Pulmatrix, a biotechnology company developing inhalable formulations using its patented iSPERSE technology for patients affected by severe pulmonary abnormalities, recently announced that the company will be reporting key data from a phase IB clinical trial that was designed to help determine the efficacy of their novel pipeline drug PUR0200. The findings are to be presented on September 29th at the European Respiratory Society Congress.
Chemically, PUR0200 is an iSPERSE formulation of a long acting muscarinic antagonist (LAMA) bronchodilator, currently being developed under the PK bio-equivalence pathway in Europe. The phase IB study was a two-part, single dose, placebo controlled dose-ranging clinical trial involving a study population of 38 patients that evaluated the pharmacokinetics (PK), pharmacodynamics (PD) and safety and tolerability of PUR0200 in comparison to a reference product, a once daily LAMA bronchodilator.
The main phase of the study was divided into a sequence of 5 phases with each patient receiving 3, 6, and 9 micrograms of PUR0200, 18 micrograms of the reference product, and an inhalation of placebo. PK results showed that administration of PUR0200 resulted in a proportional increase of the dose in plasma drug levels and all doses of PUR0200 were successful in improving pulmonary function in comparison to the placebo. Apart from all doses being well tolerated by all patients, the study also highlighted the efficiency of the iSPERSE technology when inhaling the 3 microgram doses of PUR0200, which brought about similar PK and PD values as the reference at a nominal dose that is 80% less than the reference product.
The data from the trial will be presented in full by the study’s lead investigator Dr. David Singh from the University of Manchester, UK, at 12:50 p.m. CET, along with additional findings being presented by Dr. David Hava, Ph.D., Chief Scientific Officer of Pulmatrix in a poster presentation.
PUR0200 is being developed for the treatment of COPD. The company believes that the therapy’s unique feature is that because nearly all of the dose reaches the site of action in the lungs, it can offer the same efficacy as other similar therapies at 20% of the dose administered.