Topigen initiates Phase II proof of concept study in COPD

This new study is expected to provide the first assessment of TPI 1020’s potential activity in COPD.

The trial is a 6-week, multi-center, double blind, placebo and active-controlled study, where about 50 patients with COPD will be randomly allocated to three arms. Each arm will receive inhaled doses of TPI 1020 and budesonide, a conventional corticosteroid commonly used in respiratory disorders, or placebo. Eligible patients will be smokers or ex-smokers between 40 and 80 years old with an established clinical history of mild to moderate COPD as defined by the standards for the diagnosis and management of patients with COPD.

The primary outcome measures of the study are the effect of TPI 1020 and budesonide on the change in sputum neutrophil counts between baseline and day 42 and the safety and tolerability of inhaled TPI 1020 in COPD patients. A secondary outcome will also measure the change in sputum neutrophil counts between baseline and day 21.

Under the terms of the agreement signed between NicOx and Topigen in October 2005, Topigen acquired the development and commercialization rights to TPI 1020 in North America with an option to obtain rights to the rest-of-world from NicOx at a later date.

TPI 1020 is a new chemical entity and novel anti-inflammatory licensed by Topigen from NicOx for COPD and other respiratory disorders.

Pascal Pfister, chief scientific officer at NicOx, said: “The progression of the TPI 1020 program is a testament to Topigen’s expertise in the respiratory therapeutic area, as well as the broad potential of NicOx’ technology, and we see this collaboration as a validation of our strategy of partnering with leading biopharmaceutical companies outside our key therapeutic domains.”