Aura Biosciences (NASDAQ:AURA) has announced positive Phase 2 end-of-study (EOS) results evaluating the safety, tolerability, and efficacy of bel-sar (AU-011) for the first-line treatment of early-stage choroidal melanoma (CM), a life-threatening ocular cancer.
The results demonstrated an 80% tumor control rate and 90% visual acuity preservation, with a highly favorable safety profile and no dose-limiting toxicities.
“We believe these Phase 2 results provide clinical evidence for bel-sar as a potential vision-sparing, first-line treatment option for patients with early-stage CM,” said Dr. Jill Hopkins, CMO and president of research and development at Aura. “Bel-sar is potentially a first-in-class novel therapy and we are excited to continue to advance this program, which is currently enrolling patients in our ongoing global Phase 3 CoMpass trial.”
Under a Special Protocol Assessment, Aura has received written agreement from the FDA for the design and planned analysis of the global Phase 3 CoMpass trial, which, the company points out, indicates concurrence by the FDA with the adequacy of the study, if successful, to address the objectives necessary to support Aura’s planned biologics license application submission.
