Madrigal Mental Care Develops Psychedelic Drug Treatment for Post-Traumatic Stress Disorder

Novel Nasal-Spray Nano-Formulation Enables Nose-To-Brain Delivery of Biodegradable Nanoparticles that can Encapsulate Psychedelic Substances such as Psilocybin

Madrigal Mental Care, a biopharmaceutical company developing a breakthrough delivery system for psychedelic drugs, introduced its novel nanotechnology for the treatment and prevention of post-traumatic stress disorder (PTSD) at Biomed Israel 2022, the premier international Life Science and HealthTech conference in Israel, on May 10-12, 2022, at the David InterContinental Hotel in Tel Aviv, Israel.

The advanced nanotechnology-based system is a breakthrough nasal spray that enables nose-to-brain delivery of organic nanoparticles. These biodegradable nanoparticles encapsulate molecules of psychedelic substances, such as psilocybin, the active ingredient in magic mushrooms, as well as ketamine, mescaline, MDMA and others. The nanotechnology was invented by Prof. Amnon Sintov, Department of Biomedical Engineering at Ben-Gurion University of the Negev (BGU) and was licensed from BGN Technologies, the Technology Transfer Company of BGU.

An increasing number of studies point to the advantages of using psychedelic drugs for the treatment of psychiatric disorders such as PTSD, depression, anxiety, obsessive compulsive disorder, and even addiction, with low doses,” said Prof. Sintov. “Due to their powerful effect on the human brain, it is imperative to be able to deliver these drugs in a safe manner and in precise doses. Our novel nanotechnology platform enables encapsulation of precise drug doses in nanoparticles that are delivered directly to the brain via an intranasal spray, in a very efficient, fast, and safe manner.

Our technology ensures a focused and fast delivery of accurate doses of psychoactive substances. The nanoparticles are biodegradable and provide a significant advantage over common practices in terms of stability and accuracy,” stated David Gabay, Co-Founder, and Chairman of Madrigal Mental Care. “In vitro studies, which were carried out by Prof. Shimon Ben-Shabat from the Department of Biochemistry and Pharmacology at BGU, show that the psilocybin doses used in the nanoparticles have a beneficial effect on inflamed brain cell cultures. We are currently beginning preclinical trials with rodents with the aim of achieving efficacy and safety approvals in order to begin first-in-human clinical trials next year. We have great confidence that this novel technology, that offers a new will propel forward the field of psychedelic-based treatments, for the benefit of millions of people around the world coping with chronic and acute psychiatric conditions such as PTSD and depression.”

Psilocybin mushrooms in Madrigal’s laboratories

Dr. Galit Mazooz Perlmuter, Senior Vice president of Business Development, Bio-Pharma at BGN Technologies, noted, “There is a vast need for better treatments for PTSD and other mental disorders. We have filed a patent application to protect this unique approach, which is an excellent example of the kind of breakthrough technologies originating from top scientists at the Ben-Gurion University.

About PTSD and Psychedelic Drugs

Post-traumatic stress disorder (PTSD) can affect people that experience traumatic or life-threatening events. People with PTSD find it difficult to perform daily functions for an extended period of time. Post-traumatic stress disorder symptoms may start within one month of a traumatic event, may also appear years later, and include significant problems in social or work situations and in relationships. PTSD symptoms are generally grouped into four types: intrusive memories, avoidance, negative changes in cognition and mood, and changes in physical and emotional reactions. It is estimated that approximately 3.5% of U.S. adults had PTSD in the past year.

Treatment of PTSD traditionally includes psychotherapy as well as medications that affect the neurotransmitters serotonin or norepinephrine (SSRIs and SNRIs). The remission rate of these treatments reaches approximately 50% at best, thus emphasizes the necessity of a novel approach. Recent years have seen increasing interest in treating PTSD with psychedelic drugs, including psilocybin (a 5HT2A agonist), MDMA (known as Ecstasy), and lysergic acid diethylamide (LSD). Since 2019, over 40 clinical trials have been launched exploring psychedelics for the treatment of psychiatric conditions, including PTSD. A Phase 3 clinical trial for treating PTSD with MDMA showed that two months after treatment, 67 percent of participants in the MDMA group no longer qualified for a diagnosis of PTSD, compared with 32 percent in the placebo group. Based on Databridge, the psychedelic market is expected to reach 40$ billion by 2027 in the medical arena alone.

About Madrigal Mental Care

Madrigal Mental Care aims to redefine the future of mental health care by using cutting-edge, breakthrough nanotechnology to deliver psychedelic drugs. The Company focuses on the treatment and prevention of post-traumatic stress disorder (PTSD). Madrigal Mental Care was founded in 2021 by David Gabay and Shahaf Maroodi and is based on research led by Prof. Amnon Sintov at Ben-Gurion University of the Negev (BGU), and licensed from BGN Technologies, the Technology Transfer Company of BGU.

About BGN Technologies

BGN Technologies is the technology transfer company of Ben-Gurion University, the third largest university in Israel. BGN Technologies brings technological innovations from the lab to the market and fosters research collaborations and entrepreneurship among researchers and students. To date, BGN Technologies has established over 100 startup companies in the fields of biotech, hi-tech, and cleantech, and has initiated leading technology hubs, incubators, and accelerators. Over the past decade, BGN Technologies has focused on creating long-term partnerships with multinational corporations such as Deutsche Telekom, Dell-EMC, PayPal, and Lockheed Martin, securing value and growth for Ben-Gurion University as well as the Negev region. For more information, visit the BGN Technologies website.

Read the original release here.

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