La Jolla Pharmaceutical Corporation of San Diego, California, announced that it has entered into an agreement for the sale of common stock and warrants valued at $66 million to begin re-enrollment and expansion of its phase III clinical benefit trial for abetimus sodium (Riquent®), an immunomodulating agent for the treatment of lupus renal disease.
Subject to the closing of the financing and the completion by La Jolla of a revised clinical trial protocol under a Special Protocol Assessment (SPA) and its final review by the US Food and Drug Administration (FDA), the company expects to initiate patient enrollment in the US in early 2006, to expand the phase III trial to Europe and Asia, and to file a Medical Marketing Authorization (MAA) application in Europe in the first quarter of 2006.
In October 2004, following a review of the company's New Drug Application (NDA) for abetimus sodium, the FDA issued an "approvable" letter, predicated on the successful completion of a clinical benefit trial. The analysis of the clinical data from the initial phase III trial of abetimus sodium (100 mg/week) showed that neither the primary endpoint—time to renal flare—nor the secondary endpoint—time to treatment with high-dose corticosteroids or cyclophosphamide—reached statistical significance.
In the current phase III clinical benefit study, La Jolla has refined the primary endpoint, added two higher dose groups (300 mg and 900 mg abetimus sodium/week), approximately doubled the number of patients for enrollment, restricted the use of immunosuppressive agents, and reduced the patient evaluation period to a fixed 12-month on-treatment. The company estimates it will take approximately 1 year to complete enrollment, and another year for completion of the study.
—A. Techman