Thursday, Aura Biosciences, Inc. (NASDAQ:AURA) revealed Phase 2 end-of-study results evaluating bel-sar (AU-011) for the first-line treatment of early-stage choroidal melanoma (CM), a vision and ocular cancer.
The Phase 2 results demonstrated that bel-sar achieved an 80% tumor control rate (n=8/10) among Phase 3-eligible patients who received the therapeutic regimen, with complete cessation of growth following treatment among responders (post-treatment average growth rate of 0.011 mm/yr among responders compared to 0.351 mm/yr before study entry; p<0.0001).
Visual acuity preservation was achieved in 90% of these 10 patients. 80% of these 10 patients were at high risk for vision loss with tumors close to the fovea or optic disc.
The company adds that the current standard of care is radiotherapy, which leads to visual acuity of <20/200 (the cutoff for legal blindness) in the treated eye in up to 87% of patients.
The safety profile of bel-sar was highly favorable in all participants regardless of dose.
No treatment-related serious adverse events (SAEs) were reported. Ocular treatment-related AEs (TRAEs) were mild and resolved without sequelae.
Aura received a written agreement from the FDA under a Special Protocol Assessment (SPA) for the design and planned analysis of the global Phase 3 CoMpass trial. The agreement indicates that the FDA concurs with the study’s adequacy, if successful, to address the objectives necessary to support Aura’s planned biologics license application submission.
Price Action: Aura stock is up 6.39% at $9.65 at last check Thursday.
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