Revotar Biopharmaceuticals presents first positive clinical results with a small molecule selectin antagonist in allergic asthma

08-Aug-2003

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.

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