Revotar Biopharmaceuticals meets primary endpoint in Phase II COPD Study with inhaled Bimosiamose
Revotar Biopharmaceuticals AG /
Revotar Biopharmaceuticals meets primary endpoint in Phase II COPD Study with
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BERLIN/Hennigsdorf (Germany), March 04, 2011 - 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 Akita(2) 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
PÃ¶hlchen, 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-$.
About Revotar Biopharmaceutical AG
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.
Dr Martin PÃ¶hlchen, CEO
Revotar Biopharmaceuticals AG
D-16761 Hennigsdorf / Germany
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Revotar Biopharmaceuticals AG
Neuendorfstr. 24a Hennigsdorf Germany
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