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MindMed Building Diverse Pipeline and Leadership Position in Psychedelic Inspired Medicines Industry

MindMed Building Diverse Pipeline and Leadership Position in Psychedelic Inspired Medicines Industry

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MindMed Co-founders and Co-CEOs JR Rahn and Stephen Hurst to provide corporate update of activities and investor Q&A on July 2, 2020 at 1pm EST

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New York, NY — June 26, 2020– MindMed, the leading neuro-pharmaceutical company for psychedelic inspired medicines is rapidly advancing its drug development pipeline and R&D activities since its listing on March 3, 2020.

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MindMed Co-Founder and Co-CEO JR Rahn said “Our progress in the past few months clearly demonstrates the quality of our team and the pace at which we operate as a company. We are honored to pioneer the fast growing psychedelic inspired medicines industry alongside peers including COMPASS Pathways, ATAI Life Sciences and non-profits MAPs, USONA and the Heffter Institute. There is a very clear distinction of the caliber of organizations advancing clinical trials to develop disruptive medicines for mental health and addiction and we look forward to continually raising the bar for the entire space and patients.”

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In furtherance of its mission to discover, develop and deploy psychedelic inspired medicines the company and management have executed on the below selected opportunities since listing on March 3, 2020:

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LSD (lysergic acid diethylamide)

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Experiential Therapies

• Added an ongoing Phase 2 clinical trial evaluating high dose LSD for the treatment of anxiety disorders in collaboration with the University Hospital Basel’s Liechti Lab.

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• Initiated Project Lucy, a high dose LSD psychedelic assisted therapy drug commercial development program for the treatment of anxiety disorders, intending to undertake a Phase 2b human trial.

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• Added and began treating patients in a Phase 2 clinical trial of LSD for Cluster Headaches in collaboration with University Hospital Basel’s Liechti Lab.

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• Filed a patent application for a LSD neutralizer technology intended to shorten and stop the effects of an LSD trip during a therapy session in collaboration with the University Hospital Basel’s Liechti Lab.

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• Acquired the exclusive license to 8 clinical trials and human safety studies of LSD at University Hospital Basel evaluating LSD.

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• Filed a patent application and are developing technologies and analytics that seek to personalize LSD assisted therapy experiences for a specific patient in collaboration with University Hospital Basel Liechti Lab.

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Microdosing Division

• Entered into a clinical trial agreement with Maastricht University to undertake a Phase 2a clinical trial for microdosing LSD in adult patients with ADHD intending to begin by the end of 2020.

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• Appointed Principal Investigators for Phase 2a clinical trial for microdosing LSD Dr Kim Krupyers (Maastricht University) and Dr Matthias Liechti (University Hospital Basel).

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• Added additional clinical trial site at University Hospital Basel for Phase 2a clinical trial at University Hospital Basel.

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18-MC (Opioid Use Disorder Program)

• Initiated and began dosing of a Phase 1 human safety trial of our 18-MC program for Opioid Use Disorder in Australia in the midst of COVID-19.

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MDMA (3,4-Methylenedioxymethamphetamine)

• Acquired the exclusive license to 9 completed clinical trials of MDMA at University Hospital Basel. Performing ongoing evaluation of data and opportunities to create new drug development programs to include MDMA

• Filed a patent application and are developing technologies and analytics that seek to personalize MDMA assisted therapy experiences for a specific patient in collaboration with University Hospital Basel Liechti Lab.

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DMT (N,N-Dimethyltryptamine, active ingredient in Ayahuasca)

• Providing startup funding to Liechti Lab for a Phase 1 clinical trial of DMT testing various intravenous dosing regimens, expected to begin in Q4 of 2020 setting stage for future potential Phase 2a proof of concept trials

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Corporate Development

• Appointed Johns Hopkins Professor and leading psychedelics researcher, Matt Johnson to its scientific advisory board

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MindMed Co-Founders and Co-CEOs will provide an update on operations and corporate activities, and will answer questions for shareholders on Thursday, July 2 at 1pm EST. Please sign up for Webinar here:

https://us02web.zoom.us/webinar/register/WN_pOzqk58eQaqgq_UZExDiHg

When: Jul 2, 2020 01:00 PM Eastern Time (US and Canada)

After registering, you will receive a confirmation email containing information about joining the webinar.

