Revotar Biopharmaceuticals
AG announced that a proof of concept, double-blind, cross-over, allergen
challenge study in mild allergic
asthmatics demonstrated first positive clinical
results of its pan-selectin antagonist bimosiamose. Pretreatment with nebulized bimosiamose
compared to placebo decreased the Late Asthmatic Response (LAR) in
patients following allergen challenge.
Bimosiamose met the protocol indicated primary endpoint of relative LAR decline vs. maximum FEV1 baseline values (p=0.05, Wilcoxon Signed Rank Test). This is the endpoint recommended by the
American Thoracic Society for
asthma studies of this type. The drug was also well tolerated.
"This is the first human trial using a selectin antagonist which demonstrates positive clinical results in
allergic asthma," stated Drs. Kai-Michael Beeh and Jutta Beier, who
conducted the study at Mainz University Hospital,
Germany. "Bimosiamose showed
excellent safety and tolerability in the treatment phase and may therefore evolve as
an alternative to the present use of
steroids."
"These results represent an important contribution in advancing the understanding of
the pathophysiology of asthma. The interruption of the transmigration of inflammatory
leukocytes into lung tissue by an
adhesion molecule blocker provides for a new
therapeutic strategy for this disease," said Dr. Rainer N. Zahlten, Chief Scientific Officer at Revotar. "In addition, this important trial validates for the first time human ad-hesion
molecules, such as E-, P- and L-Selectin, as new potential therapeutic targets in asthma," he added.
Following additional data analysis, the detailed results will be published and presented at upcoming international symposia.
Clinical Trial Design
Twelve steroid-naive male volunteers with a diagnosis of mild allergic asthma were enrolled in this double-blind, randomised, single center study, conducted according to
GCP-ICH guidelines, after they qualified through an allergen challenge control test
with a required late asthmatic response. Following 3-5 week wash-out intervals,
treatment periods over 3.5 days with bimosiamose or placebo inhalation, dosed twice
daily, were initiated prior to re-challenge with an allergen. Following another wash-out
period of 3-5 weeks, patients were crossed-over and subjected to the alternate treatment with either placebo or bimosiamose before another allergen challenge
commenced. Therefore, each patient served as their own control.