Revotar Announces First Positive Results With a New Topical Formulation of a Small Molecule Selectin Antagonist in Psoriasis
Revotar Biopharmaceuticals AG announced today that a phase IIa, double-blind, randomized, placebo controlled clinical trial in psoriatic patients demonstrated antipsoriatic efficacy of a topical formulation of bimosiamose (bimosiamose microemulsion), i.e. significant decline of infiltrate thickness. In this phase IIa exploratory trial, a new topical formulation of the small molecule selectin antagonist bimosiamose has been investigated. Analyzed parameters of the employed psoriatic plaque test were erythema intensity (mean redness) measured by chromametry and infiltrate thickness of the plaque as measured by sonography. Mean redness values remained nearly constant over time for bimosiamose microemulsion and its corresponding vehicle. Thickness of the plaque infiltrate did not change after 10 days of treatment in the vehicle group. In contrast, bimosiamose microemulsion treated plaques demonstrated a significant decline in infiltrate thickness after 10 days of treatment as compared to its corresponding vehicle (-10.5%, p=0.019) and as compared to its own baseline (-13%, p=0.0007). Together with the previous positive results in a pilot open-labelled clinical trial in patients with moderate to severe psoriasis where clinical and laboratory improvements could be demonstrated after intradermal administration of bimosiamose, the results of both trials suggest bimosiamose as a promising drug candidate for psoriasis by both injectible and topical route of administration said Gerhard Wolff, Director of Preclinical and Clinical Development, Revotar Biopharmaceuticals AG. These confirmatory results give Revotar Biopharmaceuticals AG the confidence to take the clinical development to the next level.
About Psoriasis, Selectins and Bimosiamose
Psoriasis is a chronic inflammatory skin disorder characterized by scaling erythematous patches and plaques of skin. The estimated prevalence of psoriasis ranges from 0.5% to 4.6% worldwide. For example, in the United States, 5-7 million individuals are estimated suffering from psoriasis. Alternative new therapies are highly desirable compared to some of the recently approved biotechnology-based therapies. Bimosiamose is a pan-selectin antagonist, targeted against the selectin family of vascular cell adhesion molecules which is comprised of three structurally related calcium-dependent carbohydrate binding proteins, E-, P- and L-selectin. Because all three selectins are known to support the inflammatory process of various diseases, scientists at Revotar Biopharmaceuticals AG believe that inhibition of all three selectins by bimosiamose may be advantageous in blocking the inflammatory process in psoriasis.
About the Clinical Trial Design
The phase IIa, double-blind, randomized, placebo controlled clinical trial investigated according to the GCP-ICH guidelines the antipsoriatic efficacy of bimosiamose microemulsion (1%) in a psoriatic plaque test (PTT), compared to the corresponding active ingredient-free vehicle. Twelve patients, were enrolled and completed the 12 day study period during they received ten occlusive treatments with the study preparation, vehicle, comparators and negative control.
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