Clinical stage biotechnology company Pulmatrix has started Phase IB clinical study of a bronchodilator therapy, PUR0200, for chronic obstructive pulmonary disease (COPD).
PUR0200 is a small molecule product that leverages the company's novel inhaled dry powder delivery platform iSPERSE technology, which facilitates flow-rate independent high-efficiency drug delivery to the lungs.
Pulmatrix chief scientific officer Dr David Hava said PUR0200 has demonstrated good performance in preclinical evaluation models of airway bronchoconstriction.
"The engineered aerosol performance and delivery characteristics of the iSPERSE platform are expected to result in PUR0200 efficacy at low doses," Hava said.
GOLD Stage 2/3 COPD patients will be enrolled in the trial, which is designed to assess the safety tolerability and the pharmacokinetic/pharmacodynamic profile besides PUR0200 dose response.
The five-way placebo controlled crossover study is being conducted by Quotient Clinical in Nottingham England in conjunction with the Medicines Evaluation Unit in Manchester England.
Quotient Clinical will use the flexible translational pharmaceutics platform to manufacture and supply the drug product.
Pulmatrix chief executive officer Dr Robert Clarke said: "We are hopeful that PUR0200 will be the first step in the establishment of a new generation of easily inhaled easy-to-use therapeutics based on the iSPERSE technology to serve COPD asthma Cystic Fibrosis and other patients suffering from respiratory disease."
The company expects to present the results in 2014.
Image: A chest X-ray demonstrating severe COPD. Note the small size of the heart in comparison to the lungs. Photo: courtesy of James Heilman.