New treatment aiming to reduce suicidality in Bipolar Disorder
American-Israeli company NRx is currently undergoing a trial that combines two kinds of compounds hoping to reduce the negative side effects of current medicine
Up to 50% of people with bipolar disorder attempt suicide over their lifetime, and estimates indicate that up to 20% may succumb to suicide. NRx, an American pharmaceutical company co-founded by Israeli citizens Jonathan Javitt, MD, and Daniel Javitt, MD, is aiming to significantly reduce these figures by developing therapeutics for the treatment of central nervous system disorders, specifically suicidal depression and post-traumatic stress disorder (PTSD).
NRx has announced that it has begun trials on a new medication that significantly reduces the risk of suicidality in Biopolar Disorder. The trial, set to finish in the third quarter of 2023, combines two drugs that both prevent the suicidal tendencies of Bipolar medication as well as the hallucinogenic side effects in current medicines.
“NRx just totally captivated me, because of the unmet medical need,” explained Steve Willard, who joined as the company’s new CEO earlier this year. “The degree of suicide in people with mental health issues, particularly Bipolar, is tremendous.”
Bipolar Disorder, formally known as Manic Depression, is a mental illness that causes unpredictable and unusual shifts in mood, energy, concentration, and the ability to carry out everyday tasks. Those who suffer from Bipolar typically experience extreme ‘ups’ in mania making up highly elated or irritable periods, followed by severe ‘downs’ that include periods of sadness, hopelessness, and depression. People suffering from manic episodes have trouble maintaining jobs and relationships due to their erratic behavior, while those experiencing depressive episodes are at high risk of dying by suicide. There are an estimated 7 million people in the U.S. with Bipolar at any given time - 10% of them are actively suicidal and 180,000 of those need to be under treatment in a hospital or care facility.
“In the United States, there's an attempted suicide every 27 seconds,” Willard explained. “If you were to know two Bipolar people, on average one would try to kill himself at some point in their life. And if you were to know five Bipolar people, one of them would succeed. It's a tremendous unmet medical need.”
Willard joined NRx after being approached by a headhunter after 27 years of experience in the biotech and pharma space. The company, which is headquartered in the U.S., was founded by two American brothers who have since made Aliyah and live in Israel. As Chief Scientist and Chair of the Scientific Advisory Board, the Javitt brothers are “actively involved in all our activities” and are monitoring and supporting trials intellectually.
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The company is tackling medication for Bipolar Disorder to help address the ‘black box’ issue of current Bipolar medicines like Lithium, which intend to numb or severely reduce emotions in sufferers to prevent suicide. Unfortunately, many of the medicines available for Bipolar contain warnings of hallucinogenic side effects when tackling a depressive state, but also warn against suicide ideation for the manic state.
NRx has been granted composition of matter patents in the U.S. and multiple international jurisdictions containing two types of drugs that both have anti-depressive qualities without the hallucinogenic attributes. “As a result, you get twice the depressive capability without the side effects,” Willard explained.
The 72-patient study is currently taking place at American hospitals among patients belonging to the group of 180,000 of whom have acute suicidal ideation. The company has a special protocol assessment with the FDA demonstrating the agency’s faith in the trial and hopes it will be available for distribution in the form of two pills twice a day by 2024.
As well as its work with Bipolar, the company is also conducting a trial in Israel to help address the suicidal tendencies found in PTSD. Its pre-clinical work is exploring fear memory, or fear conditioning, in which individuals predict aversive events. Sadly, Israel is an optimum field for research in PTSE due to the country’s national service and the impact conflict has on young minds. In total, NRx has 90 patents - 47 total and 43 applications - which cover a variety of biotech and pharmaceutical needs.
Earlier this month, the company announced that it had obtained approximately $11 million in unsecured debt financing from Streeterville Capital with the aim of using it to support its NRX-101 development programs.
