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news.Revotar Biopharmaceuticals has initiated 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).
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The trial is designed as a double-blind, placebo controlled, randomised, cross-over study comprising up to 60 non-smoking patients with moderate to severe COPD (GOLD II-III).
Revotar said that in the trial, each subject will receive nebulized Bimosiamose solution or vehicle for 28 consecutive days twice daily in two subsequent periods according to a randomisation 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.
Wolfgang Meyer-Sabellek, chief medical officer of Revotar, said: “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. We are now looking forward to confirm and extend this encouraging potential on the basis of longer treatment and more COPD outpatients.”
Martin Pohlchen, CEO of Revotar, said: “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.”