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About MindMed

Mind Medicine (MindMed) Inc. is a neuro-pharmaceutical company that discovers, develops and deploys psychedelic-inspired medicines to improve health, promote wellness and alleviate suffering. The company’s has initiated or is initiating studies to evaluate potential treatments to help patients with ADHD, anxiety, cluster headaches and substance abuse. The MindMed executive team brings extensive biopharmaceutical industry experience to this groundbreaking approach to the development of next-generation psychedelic medicines. MindMed trades on the NEO Exchange under the symbol MMED. MindMed can also be traded in the US under the symbol OTC: MMEDF and in Germany under the symbol DE:BGHM. For more information: www.mindmed.co.

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MindMed Forward-Looking Statements

This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Mind Medicine (MindMed) Inc. (“MindMed” or the “Company”), and actual events or results may differ materially from these forward-looking statements. Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying word. These statements concern, and these risks and uncertainties include, among others, MindMed’s and its collaborators’ ability to continue to conduct research and clinical programs (including those discussed in this press release), MindMed’s ability to manage its supply chain, net product sales of products marketed by MindMed and/or its collaborators (collectively, “MindMed’s Products”), and the global economy; the nature, timing, and possible success and therapeutic applications of MindMed’s Products and product candidates and research and clinical programs now underway or planned; the likelihood, timing, and scope of possible regulatory approval and commercial launch of MindMed’s product candidates and new indications for MindMed’s Products; unforeseen safety issues resulting from the administration of MindMed’s Products and product candidates in patients, including serious complications or side effects in connection with the use of MindMed’s Products and product candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict MindMed’s ability to continue to develop or commercialize MindMed’s Products and product candidates; ongoing regulatory obligations and oversight impacting MindMed’s Products, research and clinical programs, and business, including those relating to patient privacy; uncertainty of market acceptance and commercial success of MindMed’s Products and product candidates and the impact of studies (whether conducted by MindMed or others and whether mandated or voluntary) on the commercial success of MindMed’s Products and product candidates; the availability and extent of reimbursement of MindMed’s Products from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payers and new policies and procedures adopted by such payers; competing drugs and product candidates that may be superior to MindMed’s Products and product candidates; the extent to which the results from the research and development programs conducted by MindMed or its collaborators may be replicated in other studies and lead to therapeutic applications; the ability of MindMed to manufacture and manage supply chains for multiple products and product candidates; the ability of MindMed’s collaborators, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labelling, distribution, and other steps related to MindMed’s Products and product candidates; unanticipated expenses; the costs of developing, producing, and selling products; the ability of MindMed to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license or collaboration agreement to be cancelled or terminated without any further product success; and risks associated with intellectual property of other parties and pending or future litigation relating thereto, other litigation and other proceedings and government investigations relating to the Company and/or its operations, the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on MindMed’s business, prospects, operating results, and financial condition. Any forward-looking statements are made based on management’s current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by MindMed. MindMed does not undertake any obligation to update publicly any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.

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ATAI launches IntroSpect Digital Therapeutics, appoints veteran software engineer David Keene as CEO

LONDON and NEW YORK, June 22, 2020 /PRNewswire/ — Today, ATAI Life Sciences (“ATAI” or the “Company”), a global biotech developing psychedelic and non-psychedelic compounds for various mental health indications, announced the launch of its digital therapeutic platform IntroSpect Digital Therapeutics, Inc. (“IntroSpect”). David Keene, who brings almost two decades of experience in tech- and healthcare-related fields, will serve as CEO and will be leading ATAI’s efforts to bring digital therapeutics (DTx) and precision psychiatry to bear on the mental health epidemic.

”The ubiquity of mental illness mandates that we leverage emerging technologies to improve our ability to support patients wherever they may be,” said Florian Brand, CEO of ATAI Life Sciences. “David’s unique experience will be indispensable to helping us treat the individual rather than the disease.”

Before coming to ATAI, Keene worked as a software engineer and served in leadership roles at a variety of online retail and gaming companies. After a life-changing cancer diagnosis, David felt compelled to found Everystory, which became Dthera Sciences in 2016. As Chief Technology Officer, David led the development of DTHR-ALZ, an artificial intelligence-enabled device for Alzheimer’s disease with text messaging and complex emotional recognition capabilities based on cameras and facial landmark data. The device was one of the first that the FDA granted Breakthrough Device Designation for Alzheimer’s and went from inception to production in just 18 months.

