The Phase I study was designed as a single-center, open-label study comprising 6 male patients aged 18 years or older, with plaque type psoriasis, a Psoriasis Area and Severity Index (PASI) score of 5-15, and a Physician’s Global Assessment (PGA) of moderate or less. In order to evaluate the safety of a new topical formulation of the pan-selectin antagonist Bimosiamose, twenty percent of the body surface area, including all sites affected by plaque type psoriasis (at least 10%) and normal skin as required to reach 20%, were treated twice daily in the morning and evening for five days and once in the morning on study day six with Bimosiamose 5% Cream. Vital signs, safety laboratory parameters (hematology, clinical chemistry, serology at screening and urinalysis) as well as plasma concentrations of Bimosiamose were investigated.
"There were no adverse events in this study”, said Dr Wolfgang Meyer-Sabellek, Chief Medical Officer of Revotar, previously Senior Vice President Research & Development at AstraZeneca. “No clinically significant abnormal laboratory findings were noted and physical examination did not show relevant findings in any of the subjects. There was no or only very limited systemic exposure to Bimosiamose detectable which is in line with previous clinical and preclinical studies.” Already, Bimosiamose has been tested successfully in various indications (psoriasis, asthma and chronic-obstructive pulmonary disease COPD) in Phase I and Phase IIa trials.
“The results of this Phase I clinical study demonstrate safety of a topical treatment of Bimosiamose 5% Cream in patients with plaque psoriasis. The next step will be a Phase II proof of principle study in psoriasis”, added Dr Martin Pöhlchen, CEO of Revotar.
Revotar will present itself during the BioPartnering conference in London on October 13-14, 2008. About Revotar Biopharmaceuticals AG
Revotar develops innovative drugs for inflammatory indications such as psoriasis, asthma, chronic obstructive pulmonary disease (COPD) and acute lung injury (ALI). Its lead candidate Bimosiamose, a pan-selectin antagonist, has already passed several clinical phase I and phase IIa trials in asthma, COPD and psoriasis with a good safety and efficacy profile in nearly 200 patients and volunteers. In summer 2006, Revotar announced a Start-Up Development Agreement with a US Pharma company for the further development of Bimosiamose in one major disease area. In September 2008, Revotar announced the successful first closing of its Series A financing round of 5.3 million EUR, with an additional commitment of 3 million EUR based on certain preconditions to be met.
