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.
XOMA Announces Encouraging Interim Results From Gevokizumab Phase 2 Study For Moderate To Severe Acne Vulgaris
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