NRx Awaits Topline Data in Suicidal Bipolar Depression Treatment Trial
NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) has reached the ‘Last Patient, Last Visit’ milestone in its Phase 2b/3 Trial of NRX-101 in suicidal treatment resistant bipolar depression. The company announced that the 74th and last evaluable patient has completed their day 42 visit. Topline data is expected by the end of the quarter. NRx’s share price was up nearly 20% by the closing bell on Monday following the news.
Positive data from this trial triggers a $4 million milestone payment from Alvogen, a privately owned US-based company focused on developing, in-licensing, manufacturing and marketing pharmaceutical products. Alvogen will be responsible for future development and commercialization costs for this program. NRx’s agreement with Alvogen provides for up to $329 million in milestone payments and a royalty on net sales in the mid-teens.
Dr. Jonathan Javitt, Founder, Chairman and Chief Scientist of NRx Pharmaceuticals, commented, “This is the first clinical trial, to the company’s knowledge, conducted among patients with suicidal bipolar depression in the outpatient setting. Our previous trial measured the ability of NRX-101 to maintain the anti-depressant and anti-suicidal effect of ketamine administered in the hospital setting. These patients, whose clinical need is urgent and extraordinary have routinely been excluded from the clinical trials of all previously-known antidepressant drugs.”
Highlights
NRX-101 is NRx’s patented combination of the NMDA antagonist D-cycloserine and lurasidone, in Suicidal Treatment Resistant Bipolar Depression.
The Phase 2b/3 trial is a randomized, prospective, multicenter, double-blind study comparing NRX-101 to lurasidone over six weeks. No unexpected Serious Adverse Events were reported.
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 bipolar depression.
Bipolar depression is a lethal disease that claims the lives of one in five who live with it.
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 and Lotus 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, as well as a treatment for complicated UTI.
NRx has recently announced plans to submit a New Drug Application for HTX-100 (IV ketamine), through Hope Therapeutics, 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.
