Noema Pharma, a clinical-stage biotech company targeting debilitating central nervous system (CNS) indications, today announces that the US Food and Drug Administration (FDA) has granted Fast Track designation to its mGluR5 inhibitor basimglurant (NOE-101) for the treatment of trigeminal neuralgia (TN).
Fast Track designation aims at facilitating the development and expediting the review of drugs to treat serious conditions with clearly defined unmet medical needs, with the purpose to bring important new drugs to patients earlier.
George Garibaldi MD, President, Head of R&D of Noema Pharma.
“We are very pleased to receive Fast Track designation from the FDA, which is intended to bring promising medicines to patients sooner, and very much underlines the potential of basimglurant in pain management associated with TN,”
He added, “The designation means we will be working closely with the FDA’s Division of Anesthesia, Addiction Medicine, and Pain Medicine, which regulates Investigational New Drug applications and marketing applications of drugs for the treatment of pain. We look forward to increasing our collaboration with regulators and receiving feedback on the next steps for our clinical program in TN.”
Dr. Raymond Sekula, Professor of Neurological Surgery at the Columbia University Irving Medical Center and Principal Investigator of the LibraTN study.
“TN is a chronic condition that affects the trigeminal nerve carrying sensations from the face to the brain, which can cause excruciating pain in those who suffer from it. Four to five of every 100,000 people in the US are affected by TN every year. The most common of the very limited treatment options available is an anticonvulsant first approved over 50 years ago and associated with several limitations. It is critical that new therapeutic options be developed for this condition. Basimglurant is an exciting new product candidate with potential to help people afflicted with TN.”
The FDA authorized Noema Pharma’s Investigational New Drug (IND) application to initiate a Phase 2/3 clinical trial of basimglurant in TN in February 2022. The LibraTN trial (NCT05217628) is a multi-center, 24-week, prospective, double-blind, randomized-withdrawal, placebo-controlled study to evaluate the efficacy and safety of NOE-101 in adults with pain associated with TN. The study is currently ongoing in multiple countries. Basimglurant is a highly selective, potent, and cell-penetrant negative allosteric modulator of metabotropic glutamate receptor 5 (mGluR5). It has previously been found to be safe and well tolerated in adult subjects and was effective in controlling pain in multiple animal models of neuropathic pain.
Noema Pharma has positioned Trigeminal Neuralgia at the core of its therapeutic focus and is pioneering the development of a comprehensive therapeutic toolkit to help patients affected with this condition. This includes developing basimglurant through clinical trials as well as developing the Trigeminal Neuralgia Electronic Diary (TNED), a state-of-the-art research tool designed to be used in TN clinical trials and in outpatient settings to help patients communicate with their health care provider about their disease and physicians to optimize treatments.