Revotar Biopharmaceuticals AG Starts Phase II Clinical Trial in COPD Patients with inhaled Bimosiamose

14-Jun-2010 - Germany

Revotar Biopharmaceuticals AG announced the start of a Phase II study to evaluate the safety and efficacy of inhaled Bimosiamose, a pan-selectin antagonist, for the treatment of patients with chronic obstructive pulmonary disease (COPD).

The trial is designed as a double-blind, placebo controlled, randomized, cross-over study comprising up to 60 non-smoking patients with moderate to severe COPD (GOLD II-III). Each subject will receive nebulized Bimosiamose solution or vehicle for 28 consecutive days twice daily in two subsequent periods according to a randomization plan and separated by a wash-out phase (cross-over). Co-alternative primary endpoints will be the difference of neutrophils counts and interleukin-8 levels in induced sputum following Bimosiamose and Placebo; secondary variables cover lung function parameters as well as cellular and non-cellular biomarkers. The study is conducted at 10 centers in Germany.

"There is a huge market need for efficacious and safe anti-inflammatory drugs in COPD considering the reported limited efficacy of inhaled corticosteroids (ICS) or even documented ICS resistance in COPD", added Dr Martin Pöhlchen, CEO of Revotar.

In contrast to oral PDE4 inhibitors, Bimosiamose is given locally by inhalation, directly targeting the inflammation in the lung. In recent assessments from regulatory authorities (e.g. IQWiG) inhalative treatment is preferred towards oral treatment in COPD, since better efficacy and faster onset may be achieved with less systemic side effects. Results are expected for the second quarter of 2011."

https://www.bionity.com/en/news/118840/revotar-biopharmaceuticals-ag-starts-phase-ii-clinical-trial-in-copd-patients-with-inhaled-bimosiamose.html