Clinical TrialJun 1, 2026, 08:02 AM
Aura Biosciences Completes Phase 3 CoMpass Trial Enrollment for Bel-sar
AI Summary
Aura Biosciences, Inc. announced the completion of enrollment for 108 patients in its registration-enabling Phase 3 CoMpass trial. This trial is evaluating belzupacap sarotalocan (bel-sar) as a frontline treatment for early choroidal melanoma. The company expects to report topline data for the 15-month primary endpoint in the second half of 2027, marking a significant step towards potential regulatory approval for this vision-preserving therapy.
Key Highlights
- Aura Biosciences completed enrollment of 108 patients in its Phase 3 CoMpass trial for belzupacap sarotalocan (bel-sar).
- Topline data for the 15-month primary endpoint are anticipated in the second half of 2027.
- Bel-sar is being evaluated as a frontline treatment for patients with early choroidal melanoma.
- The global, randomized Phase 3 trial is conducted under a Special Protocol Assessment (SPA) agreement with the FDA.
- Bel-sar has received Orphan Drug Designation from both the FDA and EMA, and Fast Track designation from the FDA.
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