Illuminare-1, A Novel Nerve Visualization Investigational Fluorophore, Granted Fast Track Designation by U.S. FDA

NEW YORK, May 25, 2021 /PRNewswire/ -- Illuminare Biotechnologies, a clinical-stage biotechnology company, announced that its novel nerve imaging agent, Illuminare-1, has been granted Fast Track Designation by the US Food and Drug Administration (FDA). Illuminare-1 is a small molecule, myelin binding agent, the company is developing as a surgical adjunct to improve the visualization and delineation of critical nerve structures intra-operatively. The ability to locate and delineate nerves in real time during surgical procedures may avoid serious, and potentially permanent, unintended nerve injury. The first human clinical trial of Illuminare-1 is scheduled to begin in 2Q 2021 at Memorial Sloan Kettering Cancer Center (MSK) in patients undergoing robot-assisted radical prostatectomy.

The FDA's Fast Track designation is intended to facilitate and expedite the development and review of new drugs which address high unmet medical needs in the treatment of serious or life-threatening conditions. The stated purpose of the designation is "to get important new drugs to the patient earlier". The Fast Track designation for Illuminare-1 will allow MSK and its collaborator, Illuminare Biotechnologies, to have more frequent interactions with the FDA throughout the development of Illuminare-1, potentially shortening time to approval and availability for patients.

"This is another important milestone for this novel agent and one which we hope will accelerate bringing it to our surgical patients," said Timothy Donahue, MD, lead trial investigator and Urologic Surgeon at MSK. "The Fast Track designation by the FDA highlights the unmet need for an agent with the potential to reduce unintended iatrogenic nerve injuries across an array of surgical procedures."

Surgery plays a prominent role as first line treatment across many medical conditions. The ultimate goal of surgery is to repair or remove damaged and/or diseased tissue while preserving vital structures, including nerves. Even with advanced surgical techniques, unintended nerve injury remains a leading cause of morbidity across many common surgical procedures. Complications of nerve injuries are often permanent and may result in loss of function, sensation, muscle atrophy, pain, chronic neuropathy, reduced quality of life, disability, and paralysis.

A detailed description of FDA Fast Track designation and other expedited programs may be found at the FDA website at https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track

About Illuminare-1

Illuminare-1 is a single dose injectable myelin binding fluorescent agent currently in development by Illuminare Biotechnologies, in collaboration with Memorial Sloan Kettering Cancer Center, to provide real time visualization and delineation of nerves as small as ~60 micron during both open and minimally invasive surgery under blue light illumination. Ideal for surgical applications, the agent is predicted to have a rapid onset of action and a duration of activity between 4-5 hours.

About Illuminare Biotechnologies

Illuminare Biotechnologies is a privately held clinical-stage biotechnology company founded in 2016 to develop Illuminare-1. For more information about the Company, please visit www.illuminarebio.com.

Memorial Sloan Kettering (MSK) has institutional financial interests related to the research noted in this release in the form of intellectual property rights and associated interests by virtue of licensing agreements between MSK and Illuminare.

SOURCE Illuminare Biotechnologies, Inc.