Aura Biosciences Gets FDA Agreement Regarding Phase 3 Clinical Trial of Bel-Sar

By Stephen Nakrosis

Aura Biosciences on Monday said it received agreement from the U.S. Food and Drug Administration for the design and plan of a Phase 3 trial of belzupacap sarotalocan as a treatment for patients with early-stage choroidal melanoma.

The company said it received the agreement from the FDA for the CoMpass phase 3 clinical trial of belzupacap sarotalocan, or Bel-sar, under a special protocol assessment.

If successful, Aura said, the trial could address the objectives necessary to support the company's planned biologics license application submission for Bel-sar as a treatment for choroidal melanoma, which is a form of eye cancer.

Aura said it presented "positive Phase 2 safety and efficacy data of Bel-sar" at the American Academy of Ophthalmology meeting in San Francisco.

Also on Monday, Aura said preliminary data from a phase 1 trial in bladder cancer showed the first patient using a single dose of Bel-sar with light activation demonstrated a clinical complete response "demonstrated by absence of cancer cells on histopathology with evidence of extensive necrosis and immune activation."

Write to Stephen Nakrosis at stephen.nakrosis@wsj.com

(END) Dow Jones Newswires

November 06, 2023 15:35 ET (20:35 GMT)

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