RADNOR, PA — NRx Pharmaceuticals, Inc. (Nasdaq: NRXP), a clinical-stage pharmaceutical company, has announced the clearance of its Investigational New Drug Application (IND) by the US Food and Drug Administration (FDA). The IND pertains to NRX-101, a patented combination of D-cycloserine and lurasidone, proposed for the treatment of complicated Urinary Tract Infections (cUTIs).
An estimated 3 million Americans annually grapple with cUTIs, a condition increasingly difficult to treat due to growing antibiotic resistance. “New treatment options are urgently needed,” said Jonathan Javitt, MD MPH, Founder and Chief Scientist of NRx Pharmaceuticals. The unique formulation of NRX-101 combines D-cycloserine, an antibiotic excreted unmetabolized in the urine and known to the World Health Organization as an anti-tuberculosis agent, with small amounts of lurasidone. This combination is designed to counter the central nervous system side effects of D-cycloserine, potentially making NRX-101 a significant new patented antibiotic.
In a strategic move, NRx plans to spin off this program into an independent company focused on further development and commercialization of NRX-101 for cUTIs. Given that the manufacturing phase of NRX-101 is complete, and commercial-grade drug product is already available, this initiative is not expected to require additional investment in research and development prior to clinical trials.
This plan mirrors the company’s earlier strategy for Hope Therapeutics, which was spun out to develop NRX-100 (IV Ketamine) for suicidal depression. The new spin-off will be owned by NRx, existing shareholders via a share dividend, and new investors.
Prof. Michael Manyak, MD, an internationally-recognized urologist, has been appointed as Lead Clinical Advisor for this initiative. With a wealth of experience, including his recent roles as Global Medical Affairs Director for the GlaxoSmithKline urology franchise and Chief Medical Advisor for Crisis Response for Accenture, his expertise will be invaluable in guiding the clinical development of NRX-101.
Investors will be keeping a close eye on the company’s progress, as it awaits the FDA’s response to its request for Qualified Infectious Disease Product (QIDP) designation, expected next month. The clearance of the IND and the potential spin-off announcement mark significant milestones for NRx and could herald a new era in the treatment of cUTIs.
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