San Diego-based Alume Biosciences received US FDA Breakthrough Therapy Designation for bevonescein (ALM-488), an investigational fluorescent peptide-dye conjugate designed to enable real-time visualization of nerves during head and neck surgery in adults. The designation follows Fast Track Designation granted for the same indication in 2022.
Administered intravenously before surgery, bevonescein binds to peripheral nerve tissue and emits fluorescence in the visible spectrum, allowing surgeons to see highlighted nerves directly without a camera, imaging interface, or display monitor.
A Phase I Nature Communications publication in July 2025 reported results from 27 adults and established 500 mg intravenously as the optimal dose. At that dose, bevonescein significantly increased nerve signal-to-background ratio compared with white light alone, while no dose-limiting toxicities were reported.
Alume has since completed three multicenter, randomized Phase III trials spanning thyroid, parathyroid, parotid, and neck dissection procedures. Bevonescein significantly improved Nerve Conspicuity in all three studies, while pooled analyses also showed improvements in visible nerve length and branching delineation, each with p≤0.0001. Earlier topline results indicated that two studies met both co-primary endpoints, while the third met one co-primary endpoint. No serious drug-related adverse events were reported across the Phase III program.