NeuroRx, an Israeli start-up that is developing a treatment for depression, is the most innovative life science start-up in Israel, according to judges and attendees of the IATI-Biomed event in Tel Aviv this week.
The company recently published Phase II data, with research and funding from Herzog Hospital in Jerusalem and Columbia University in New York, for Cuclurad. It is a drug based on a molecule called D-cycloserine, which targets the brain’s NMDA receptor rather than the traditional serotonin pathway. The studies have been published and peer-reviewed.
NeuroRx was chosen out of dozens of companies that participated at the conference’s startup competition and met the required criteria, including addressing an unmet medical need. The panel of judges of the startup competition included an all-star lineup of top life science experts, who chose the technology developed by the company as one that could help doctors more successfully treat depression and suicide.
Cuclurad works by targeting the brain’s NMDA receptor, a part of the brain associated with memory, learning impairments, psychosis, and other conditions. Scientists know that it is activated when glutamate and glycine bind to it, and when activated it allows positively charged ions to flow through the cell membrane, thought to be critical in synaptic plasticity, important in learning andmemory.
Modulation of the NMDA receptor as a key to unlocking depression has gained widespread attention in scientific literature, according to the company. Today many doctors use ketamine to treat acute depression. Ketamine activates the NDMA receptor, and is fact is used itself to treat depression. Studies conducted by the company, as well as by independent organizations including the American Psychiatric Association, show that the formula used by Cuclurad – ketamine, along with D-cycloserine and one of three FDA-approved mood stabilizer – is much more effective than just ketamine.
The Phase II trial just completed indicates a reduction of symptoms within two hours of treatment; those positive results last for over eight weeks. Last October, the American Psychiatric Association Task Force on Novel Biomarkers and Therapeutics published the results of another study, in which it established that D-cycloserine “significantly reduced depressive symptoms without psychotomimetic and dissociative effects.” And, in another peer-reviewed independent study, Prof. Dan V. Iosifescu of the Icahn School of Medicine wrote in the Journal of Clinical Psychiatry that “the study [of Cyclurad] represents an important addition to the emerging literature on maintaining clinical response after an initial Ketamine treatment…D-cycloserine has several advantages. It can be administered orally and has demonstrated safety and tolerability for long term use.”
The company is expected to receive FDA approval under a fast track, following completion of clinical trials expected by the end of 2017.
Dr. Jonathan Javitt, founder and CEO of NeuroRx, said, “When someone dies from cancer, we blame the disease and look for a cure. Even though suicide is driven by chemical pathways in the brain, when people die of this disease, we tend to blame the patient. Our mission is to develop a first-in-class life saving drug for an unmet medical need, specifically suicide and depression.
“Suicide has long been viewed as an end stage of depression, when in fact it’s a distinct medical entity that appears to be driven by different brain pathways than those that drive depression. Every anti depressive drug on the market today is known to increase the risk for suicide even though it decreases symptoms of depression,” he added. “We now have exciting Phase 2 human data, both from Herzog Hospital in Jerusalem and from Columbia University in NY showing the potential of NMDA antagonist to be of enormous benefits for patients with depression and suicide.”