“Using the flexibility and power of digital technology allows us to be more capable than ever of meeting patients on their own terms.” said Keene. ”By using a variety of digital biomarkers, we stand to make treatments increasingly refined, effective, and – most importantly for mental healthcare – individualized.”

ATAI’s DTx initiative will also pair the development of digital tools or devices with concurrent clinical research into certain compounds on the company’s platform to enhance their therapeutic impact, with the goal of delivering personalized and scalable treatments to those who might not otherwise be able to access high quality care. Moreover, by following a modular approach to development, technologies developed for one indication or compound will be more easily repurposed for others being studied by the company.

“With improved understanding of how individual biological phenotypes align with responses to certain interventions, clinicians will be better able to predict patients’ recovery pathways,” said Srinivas Rao, Chief Scientific Officer of ATAI Life Sciences.

“This, in turn, will cut down trial and error and shorten the time to therapeutic impact. And for those with difficult to treat mental illnesses, time is absolutely critical.”

Company Contact:
Allan Malievsky
ATAI Life Sciences
Phone: +1 (917) 974-1371
Email: Allan@ATAI.life

Investor Contact:
Allison Soss
KCSA Strategic Communications
Phone: +1 (212) 896-1267
Email: ATAI@KCSA.com

About ATAI Life Sciences
Founded by visionary entrepreneur Christian Angermayer, ATAI Life Sciences AG is a global biotech platform and company builder working to address significant unmet medical needs rooted in a lack of innovation in neuropsychiatry. Based in Berlin, London and New York, its vision is to cure mental health disorders, enabling people to live healthier and happier lives.

SOURCE ATAI Life Sciences

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Oregon psychedelic startup tests nasal spray for PTSD, depression as legislative momentum builds

Mike Arnold, the founder of Silo Wellness, on a trip to Jamaica. (Photo courtesy Mike Arnold)

If you want to know just how quickly public sentiment around psychedelics is changing, consider this: Gwyneth Paltrow sent her staffers to psilocybin-assisted therapy in the first episode of the Netflix docu-series the Goop Lab. Meanwhile, billionaires attending the World Economic Forum in Davos heard a pitch from a company developing a hallucinogenic drug to treat opioid addiction.

With Oregon activists pushing for state-wide decriminalization of magic mushrooms for therapeutic use this year, one local startup wants to keep the momentum going. Silo Wellness, based in Springfield, Oregon, has developed a nasal spray for microdosing psilocybin meant to aid with anxiety, PTSD and depression. The company now hopes to spread the good word, offering seminars for volunteers who normally wouldn’t try it on the black market to test the device in a controlled setting in Jamaica, where magic mushrooms are legal.

“My hypothesis being that this has the best chance of catalyzing legalization in the United States, when people go back and tell their peers and friends on Facebook that they tried mushrooms,” Mike Arnold, a former trial attorney and the founder of Silo Wellness, said in January before the COVID-19 outbreak.

Arnold says his goal is to “get psychedelics in the hands of as many people as quickly and inexpensively as possible.”

Almost 50 years after President Richard Nixon launched an anti-drug crusade, a growing number of researchers, companies and institutions are betting that the long-shunned hallucinogens could be poised for growth amid rising scientific evidence for their efficacy in treating some of the toughest mental health and addiction challenges.

Over 260 million people of all ages suffer from depression, which is a leading cause of disability worldwide, according to the World Health Organization. With the rise of awareness around mental health and mental illness, more startups are targeting the underserved market than ever before, says Stephen Hays, the founder of What If Ventures, which invests in early-stage mental health and addiction recovery focused companies.

More than 700 startups are building solutions for mental health and emotional well-being, with just over $4.5 billion invested, according to Hays’ estimates. About a dozen are focused on psychedelics, laying the groundwork in the anticipation of their removal from Schedule 1 category, which may happen in the next two years.

“Because the regulation is being crafted from scratch and the laws have to be changed, there are going to be a lot of people who start businesses and then get blindsided by the bureaucracy of the system,” said Hays. “It’s a really hard place to invest early without getting a little bit lucky.”

