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RADNOR, Pa., April 8, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced that the Company has achieved data-lock in its Phase 2b/3 Suicidal Treatment Resistant Bipolar Depression Study with NRX-101. With data-lock, as forecast in last week's earnings call, the complete data set passed on for statistical analysis; top-line data release expected in April 2024.
With positive data from this study and FDA comment, NRx becomes eligible to receive the balance of its first milestone (an additional $4 million) from partners Alvogen, Inc. and Lotus Pharmaceuticals, Inc. (1745.TW). These partners would then be responsible for all future development costs in this indication. NRx retains rights for all other indications, including chronic pain and PTSD. NRx is then poised to receive $320 million in further milestones along with mid-teen royalties on Net Sales.
NRX-101 has been awarded Breakthrough Therapy Designation, Fast Track Designation, a Biomarker Letter of Support, and a Special Protocol Agreement by the FDA for treatment of Suicidal Treatment Resistant Bipolar Depression. It is the only oral medication to have demonstrated both reduced symptoms of depression and reduced suicidal ideation in patients with bipolar depression, a lethal disease that claims the lives of one in five who live with it.
The previous STABIL-B trial, (Ref. STABIL-B) resulted in the award of Breakthrough Therapy Designation for the use of NRX-101 following ketamine in hospitalized patients with Severe Bipolar Depression and Acute Suicidal Ideation and NRx was cleared by FDA to conduct a phase III trial in this regard under the Special Protocol Agreement. FDA then suggested that the Company explore whether NRX-101 might be applicable to the much larger population of patients with subacute suicidality who are cared for in the outpatient setting on a chronic basis. The purpose of this trial was to determine whether a signal could be detected that would support a much broader indication for NRX-101. Successful data in this regard would expand the potential market for NRX-101 from several hundred thousand patients per year to several million patients per year.
"Patients with active suicidal ideation have been excluded from the clinical trials of all previously known oral antidepressants. This trial of NRX-101 is the first under an FDA Investigational New Drug application to attempt to develop an oral therapy that offers patients with suicidal bipolar depression an alternative to electroconvulsive therapy, which is currently the only FDA-approved therapy for suicidal depression," said Dr. Jonathan Javitt, Founder, Chairman and Chief Scientist of NRx Pharmaceuticals. "The Company has also announced plans to submit a New Drug Application to FDA this quarter for the use of ketamine as a short-term therapy for suicidal bipolar depression. We believe this is the first trial to demonstrate that suicidal patients can safely be enrolled and treated within the context of a clinical trial, and this was only possible because of the close monitoring of our study investigators and site personnel. We are deeply appreciative of the tremendous work done by our clinical development team, the study sites and, most importantly, the patients who participated in our trial."
The Phase 2b/3 trial (www.clinicaltrials.gov NCT 03395392) is a randomized, prospective, multicenter, double-blind study comparing NRX-101 to lurasidone over six weeks. The Principal Investigator is Prof. Andrew Nierenberg of Harvard Massachusetts General Hospital. The primary efficacy endpoint is reduction in depression as measured on the Montgomery-Asberg Depression Rating Scale (MADRS) and the secondary endpoint is reduction of suicidal ideation as measured by the Clinical Global Impression Suicidality Scale (CGI-SS). As previously disclosed, treatment compliance and concordance of local raters to central raters scores was in excess of 94%, well above the industry standard that is normally seen in CNS trials.
Posted In: NRXP
