Sign in Subscribe
Pharmaceutical industry

La Jolla Pharmaceutical Reports Latest Developments on Riquent for Lupus Renal Disease Treatment

Strategic Insights

— 2 min read

La Jolla Pharmaceutical Company has made significant updates on its drug candidate, Riquent (abetimus sodium), for the treatment of lupus renal disease. The company has reactivated enrollment in its phase 3 trial, aiming to enroll approximately 600 patients from over 100 clinical sites in more than 10 countries. This international study will be the largest clinical trial ever conducted in lupus patients with a history of renal disease. Riquent has shown promise in reducing levels of antibodies to double-stranded DNA (dsDNA), which are believed to cause lupus renal disease.

Key Takeaways:

  • La Jolla Pharmaceutical Company has reactivated enrollment in its phase 3 trial of Riquent (abetimus sodium) for the treatment of lupus renal disease, with a goal to enroll approximately 600 patients from over 100 clinical sites in more than 10 countries.
  • The trial will be a double-blind, placebo-controlled, randomized study designed to gain FDA approval for Riquent as a treatment for lupus renal disease, with a primary endpoint of time to renal flare.
  • The trial protocol has been finalized under a special protocol assessment (SPA) with the FDA, including several modifications to improve the probability of demonstrating the clinical benefit of Riquent.
  • Approximately 80% of Riquent-treated patients will receive a higher dose than the previous phase 3 trial, with 40% receiving 300 mg per week, 40% receiving 900 mg per week, and 20% receiving 100 mg per week.
  • The study will evaluate treatment for 12 months, compared to the previous phase 3 trial, which treated patients for up to 22 months.
  • Riquent has shown promise in reducing levels of antibodies to dsDNA, which are believed to cause lupus renal disease, and a larger number of patients in this trial should increase the likelihood of seeing a statistically significant difference between the Riquent-treated group and the placebo-treated group.
  • The trial will involve a greater number of nephrology clinics, which should allow the study to enroll more patients with impaired renal function, the specific group that showed increased benefit from Riquent treatment.
  • Riquent is the first drug candidate specifically developed for the treatment of lupus renal disease, a leading cause of sickness and death in lupus patients, with a 10-year history of over 800 patients and subjects in 13 clinical trials.

Statistics:

  • The phase 3 trial will enroll approximately 600 patients from over 100 clinical sites in more than 10 countries.
  • 80% of Riquent-treated patients will receive a higher dose than the previous phase 3 trial.
  • 40% of Riquent-treated patients will receive 300 mg per week, 40% will receive 900 mg per week, and 20% will receive 100 mg per week.
  • The study will evaluate treatment for 12 months, compared to the previous phase 3 trial, which treated patients for up to 22 months.
  • Riquent has been evaluated in 13 clinical trials over a 10-year time span that included over 800 patients and subjects.

Sources:

  • La Jolla Pharmaceutical Co. (LJPC) announced that it has reactivated enrollment in its phase 3 trial of Riquent (abetimus sodium) for the treatment of lupus renal disease.
  • Deirdre Y. Gillespie, MD, president and CEO of La Jolla Pharmaceutical Company stated that the global phase 3 study will be the largest clinical trial ever conducted in lupus patients with a history of renal disease.
  • Report by Science Letter editors from staff and other reports, Copyright 2006, Science Letter via NewsRx.com.

Read more