Revotar Biopharmaceuticals AG today 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.
"Inhaled Bimosiamose solution previously demonstrated to be safe and anti-inflammatory in short-term trials with healthy subjects (ozone challenge) and in patients with Asthma and COPD," said Prof Wolfgang Meyer-Sabellek, Chief Medical Officer of Revotar. "We are now looking forward to confirm and extend this encouraging potential on the basis of longer treatment and more COPD outpatients."
"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."
About COPD
Chronic Obstructive Pulmonary Disease (COPD) comprises several serious conditions affecting the lung. According to the WHO, COPD is affecting more than 210 million people worldwide, of which about 80 million people suffer from moderate to severe forms of the disease. More than 3 million people died of COPD in 2005, which corresponds to 5% of all deaths globally. The WHO predicts that COPD will become the third leading cause of death worldwide by 2030. In 2009, the global COPD market recorded sales of approximately 10 billion US-$.
Source: Revotar Biopharmaceutical AG
