Gevokizumab appeared to be well tolerated in the trial, and incidence of adverse events was comparable between both active groups and placebo. The study was dosed in a mg/kg fashion with mean patient weights of approximately 74 kg, thus actively treated patients received mean absolute doses at the 0.2mg/kg and the 0.6mg/kg of around 15 mg and 45 mg respectively.
"The preliminary results of this initial proof-of-concept trial are encouraging as we demonstrated clear activity according to the IGA parameter, and we also established a no-effect dose. The data from our analysis of inflammatory lesion count demonstrate statistical significance at the 0.6mg/kg dose for the Day 42 measurement. I believe the safety profile and preliminary activity results seen with gevokizumab clearly warrant further evaluation in moderate to severe inflammatory acne, including with higher doses we are using in our other studies. The study also provided key information on placebo response rates in this specific acne population, and this knowledge will be useful in the design of future trials," offered Paul Rubin, M.D., Senior Vice President of Research and Development and Chief Medical Officer of XOMA.
"We designed XOMA's Phase 2 proof-of-concept program to expand our understanding of the potential for gevokizumab to treat several different diseases characterized by IL-1 beta over-expression. We are encouraged by these preliminary top-line results, which demonstrate gevokizumab's potential to treat inflammatory lesions and affect the physicians overall assessment associated with moderate to severe acne vulgaris," commented John Varian, Chief Executive Officer of XOMA. "We await the complete data from this trial and the results from our Phase 2 POC studies in erosive osteoarthritis of the hand and non-infectious scleritis, which are expected later this year. At that time, we and our partner, Servier, expect to be able to determine our next indication to follow non-infectious uveitis into Phase 3 development."
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