Update on Riquent program
San Diego-based La Jolla Pharmaceutical has provided an update on its clinical and regulatory activities concerning its drug candidate, Riquent (abetimus sodium), for lupus renal disease.
San Diego-based La Jolla Pharmaceutical has provided an update on its clinical and regulatory activities concerning its drug candidate, Riquent (abetimus sodium), for lupus renal disease.
In a clinical study of Riquent in lupus patients, the company is now recruiting patients at 29 of 60 planned US clinical trial sites in 28 States. Screening and enrollment of patients is proceeding as planned. The multi-dose study of the impact of Riquent on lupus kidney disease, a leading cause of morbidity and mortality in lupus patients, was initiated in August 2004 under a Special Protocol Assessment agreement with the Division of Cardio-Renal Drug Products of the FDA. The study is evaluating weekly doses of 100 mg and 300 mg of Riquent over a 12-month period in lupus patients with a history of renal disease.
As part of its Special Protocol Assessment agreement, La Jolla Pharmaceutical is also evaluating higher doses of Riquent for use in the multi-dose clinical study discussed above. In a study in healthy volunteers, one group received a single dose of either 600 mg of Riquent or placebo, and a second group received a single dose of either 1200 mg of Riquent or placebo. In each group, six volunteers received Riquent and two received placebo. Both doses of Riquent appeared to be well tolerated. Based on previous studies of Riquent, the company believes that certain lupus patients may benefit from higher doses of Riquent. Once the dosing study is completed, the company plans to review the data from the study with the FDA and then may choose to study additional doses.
Since receiving the approvable letter for Riquent on October 14, 2004, La Jolla has met twice with the FDA to discuss the approvable letter and data concerning Riquent.
The company has two additional meetings currently scheduled. There is no guarantee that these discussions will result in any modification of the approvable status of Riquent or the company's need for data from an additional study, such as data from the large multi-dose study discussed above, prior to any approval.
The company has met with the EMEA, which has designated two countries to lead the review of the company's European regulatory filing. Because of the efforts involved in its ongoing discussions with the FDA, the company anticipates a delay in filing its MAA for Riquent in Europe. In addition, while discussions with the FDA are ongoing, the company has taken steps to control certain costs associated with its research, development and other activities.