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MEDIA REVIEW Dive Into the Public Narrative Around ATAI’S Work to Transform Healthcare for Hundreds of Millions Living with Treatment Resistant Mental Illnesses

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MEDIA REVIEW Dive Into the Public Narrative Around ATAI’S Work to Transform Healthcare for Hundreds of Millions Living with Treatment Resistant Mental Illnesses MEDIA REVIEW Dive into the public narrative around ATAI’s work to transform healthcare for hundreds of millions living with treatment resistant mental illnesses Table of contents Endpoints News: ATAI adds MDMA biotech to growing list of psychedelic makers . .2 FierceBiotech: From ‘party drug’ to PTSD treatment: EmpathBio to develop MDMA-based therapy . 3 Benzinga: ATAI Launches Subsidiary To Develop MDMA Derivatives . 5 pharmaphorum: Why the next blockbuster in mental health might be a video game . 9 Benzinga: ATAI Launches Subsidiary Focused On Active Ingredient In Hallucinogenic Brews . 12 FierceBiotech: Meet Viridia, the ATAI unit exploring ayahuasca-based treatments for mental illness . 13 Endpoints News: After psilocybin and ketamine, a biotech comes along developing a drug Scott Gottlieb fought . 15 Health Europa: Could ibogaine offer a revolutionary long-term solution to addiction? . 18 FierceBiotech: ATAI dives into digital therapeutics to boost mental health care . 21 Health Europa: Could arketamine be a breakthrough therapy for depression? . 23 UBS: Innovations in Mental Healthcare . 25 Forbes: Psychedelic Drugs Can Improve Quality Of Life - And Death - For Older Adults . 26 Endpoints News: Mushroom magic draws $80M injection for London-based mental health startup . 29 Forbes: Thiel Capital’s Jason Camm Discusses Joining Psychedelics Company ATAI Following $24 Million Raise . 31 Bloomberg: Thiel Backs Psychedelic-Drug Startup in Latest Funding Round . 33 The Sociable: Biotech startup wants to make new short-acting psychedelic drugs more scalable & accessible . 34 The European Pharmaceutical Manufacturer: How psychedelic medicine is being used to end opioid addiction . 37 Benzinga: Arketamine: A Fast-Acting Antidepressant Without Dissociative Effects? . 39 Endpoints: How do depressed rats respond to psychedelics? New data offer insight into the human experience . 42 Business Insider: Meet the top 9 startups raising millions to use psychedelics to treat depression, anxiety, and more. 45 Business Insider: ATAI is courting pharma and biotech investors as it looks to raise millions . 47 The New York Times: The Capital That Ate Wellness Is Going to Eat Your Mushrooms . 51 Business Insider: Investors eyeing psychedelics as the next big trend in healthcare . 53 FierceBiotech: ATAI, DemeRx pursue 'neurochemical reset' for addiction in $22M JV . 56 Bloomberg: A Hallucinogenic Root Is Pitched to Davos Set as Treatment for Opioid Addiction . 58 FierceBiotech: ATAI backs Neuronasal's through-the-nose concussion treatment . 59 Benzinga: The Keys To Understanding Psilocybin's Medical Value, Market Potential . 61 FierceBiotech: ATAI Life Sciences, Cyclica team up for mental health JV . 66 WSJ: The Power of Combining 5G and AI . 68 Vice News: Can a Trip-Free Psychedelic Still Help People With Depression? . 69 The Economist: Investors hope psychedelics are the new cannabis. Are they high? . 70 WSJ Pro Venture: Atai Life Sciences Is Assembling a Mental-Health Drug Platform . 71 STAT News: A German financier wants to turn magic mushrooms into modern medicine . 73 Business Insider: Evidence is mounting that psychedelic drugs can help treat diseases . 79 CNBC: Investors are starting to bet big on psychedelic medicine . 82 ATAI adds MDMA biotech to growing list of psychedelic makers Jason Mast | August 25, 2020 For years, the biggest push in psychedelic drug development has been around MDMA, a party drug long thought to have potential benefits for patients with PTSD. Rick Doblin, for years psychedelic therapy’s most prominent advocate and fundraiser, and his non-profit, MAPS, have raised millions to advance clinical trials, most recently raising $30 million to complete a Phase III study in veterans. But ATAI, the German-born biotech that has quickly become the most prominent private promoter and driver of psychedelic therapy, still thinks they have something to offer. Yesterday, the portfolio announced their latest subsidiary: EmpathBio. The idea behind EmpathBio is that Doblin’s approach, while promising, will only represent MDMA 1.0. In a a recent MAPS analysis of pooled Phase II studies – not a perfectly sound measure but good enough to support more studies – about half of the 100 patients who received the drug didn’t have the diagnostic symptoms for PTSD two months after their last dosing. The problem, said ATAI CSO Srinivas Rao, is that the drug has to be administered over multiple days in facilities where patients are supervised by trained professionals for hours. “The challenge with MDMA as it’s envisioned by MAPS is that it’s difficult to deploy and to scale up,” Rao told Endpoints News. “What we want to do is transition this more to an outpatient, or day-therapy type of approach, so we’re looking at compounds that are potentially safer.” The company remains far from the clinic, but they will work on MDMA-like compounds that they say have a better profile. With at least one other company, notably Kures, ATAI and its subsidiaries have tweaked generic, plant or other non-patentable molecules in large part to make them patentable, ensuring there’s a viable commercial pathway. But EmpathBio CEO Glenn Short pointed to the potential for some of these tweaks to reduce hypertension of MDMA, allowing it to be given patients with co-morbidities, as well as allowing it to be given over shorter periods of time and in less controlled settings, allowing patients to receive the drug in rural and other areas. 