Date: 2011-03-04
Type of information:
phase: 2
Announcement: results
Company: Revotar (Germany)
Product: inhaled Bimosiamose
Action mechanism: pan-selectin antagonist
Disease: chronic obstructive pulmonary disease (COPD)
Therapeutic area: Respiratory diseases
Country: Germany
Trial details: In this 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.
Latest
news: 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 demonstrates that inhaled Bimosiamose is attenuating inflammation in patients with COPD. Detailed data will be submitted for publication in a peer-reviewed respiratory journal.
