Every second of every day, around the world, someone attempts suicide.
NRx Pharmaceutical is developing a drug for people with suicidal thoughts resulting from bipolar depression, the low mood phase associated with severe mood swings in bipolar disorder.
If the clinical trials go as planned, the company aims to commercialize the product in 2024.
“Bipolar depression accounts for only about 10 percent of all people with depression, but it accounts for about 40 percent of those who attempt to self-harm,” says Jonathan, founder and principal investigator at Nasdaq-listed company NRx. Dr. Javitt said. In 2021 he merged with NeuroRx.
“Suicidal bipolar depression is a devastating disease that pharmaceutical companies have never addressed. Currently, there are no FDA-approved drugs for suicidal bipolar depression.”
NRx’s multi-patented NRX-101 (Cyclurad) combines two FDA-approved medicines, the tuberculosis drug D-cycloserine and the anti-infective lurasidone. It is intended to be taken orally at home.
Most conventional antidepressants, which may actually increase suicide risk, target the serotonin pathway in the brain. NRX-101 acts on NMDA receptors in the brain. The NMDA receptor is a newly validated target for treating suicidal ideation and depressive symptoms, especially in bipolar depression.
A trial conducted at the Herzog Hospital in Jerusalem showed a significant effect of D-cycloserine (compared to placebo) in patients with treatment-resistant depression. And the effect of D-cycloserine in reducing suicide rate was demonstrated in one paper. independent trial in 2019.
The NRx drug candidate is also effective after injections of the anesthetic ketamine, which is effective in reversing depression, but only for about four days. Ketamine cannot be administered continuously because it causes hallucinogenic, addictive, and neurotoxic side effects. NRX-101 sustained the antidepressant effects of ketamine for two months without causing these unwanted side effects.
life of research
A trained ophthalmologist, Mr. Javitt has led eye disease and diabetes drug development programs at Allergan, Itech, Merck, Novartis, Pfizer and Pharmacia for the past 40 years.
But the research that formed the basis for the NRx drug candidate was started by his brother Daniel, a Jerusalem-based psychiatrist.
“Early in my brother’s career in the 1990s, he tried to understand why a drug of abuse called angel dust caused acute psychosis. He discovered that angel dust binds to NMDA receptors in the brain. I discovered that it was meant to be done,” says Jonathan Javitt.
He followed ongoing research in this area, including Dr. Robert Berman’s findings that drugs that bind to NMDA receptors may significantly reduce depression and suicidal ideation.
“Daniel has become one of the most published authors in the field of brain science,” says Javitt. “What we do is the natural result of that lifelong study.”
Herzog Hospital, where the first clinical trial of NRX-101 was conducted, is one of the founding shareholders, along with individuals including Chaim Hurvitz, a former Teva director and president of Teva International Group.
Commercialization in 2024
When ISRAEL21c first wrote about the newly formed company in 2015, the idea that NMDA antagonists could treat symptoms of depression was novel.
“Now it’s a well-tested idea,” says Javitt. “There are drugs in development, two have been approved by the FDA, and the science is widely accepted.”
But when NRx worked with the Israel Institute for Biological Research on novel coronavirus-related developments, the company’s psychiatric drug development was halted for about three years during the pandemic.
The NRX-101 program got back on track about a year ago.
“We are still the only company focused on bipolar depression, especially suicidal bipolar depression,” Javitt told ISRAEL21c.
Delaware-based NRx has completed its first Phase II trial leading to the FDA. Breakthrough therapy designation and special protocol agreements.
“We are currently doing a registry trial in suicidal bipolar depressed patients,” said Javitt.
He notes that this is the first known trial of a new antidepressant to successfully enroll patients with active suicidal thoughts.
“We expect completion by the end of the year and have already completed scale-up manufacturing to prepare for commercialization. We are targeting FDA approval for market entry in 2024.”
The same drug is also being tested to prevent suicidal thoughts in people with chronic pain in PTSD and depression.
“Since 9/11, we have lost more than four times. [US military] Veterans and military personnel are more likely to commit suicide than fight,” said Javitt, who has served as a medical adviser to four White House administrations.
NRx estimates the market potential for bipolar depression drugs at $2.2 billion, considering that approximately 7 million people have bipolar disorder and 9-10% of them suffer from suicidal thoughts. increase.
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