“After evaluating the results of our earlier phase II clinical trial in 253 patients and after conducting additional laboratory work, we concluded that a reformulation of our original gel was needed to increase its skin penetration and improve other characteristics,” said John Castello, chairman of the board, president and CEO.
“We have conducted additional testing on research formulations of XOMA 629 and are happy to report that we have developed a reformulation that meets our criteria for skin penetration and anti-microbial activity.”
XOMA is currently conducting preclinical studies to optimize the reformulated product, with the goal of amending its Investigational New Drug application and initiating phase I clinical trials in 2007.
“While we will have to start at phase I with our reformulated product, the path to approval of topical preparations in acne is well established and our experience in this indication should allow us to expedite development significantly,” remarked Mr Castello.
According to the American Academy of Dermatology, acne affects nearly 100% of adolescents and nearly half of adults over 25 in the US.