New York, December 19, 2023 – NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) has been granted FDA clearance for its Investigational New Drug Application (IND) for NRX-101 for the treatment of complicated Urinary Tract infections (cUTI). The company’s shares surged 25% in trading on Monday following the news.
Complicated Urinary Tract Infections afflict approximately 3 million Americans each year, and pathogens have become increasingly resistant to commonly used antibiotics. New treatment options are urgently needed,” said Jonathan Javitt, MD MPH, Founder and Chief Scientist of NRx. Pharmaceuticals.
NRx has requested Qualified Infectious Disease Product (QIDP) designation from the FDA and expects a response in early Q1 2024.
Highlights
NRx has appointed Michael Manyak, MD, as Lead Clinical Advisor for the development of NRX-101. Professor Manyak is an internationally-recognized urologist who trained at leading universities and the US National Institutes of Health.
Dr. Manyak said, “At a time when routine use of standard antibiotics demonstrates increasing resistance and failure to control urinary tract infections, I believe it is vital to advance safe, oral antibiotics for complicated UTI that have the potential to avoid the need for intravenous therapy, to keep patients out of the hospital, and to save lives. I look forward to learning whether the efficacy we demonstrated for NRX-101 in the laboratory against some of the most resistant bacteria can be replicated in patients.”
The manufacturing phase of NRX-101 is complete and the Company has secured Composition of Matter patent protection.
Today, NRx also announced that it has signed a License Data and Technical Information Agreement with Columbia University for rights to data from a randomized, active-controlled trial of 80 patients hospitalized for Acute Suicidality in Depression. This represents NRx’s second well-controlled trial demonstrating the efficacy of IV Ketamine in this indication.
About NRx Pharmaceuticals
NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain and PTSD. The Company is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. NRx has partnered with Alvogen Pharmaceuticals around the development and marketing of NRX-101 for the treatment of suicidal bipolar depression. NRX-101 additionally has potential to act as a non-opioid treatment for chronic pain.
NRx has recently announced plans to submit a New Drug Application for ketamine in the treatment of suicidal depression, based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and newly obtained data from French health authorities, licensed under a data sharing agreement. NRx was awarded Fast Track Designation for development of ketamine (NRX-100) by the US FDA as part of a protocol to treat patients with acute suicidality.
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