- Aura Biosciences Inc AURA announced the presentation of interim Phase 2 safety and efficacy data of belzupacap sarotalocan (bel-sar; AU-011) with 9-10 months of follow-up.
- The trial evaluates two clinical endpoints: tumor control and visual acuity preservation using the suprachoroidal (SC) route of administration for early-stage choroidal melanoma (indeterminate lesions and small choroidal melanoma (IL/CM)).
- The results showed a statistically significant reduction in the tumor growth rate (-0.289 mm/yr, p = <0.0001) compared to each patient's documented growth rate at study entry and a 100% (8/8) tumor control rate.
- Related: Aura Biosciences Details Interim Data From Mid-Stage Study Of Ocular Oncology Drug.
- In addition, the visual acuity preservation rate was 88% (7/8), with most patients at risk for vision loss with tumors close to the fovea or optic disk.
- The overall tolerability profile of bel-sar was generally favorable, with no dose-limiting toxicities, treatment-related SAEs, or significant AEs reported.
- There was no posterior inflammation and only mild anterior inflammation (Grade 1) in 20% of the patients. Treatment-related AEs were predominantly mild and resolved without sequalae.
- Price Action: AURA shares are down 2.42% at $10.88 on the last check Thursday.
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