San Diego, USA-based La Jolla Pharmaceutical says that it has recommenced enrollment in a Phase III trial of its developmental lupus treatment Riquent (abetimus sodium). The current study follows the Food and Drug Administrations's review of the product, which found that it was approvable pending the completion of an additional Phase III study demonstrating treatment benefit. The design of the trial was finalized by the firm and the FDA under a Special Protocol Assessment that includes several modifications designed to best demonstrate the compound's efficacy. Deidre Gillespie, president of the company, said, regarding the study "of primary importance is the fact that we have worked with the US FDA and outside experts to optimize the design." She added that the firm expected to complete enrollment in the second half of 2007.
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