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Aura Biosciences Reports First Quarter 2023 Financial Results and Provides Clinical Development and Operational Highlights
U.S. Food and Drug Administration (FDA) Guidance in Type C Meeting Supports Global Phase 3 Trial in Early-stage Choroidal Melanoma Enrollment Complete in
About this update from Aura Biosciences, Inc.
[{"type":"text","content":"\nU.S. Food and Drug Administration (FDA) Guidance in Type C Meeting Supports Global Phase 3 Trial in Early-stage Choroidal Melanoma\n\n\nEnrollment Complete in Phase 2 Trial in Choroidal Melanoma Using Suprachoroidal Route of Administration\n\n\n BOSTON--(BUSINESS WIRE)--\nAura Biosciences Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, today reported financial results for the first quarter ended March 31, 2023, and provided clinical development and operational highlights.\n\n\n“We are encouraged by our recent interactions with the FDA in support of our global Phase 3 trial designed to enable us to develop the first vision preserving targeted therapy for the treatment of patients with early-stage choroidal melanoma, a disease with a high unmet medical need and no approved therapies,” said Elisabet de los Pinos, Ph.D., Chief Executive Officer of Aura. “With a strong balance sheet, we are well-positioned to execute and advance our pipeline to meaningful clinical milestones.”\n\n\nRecent Pipeline Developments\n\n\n\nAura is planning to initiate a potentially registration-enabling Phase 3 clinical trial in 1H 2023 to evaluate the safety and efficacy of Belzupacap Sarotalocan (bel-sar) for the first-line treatment of adult patients with early-stage choroidal melanoma (CM), a life-threatening rare disease with no approved therapies.\n\n\n\n\nThe Phase 3 clinical trial design incorporates guidance and feedback from the FDA following a recent Type C meeting.\n\n\n\n\nThe FDA recommended that the Phase 3 trial follow a standard three-arm randomized, controlled and masked design. The trial is intended to enroll approximately 100 patients and it will be randomized 2:1:2 to receive investigational therapeutic regimen bel-sar, low dose regimen bel-sar or a sham control. The primary efficacy analysis is planned to be a time to event composite endpoint that will compare the tumor control and visual acuity of the therapeutic regimen group to sham when the last patient meets 12 months of follow up.\n\n\n\n\nEnrollment is complete in the Phase 2 trial evaluating suprachoroidal (SC) administration of bel-sar for the first-line treatment of adult patients with early-stage CM. Updated interim data of patients treated with the therape...