Alume Biosciences Granted FDA Fast Track Designation Of ALM-488 For Surgical Nerve Visualization


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

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