Aurinia Selects Worldwide As CRO For Phase3 Valcosporin Trial
Aurinia Pharmaceuticals Inc., a clinical stage biopharmaceutical company focused on the global immunology market, today announced that it has selected Worldwide Clinical Trials (“Worldwide”) as its Clinical Research Organization (CRO) for the AURORA Phase 3 study of volcosporin for the treatment of active lupus nephritis (LN).
“Selecting a CRO for AURORA is a key milestone for Aurinia following our successful end-of-Phase 2 meeting with the U.S. Food & Drug Administration (FDA) Division of Pulmonary, Allergy and Rheumatology Products. We are thrilled to partner with Worldwide to support the AURORA Phase 3 clinical trial,” said Charles Rowland, Chief Executive Officer of Aurinia. “We are rapidly moving forward with our plans to bring this important therapy to market for patients living with this devastating disease, and Worldwide’s deep expertise and capabilities in managing pivotal trials will be a tremendous asset to us. We are on track to commence the AURORA trial in the second quarter of 2017, and we expect the results from this study will support a New Drug Application (NDA) submission to the FDA.”
With support from Worldwide, Aurinia will proceed with conducting a randomized, placebo-controlled, double-blind global 52-week trial in approximately 320 patients. The primary endpoint as in the Phase 2b AURA trial is renal response (complete remission), at 24 weeks. In addition to the assessment of renal response, a key marker of clinical benefit in this population is the duration of proteinuria improvement. Therefore, secondary endpoints will include the duration of renal response at 52 weeks (48 weeks in AURA), an efficacy measure which delineates durability of renal response (remission), an important parameter in evaluating long-term outcomes for the treatment of LN.
“Our entire Worldwide team is delighted to have been selected as Aurinia’s CRO partner to advance voclosporin, which has the potential to become the first FDA-approved treatment for LN,” said Peter Benton, President and Chief Operating Officer at Worldwide Clinical Trials. “We’re truly honored that an innovator like Aurinia recognizes what Worldwide brings to the table: medical and scientific expertise, proactive insight, dogged determination, rigorous processes and a commitment to getting it right. We’re looking forward to working closely with Aurinia’s clinical development team on this new therapy, which could significantly improve the lives and long-term outcomes of patients suffering from LN.”
This article has been republished from materials provided by Aurinia. Note: material may have been edited for length and content. For further information, please contact the cited source.
Lissencephaly Modeled in a Dish for the First TimeNews
Researchers describe how cells from patients with the severe developmental disease lissencephaly differ from healthy cells. The method can provide vital new knowledge on difficult-to-study congenital diseases.READ MORE
Discovery Provides Hope for New Vaccine Against Flesh-eating BacteriaNews
Researchers at Houston Methodist have solved a 100-year-old mystery, providing them a possible key to unlock a pathway for treating diseases caused by flesh-eating bacteria.READ MORE