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By Meg Flippin, Benzinga
The nation may be in a mental health crisis, with many people from the young to the old suffering from depression, anxiety, PTSD and suicidal ideation. The latter is particularly true for patients with bipolar depression. The disease, which afflicts 2.8% of the U.S. population, is marked by high highs and low lows. Thoughts of suicide accompany the depressive lows for nearly half of sufferers. Devastatingly, between 4% to 19% will commit suicide.
There are medicines available to help manage the highs and lows of bipolar disorder, but not a single-dose treatment. Typically, it requires one to manage mania and another for depression. They may not work for everyone and come with their own set of side effects.
Modifying The NMDA Receptor
NRx Pharmaceuticals Inc. (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, believes it has the answer with NRX-101. It’s the biopharmaceutical company’s FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. The company is targeting life-threatening diseases that often go untreated with NRX-101, which is a patented, oral fixed-dose combination of two FDA-approved drugs: D-cycloserine, an NMDA receptor modulator at certain dosage ranges; and Lurasidone, a 5-HT2a receptor antagonist.
Combined, the drugs target the NMDA receptor which is critical for memory function and the formation of new thoughts in the brain. At excessive rates of NMDA activity, ideas including the creation of new ones are slowed down. People with bipolar disorder tend to ruminate on fewer and more negative thoughts in that state. When the NMDA channel is blocked, thoughts can flow rapidly and incoherently, leading to hallucinations and psychosis. The challenge is to strike a healthy balance between the two. By modulating the NMDA, NRx believes it can improve the function of the thought-forming cells in the brain and thus reduce suicidal ideation. If approved by the U.S. Food and Drug Administration (FDA) and other health regulatory agencies, the company says it would be the first medicine regimen targeted to treat severe bipolar depression in patients with both acute and sub-acute suicidal ideation or behavior (ASIB and SSIB).
Trial Over-Enrolled
The company is taking steps to make that a reality, recently completing enrollment of a phase 2b/3 study of NRX-101 for 74 patients suffering from bipolar disorder. Enrollment exceeded the original target of 70 patients, to enhance the statistical power of the study, NRx said. Top-line data is expected later this month.
"To our knowledge, NRX-101 is the first and only oral medication to have demonstrated reduced suicidal ideation in patients with bipolar depression,” said Dr. Jonathan Javitt, Founder, Chairman and Chief Scientist of NRx Pharmaceuticals. “On the basis of our previous trial, it was awarded Breakthrough Therapy Designation by the FDA and we aim to confirm its effect on depression and suicidal ideation in this trial.”
NRX teamed up with Alvogen Pharmaceuticals for the development and marketing of the combined therapy. During its fourth quarter, NRx said Alvogen advanced its first $5.1 million milestone payment. A successful readout from the phase 2b trial and FDA interaction will trigger an additional $4 million milestone payment together with the transfer of future development costs to Alvogen. The partnership provides for potential milestones of $329 million and a royalty reaching 15% on net sales, according to NRx.
Beyond Bipolar Disorder
It’s not just bipolar disorder that NRx is aiming to treat with its NMDA therapy platform. The company is making inroads in using its lead compound in chronic pain, betting results of a 200-person efficacy trial conducted by Northwestern University could create a multibillion-dollar opportunity for NRx. Chronic pain is another condition that plagues more than 50 million Americans in which the available treatments have mixed results.
Then there’s its new drug application for IV ketamine in acute suicidality. NRx said it is building a specialty pharmaceutical business around ketamine it expects to yield positive cash flow by the end of 2024. Called HOPE Therapeutics, NRx plans to submit a new drug application with the FDA this year. In advance of FDA approval, HOPE partnered with national 503b and 503a pharmacies to address the ketamine shortage reported by the FDA since 2018. The goal is to spin HOPE out into a stand-alone company owned by NRx, current NRx shareholders via a tax-free dividend and new investors. NRx said prospective anchor investors offered $60 million in new investment dollars once HOPE is publicly listed. NRx said HOPE is presenting data from four randomized, prospective trials demonstrating safety and efficacy in 800 patients as the clinical basis for its new drug application (NDA) for HTX-100 (IV Ketamine).
And if that’s not enough, NRx recently received Qualified Infectious Disease Product (QIDP) and Fast Track designation from the FDA for NRX-101 in the treatment of complicated urinary tract infections (cUTI) and pyelonephritis. It's a condition the company says affects 3 million people in the U.S. resulting in over 15,000 deaths annually. NRx is currently seeking partners with active involvement in urology, infectious disease and/or women's health for commercialization of NRX-101.
"2023 was a pivotal year for NRx in which we advanced from a single clinical trial in a single indication to a dramatically streamlining operation with a 50% reduction in overhead costs, a 25% reduction in overall costs and a $0.20 per share improvement in negative earnings, while completing our clinical trial objectives,” says Stephen Willard, J.D., Chief Executive Officer and Director of NRx Pharmaceuticals. ‘We expect data from two key trials this month and predict our first commercial revenue by the end of 2024.”
Featured photo by Fernando @cferdophotography on Unsplash.
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