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.
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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 About Alume Biosciences Media Contact:
SOURCE Alume Biosciences |
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