Earlier this month, the U.K.-based Compass Pathways, which is conducting the world’s first large-scale psilocybin therapy clinical trial, raised $80 million in a Series B round from investors, including ATAI Life Sciences, Founders Fund and Able Partners. The company, which holds a US patent relating to methods of treating drug-resistant depression “with a psilocybin formulation,” is also backed by Silicon Valley billionaire Peter Thiel, who has invested in other companies focused on psychedelics.

Meanwhile, Johns Hopkins University and Imperial College London last year opened new research centers, with more than $20 million in commitments from wealthy private donors, to study compounds like LSD and psilocybin for mental health disorders, depression and addiction.

Psilocybin is officially listed as an “eligible investigation drug” for terminally ill patients under the Right to Try Act passed by President Trump in 2018. According to one study, most cancer patients experienced “significant decreases in depressed mood and anxiety” after a session, while two-thirds said it was among the most meaningful experiences of their lives.

“For the first time in decades, psychiatry has a real shot at having approved treatments that not only alleviate the symptoms, but empower patients, and we simply cannot afford to miss that chance,” Ekaterina Malievskaia, chief innovation officer and co-founder of Compass Pathways wrote on LinkedIn in December.

Clockwise from upper left: Journalist Anastasia Ustinova, entrepreneur and consultant Eric Boone; Dr. Sunil Aggarwal, an affiliate clinical assistant professor at the University of Washington School of Medicine; and Mike Arnold, founder of Silo Wellness, recording an episode of the GeekWire Health Tech Podcast.

Oregon could become one of the first states to decriminalize the psychedelic mushrooms this year, with activists collecting signatures for several 2020 ballot initiatives, including for therapeutic uses. California and Vermont may follow suit.

Silo Wellness’s Arnold says he got involved in the industry for real purpose. After building a lucrative career as an “intimidating cross-examiner, a rugby-playing lawyer” with poor anger management skills, Arnold felt a profound transformation thanks to a guided meditation with a handful of magic mushrooms. That experience sent him on a quest to make the healing opportunities of fungi available to a much wider audience.

Thus was born the “spore to door” psychedelic therapy company, which formulated its product in Jamaica with a team led by pharmacologist Parag Bhatt and Marine combat veteran Scott Slay. Arnold also partnered with Michael Hartman, a former senior scientist at the pharmaceutical giant Novartis and the inventor of a cannabis and hemp inhaler.

The spray allows users to get the effects of a metered sub-psychedelic dose without the complications of an upset stomach. When inhaled, psilocybin goes directly to the bloodstream through the nasal membranes and eventually the liver for metabolizing. The company has no plans for commercial release yet.

Unlike with cannabis, where patients knew about the benefits of marijuana long before the capital market, this time high net worth individuals and institutional investors got on board early, which may create a threat for the industry, making it follow a big-pharma, prescription-only model, says Arnold.

“This is not the type of medicine you should have to go to a pharmacy and pay a lot of money for,” he said.

 Listen to GeekWire’s Health Tech Podcast above or subscribe in any podcast app to hear a discussion with Mike Arnold, founder of Silo Wellness; entrepreneur and consultant Eric Boone of Cannabinovation.com; Dr. Sunil Aggarwal, an affiliate clinical assistant professor at the University of Washington School of Medicine; and journalist Anastasia Ustinova.

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ATAI Life Sciences announces close of $24 million convertible note financing round and welcomes Jason Camm of Thiel Capital to Board of Directors

LONDON and NEW YORK, April 23, 2020 /PRNewswire/ — ATAI Life Sciences (“ATAI” or the “Company”), a global biotechnology company builder founded by Christian Angermayer that envisions an end to mental illnesses, today announced the close of a $24 million convertible note financing round. Despite market turmoil caused by the COVID-19 pandemic, the round saw strong support from both new and existing investors.

Several globally renowned investors like Peter Thiel as well as Steve Jurvetson and Maryanna Saenko of Future Ventures join ATAI’s numerous other reputable backers like Michael Novogratz’ Galaxy Digital, Thor Bjorgolfsson, Efrem Kamen, and ATAI founder Christian Angermayer’s Apeiron Investment Group, all of whom also purchased additional notes in the round.

“We are thrilled to have partners like Peter Thiel and Future Ventures with us for the next phase of our journey,” said Christian Angermayer, Founder of ATAI. “Both Peter and Steve have been prescient in identifying paradigm shifting enterprises and we’re honoured by their trust in ATAI’s vision.”

