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ALM-488 is a peptide-dye conjugate designed to fluorescently highlight nerves in real time during surgery LA JOLLA, Calif., Aug. 23, 2022 /PRNewswire/ -- Alume Biosciences, Inc, a leader in the field of nerve-targeted diagnostics and therapeutics, today announced that the first patient has been dosed in a Phase 3 pivotal study of ALM-488 (NCT05377554). ALM-488 is a peptide-dye conjugate designed to highlight nerves with fluorescence in real time during surgery. Continue Reading Alume Announces First Patient Dosed in Phase 3 Pivotal Study for Intraoperative Nerve Fluorescence. Tweet this Alume Biosciences Announces First Patient Dosed with ALM-488 in Phase 3 Pivotal Study in Patients Undergoing Head and Neck Surgery. "The successful initiation of this Phase 3 pivotal study is another major milestone for Alume. It marks the final phase of clinical trial testing for ALM-488 for patients undergoing Head and Neck Surgery" said Brett Berman, MD, chief medical officer at Alume Biosciences. "This study underscores our commitment to improve intraoperative visualization of nerves, enabling Precision Surgery™". Alume successfully completed Phase 1/2 studies of ALM-488 in patients undergoing Head and Neck Surgery in 2021. The Phase 3 studies are being conducted at multiple academic medical centers throughout the US, 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 MD, principal investigator at University of Pennsylvania. About ALM-488 ALM-488 is a proprietary 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 that ALM-488 has adequate pharmacokinetic characteristics to support clinical utility for the labelling 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. Learn more about Alume Biosciences at Media contact: [email protected] SOURCE Alume Biosciences

LA JOLLA, Calif., May 12, 2021 /PRNewswire/ -- Alume Biosciences, Inc., a clinical stage biotechnology company developing nerve-targeted pharmaceuticals for surgical and therapeutic use, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its lead compound ALM-488. ALM-488 is an investigational fluorescently labelled nerve targeting pharmaceutical being developed as an adjunct for the visualization of nerves at risk for injury during head and neck surgery. The Fast Track designation was approved by the FDA Division of Medical Imaging and Radiation Medicine (DMIRM), which is responsible for drug products used in the image-based diagnosis and monitoring of diseases. Fast Track Designation Highlights the Urgent Need for Improved Intraoperative Nerve Visualization Inadvertent nerve injury during surgical procedures can cause significant morbidity including numbness, paralysis, urinary incontinence and erectile dysfunction, depending on the clinical setting. "We are developing the GPS equivalent for intraoperative nerve visualization. ALM-488 has the potential to deliver significant benefit to patients undergoing surgery where nerves are at risk by fluorescently improving nerve contrast in real time," commented Quyen Nguyen, MD/PhD, Professor of Surgery at UCSD and CEO of Alume Biosciences. "Fast Track designation is an important milestone for Alume and we look forward to working closely with FDA to develop the next phase of our program." Fast Track designation is intended to facilitate the development and review of drugs used to treat serious conditions and to fill an unmet medical need. Fast Track designation enables Alume to have more frequent interactions with the FDA throughout its drug development process, so that an approved product can reach the market expeditiously. The Fast Track designation was granted based on preliminary data from Alume's ongoing Phase 1/2 clinical trial of ALM-488 in patients undergoing head and neck surgery. The study is currently active at three sites including the University California San Diego (UCSD), Stanford Medical Center and Harvard-Massachusetts Eye & Ear. Alume anticipates trial completion in Q2 2021. About ALM-488 ALM-488 is a proprietary fluorescent peptide-dye conjugate in the visible spectrum. 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, autonomic and degenerated nerves important during reconstructive procedures. 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 that ALM-488 has adequate pharmacokinetic characteristics to support clinical utility for the labelling of ureters in urology, gynecology and lower abdominal surgical indications. About Alume Biosciences Alume Biosciences is a clinical stage biotechnology company developing nerve specific targeting molecules for intraoperative imaging. 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. Learn more about Alume Biosciences at Media Contact: Dan Harvey dan.harvey@alumebiosciences.com