NRx Pharmaceuticals Drug Candidate Shows Potent Antibacterial Activity Against Urinary Pathogens
NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) drug candidate, NRX-101, has demonstrated a potent antibacterial effect against antibiotic-resistant pathogens in in vitro models. NRX-101 (D-cycloserine + lurasidone) was tested against pathogens known to cause complicated urinary tract infections (cUTIs).
cUTI is increasingly common in the US, with an estimated 3 million new diagnoses annually. These infections are caused by antibiotic-resistant pathogens and are likely to cause sepsis, a lethal condition. Approximately 17,000 deaths per year in the United States are attributed to genitourinary sepsis.
NRX-101, a fixed dose combination of D-cycloserine and lurasidone, has been granted Fast Track Designation, Breakthrough Therapy Designation, a Special Protocol Agreement, and a Biomarker Letter of Support from the FDA for S-TRBD.
If successfully developed, NRX-101 could offer cUTI patients an effective therapy with a favorable safety profile.NRx has already completed the phase 3 manufacture of NRX-101 and is in a position to immediately seek investigational human use for 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’s lead program NRX-101, an oral, fixed-dose combination of D-cycloserine and lurasidone, targets the brain’s N-methyl-D-aspartate (NMDA) receptor and is being investigated in a Phase 2b/3 clinical trial for suicidal treatment-resistant bipolar depression (S-TRBD), which includes patients with both acute and sub-acute suicidality, an indication for which the only approved treatment is electroshock therapy. The Company has partnered with Alvogen Pharmaceuticals, who owns the worldwide rights to NRX-101 for treatment of S-TRBD, to help bring NRX-101 to a global population of patients with unmet medical need. NRx Pharmaceuticals is currently exploring NRX-101’s potential to act as a non-opioid chronic pain treatment option and is continuing to plan to enroll patients in an Israeli-based trial of patients suffering from post-traumatic stress disorder with depression and suicidality.