Revotar Biopharmaceuticals AG today announced positive top-line results on a multi-center Phase II study to evaluate the safety and efficacy of inhaled Bimosiamose for the treatment of patients with chronic obstructive pulmonary disease (COPD).
In a double-blind, placebo controlled, randomized, cross-over study, patients with moderate to severe COPD (GOLD II-III) inhaled Bimosiamose solution or vehicle for 28 consecutive days twice daily in two subsequent periods separated by a wash-out phase (cross-over). Cellular and non-cellular markers of induced sputum collected pre-/post treatment were analyzed. The study, conducted at 11 specialized centers in Germany, enrolled 77 patients.
Inhalation of Bimosiamose was safe and well tolerated. Dose compliance recorded by the employed Akita2 Apixneb nebulizer (Activaero) was high. On top of standard bronchodilator treatment, Bimosiamose showed a broad and favorable anti-inflammatory effect, reducing most of the evaluated sputum markers. In particular, Interleukin-8 (primary endpoint), a biomarker in COPD related to disease severity, was significantly reduced (p<0.009) in sputum of Bimosiamose treated patients at day 28, as compared to placebo. Notably, there was a trend on improvement of lung function following inhalation with Bimosiamose.
"This proof of concept study clearly demonstrates that inhaled Bimosiamose is attenuating inflammation in patients with COPD," said Prof Wolfgang Meyer-Sabellek, Chief Medical Officer of Revotar. "In addition, with trends in lung function improvement and a good safety profile these data encourage to proceed with clinical development translating the anti-inflammatory potential of Bimosiamose into significant long-term clinical benefit."
"This study is a major milestone on the way towards the establishment of pan-selectin antagonism as a novel therapeutic option in COPD", added Dr Martin Pöhlchen, CEO of Revotar. Detailed data will be submitted for publication in a peer-reviewed respiratory journal.
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-$.
Revotar develops innovative drugs for inflammatory indications such as chronic obstructive pulmonary disease (COPD), acute lung injury (ALI) and asthma. Its lead candidate Bimosiamose, a pan-selectin antagonist, has already passed several clinical phase I and phase IIa trials in COPD, asthma, and psoriasis with a good safety and efficacy profile in over 300 patients and volunteers. Furthermore Revotar has two preclinical programs addressing respiratory and other inflammatory diseases.