2 From ‘party drug’ to PTSD treatment: EmpathBio to develop MDMA-based therapy Amirah al Idrus | August 24, 2020 Treatment for post-traumatic stress disorder (PTSD) varies from patient to patient and can combine different kinds of therapy and drugs, including anti-anxiety meds and antidepressants. Problem is, the only drugs approved for PTSD don’t work for everyone, and even when they do, they don’t work perfectly and come with side effects. EmpathBio, ATAI Life Sciences’ latest company, is looking to fill that gap with treatments based on 3,4- methylenedioxymethamphetamine, better known as the “party drug” MDMA. The hope is that MDMA derivatives will work better as add-ons for patients with PTSD who are undergoing psychotherapy than antidepressants, such as Zoloft and Paxil, do. Accelerate Clinical Operations Across Sponsors, CROs, and Partners The most advanced life sciences organizations know that digital innovation and multi-platform integrations are essential for enabling product development. New platforms are providing the life sciences industry with an opportunity to improve the efficiency of clinical trials and reduce costs while remaining compliant and reducing risk. MDMA is a psychedelic, but it's not a traditional one like N,N-dimethyltryptamine (DMT)—the active ingredient in ayahuasca—or psilocybin, which is found in magic mushrooms. Instead, it’s thought of as an entactogen, meaning it can reduce anxiety, evoke feelings of empathy and sympathy and promote a sense of psychological safety. This puts patients in a place where they can process the intrusive thoughts and memories that characterize PTSD. “The idea is that this compound and compounds like it allow you to get some degree of comfort and also give you a better bond [with a therapist] to allow you to express these feelings and thus work through them,” said Srinivas Rao, M.D., Ph.D., chief scientific officer of ATAI Life Sciences. Compare that approach with using with Zoloft and Paxil, which work by boosting levels of serotonin—sometimes called the “feel-good” hormone—in the brain. They can rein in the emotional ups and downs that come with PTSD, but they can also hinder patients’ progress when undergoing psychotherapy. “When it comes to medically assisted therapy, they are not particularly great. They don’t really allow for opening up and facilitating a patient’s alliance with their therapist,” Rao said. 3 The Multidisciplinary Association of Psychedelic Research (MAPS) is already testing the MDMA approach in PTSD. Phase 2 data published in June showed that after two months of MDMA-assisted psychotherapy, more than half of 100 patients no longer met the diagnostic criteria for PTSD. And just last week, the nonprofit announced it had raised $30 million to bankroll phase 3 studies and an FDA submission for MDMA-assisted therapy as a treatment for PTSD. Unlike MAPS, which is running with MDMA itself, EmpathBio will develop derivatives of the compound with the goal of delivering its benefits without its downsides, such as increases in blood pressure or heart rate. “There are other side effects associated with MDMA and those are very mild to moderate, including anxiety, dizziness, fatigue and headache. Jaw clenching is a big one,” Glenn Short, the early development lead at ATAI, said. Creating a safer, more tolerable version of MDMA could open up the treatment to more patients, such as those who suffer from hypertension and could do without a drug that elevates blood pressure, he added. Throw in a digital therapeutic that can help doctors monitor patients and tailor their treatment, and MDMA-assisted therapy could reach patients who live far away from treatment centers. That would be an improvement over MDMA-based approaches in development, which would require patients to stay overnight while they are undergoing treatment. EmpathBio is in the lead selection stage of discovery and aims to move an MDMA derivative into human trials as quickly as possible. “We are obviously a number of years behind MAPS—they’re in phase 3 and that’s OK. We view this as a second-generation program,” Rao said. 4 ATAI Launches Subsidiary To Develop MDMA Derivatives Natan Ponieman | August 24, 2020 Psychedelics and biotech company ATAI Life Sciences announced on Monday the launch of a new subsidiary that will focus on the development of MDMA derivatives for the treatment of post-traumatic stress disorder and other indications. EmpathBio will be a wholly owned subsidiary of ATAI, led by CEO Glenn Short. The news comes days after the Multidisciplinary Association for Psychedelic Studies (MAPS) completed a $30 million fundraising that puts it one step closer to achieving FDA approval for MDMA-assisted psychotherapy in the treatment of PTSD.
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