PUR0200 is an iSPERSE formulation with a well-known long-acting muscarinic antagonist (LAMA) bronchodilator, tiotropium bromide. iSPERSE is a dry powder delivery technology also being developed by Pulmatrix to improve delivery of inhaled compounds to the lungs.
PUR0200 studies for the treatment of COPD
A Phase 1 study (NCT01921712) assessed the pharmacokinetics, pharmacodynamics, safety and tolerability of PUR0200 in 38 COPD patients. Participants were divided into five groups, and given either one of the three doses of PUR0200 (3, 6 or 9 mcg), placebo, or tiotropium 18 mcg (Spiriva Handihaler). Pharmacokinetics and trough FEV1 were measured just before the treatment and 24 hours after treatment.
It was well-tolerated and the adverse events reported were mild, researchers reported. PUR0200 9 mcg showed a 4.5 times higher lung dose of tiotropium than tiotropium 18 mcg. Lung function, as measured by trough FEV1, improved significantly with all doses when compared to placebo and was similar to tiotropium 18 mcg. These results, reported in The European Respiratory Journal in a 2015 article, showed that PUR0200 treatment achieves similar results as tiopropium 18 mcg but at significantly lower doses, meaning that the iSPERSE technology may bring delivery advantages for these medicines.
Another Phase 1 study (NCT02671825) in healthy adults compared blood levels of multiple formulations of PUR0200 to an unidentified other inhaled treatment. Five different formulations were tested, and drug blood levels were measured at different treatment times and adverse events recorded. In total, 42 people were divided in seven groups, and given a single dose of one of five different formulations or the reference product in a seven-period crossover study design.
Pulmatrix reported that results of this pharmacokinetic bioequivalence study showed that PUR0200 blood levels were identical across the different doses tested, with increases in exposure proportional to the dose. The safety profile was similar to the reference product, and there were no adverse events.
The company announced that it is planning further clinical testing of this potential COPD treatment, being currently advanced in Europe with plans for a development program in the U.S.
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