation of tiotropium has been published online in the British Journal of Clinical Pharmacology.
The dose-ranging study in patients with moderate-to-severe COPD compared 3 doses of PUR0200 (3 μg, 6 μg, or 9 μg) to Spriva Handihaler (18 μg) and placebo. All doses of PUR0200 produced a statistically significant increase in FEV1 and were well tolerated with no safety issues. The 3 μg dose produced bronchodilation similar to that achieved by Spiriva Handihaler.
Pulmatrix Chief Scientific Officer David Hava commented, “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. 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.”
Pulmatrix is partnered with Vectura on development of PUR0200 for the US market, and the drug will be delivered using Vectura’s DPI device.
Read the Pulmatrix press release.
