Alume Biosciences, Inc. says the first patient has been dosed in a phase 3 pivotal study of ALM-488, a peptide-dye conjugate designed to highlight nerves with fluorescence in real time during surgery.
“The successful initiation of this phase 3 pivotal study is another major milestone for Alume Biosciences. It marks the final phase of clinical trial testing for ALM-488 for patients undergoing Head and Neck Surgery,” said Brett Berman, chief medical officer at Alume Biosciences.
“This study underscores our commitment to improve intraoperative visualization of nerves, enabling Precision Surgery.”
Alume Biosciences successfully completed the phase 1/2 studies of ALM-488 in patients undergoing head and neck surgery in 2021. Phase 3 studies are being conducted at multiple academic medical centers throughout the U.S., and they are projected to be completed in 2023.
“We look forward to exploring the power of ALM-488 as an intraoperative tool to identify nerves and potentially improve outcomes for our patients,” said Karthik Rajasekaran, principal investigator at the University of Pennsylvania.
ALM-488 is a fluorescent peptide-dye conjugate in the visible spectrum and can be visualized with fluorescently enabled instrumentation including filter modified loupe systems, portable handheld systems, microscopes and laparoscopes.
ALM-488 binds to the extracellular matrix of nerves, allowing real-time nerve illumination during surgery. ALM-488 is expected to have broad surgical application due to unique characteristics of binding that are independent of myelin.
This allows ALM-488 to highlight multiple types of nerves including motor, sensory, and autonomic. Degenerated nerves, critically important during reconstructive procedures, are also highlighted with ALM-488.
Surgeries where nerves are potentially at risk include procedures in the skull base, head and neck, spine, and nerve sparing prostatectomy. In vivo studies also indicate ALM-488 has adequate pharmacokinetic characteristics to support clinical utility for the labeling of ureters in urology, gynecology and lower abdominal surgical indications.
About Alume Biosciences
Alume Biosciences is a late-stage clinical biotechnology company developing nerve specific targeting molecules. In addition to ALM-488, Alume is developing other nerve specific agents for diagnostic and therapeutic indications.
The company was founded in 2017 and is headquartered in the Johnson & Johnson Innovation incubator JLABS @ San Diego.