Revotar Biopharmaceuticals meets primary endpoint in Phase II COPD Study with inhaled Bimosiamose

09-Mar-2011 - Germany

Revotar Biopharmaceuticals AG 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."

https://www.bionity.com/en/news/131212/revotar-biopharmaceuticals-meets-primary-endpoint-in-phase-ii-copd-study-with-inhaled-bimosiamose.html