ATAI is recognized as the world’s leading mental health biotech company, leveraging a decentralized, tech- and data-driven platform that combines an emphasis on psychedelic compounds with non-psychedelics and artificial intelligence. ATAI’s portfolio currently includes: psilocybin for treatment resistant depression; ibogaine for opioid use disorder; arketamine for treatment resistant depression; deuterated etifoxine for anxiety; and a company designing next-generation psychedelic medicines using computational biophysics.

Additionally, Jason Camm, Managing Director and Chief Medical Officer at Thiel Capital, has joined ATAI’s Board of Directors, effective immediately. Jason drives Thiel Capital’s global biotechnology investment portfolio. He also serves as a Member of the Board at the Thiel Foundation, where he leads a team focused on science and medical philanthropy. Most recently, Jason was recognized as a Young Global Leader by the World Economic Forum.

“ATAI’s world class team and one-of-a-kind platform are driving much needed change in mental healthcare,” said Camm. “I’m excited to be joining them in bringing novel therapeutics to the millions who’ve been failed by currently available medicines.”

Finally, ATAI CEO & co-founder Florian Brand stressed the need to think of those with mental health issues in the midst of the ongoing COVID-19 pandemic: “Given the immediate and long-term mental health impacts of coronavirus containment efforts, the urgency of the mental health crisis will only grow. We are more committed than ever to ensuring people around the world have access to safe and effective treatment alternatives.”

Brand went on to thank Innoplexus, another ATAI portfolio company, for making its proprietary Ontosight® AI search platform freely available to medical researchers around the globe to help fight the COVID-19 pandemic.

Company Contact:
Allan Malievsky
ATAI Life Sciences
Phone: +1 (917) 974-1371
Email: Allan@ATAI.life

Investor Contact:
Allison Soss
KCSA Strategic Communications
Phone: +1 (212) 896-1267
Email: ATAI@KCSA.com

About ATAI Life Sciences
Founded by visionary entrepreneur Christian Angermayer, ATAI Life Sciences AG is a global biotech platform and company builder working to address significant unmet medical needs rooted in a lack of innovation in neuropsychiatry. Based in Berlin, London and New York, its vision is to cure mental health disorders, enabling people to live healthier and happier lives.

SOURCE ATAI Life Sciences AG

Related Links

www.atai.life

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ATAI Life Sciences Announces Joint Venture with DemeRx to Develop Ibogaine For Opioid Use Disorder

BERLIN and MIAMI, Jan. 24, 2020 /PRNewswire/ — ATAI Life Sciences AG (“ATAI” or the “Company”), a global biotech platform that envisions an end to mental illnesses, today announced an investment in two separate joint ventures (JV) with DemeRx, a clinical stage pharmaceutical company focused on developing ibogaine and noribogaine for the treatment of opioid use disorder (OUD).

OUD represents a significant unmet medical need, particularly in the United States. In 2018 alone, 2.1 million Americans met the diagnostic criteria for OUD, while 47,600 people died from opioid overdoses. Current treatment options for OUD are limited and carry risk of significant side effects and abuse potential. Overall, relapse rates across substance use disorders are estimated to be between 40 and 60%, due in part to the lack of effective therapeutics and low patient compliance.

Ibogaine is a natural indole alkaloid derived from the West African iboga plant and has previously been marketed as a stimulant and antidepressant in France under the brand name Lambarène. Known for its oneirophrenic and hallucinogenic properties, uncontrolled data from hundreds of patients suggest that ibogaine is effective as both an acute detoxifier and treatment for opioid addiction.

The largest study of ibogaine to date, an open-label case series of 102 opioid dependent and 89 cocaine dependent subjects in St. Kitts, West Indies, found that a single low, orally administered dose of ibogaine significantly reduced opioid withdrawal scores 36-hours post treatment, while also reducing the severity of cravings and depression in both cohorts. Importantly, these positive effects persisted at a one-month follow up.

“Not only were patients able to safely and successfully transition into sobriety, we found no evidence of additional abuse potential,” said Dr. Deborah Mash, CEO of DemeRx and principal investigator on the St. Kitts study. “Given the limitation in currently available treatments, ibogaine represents an enormous leap forward for OUD sufferers.”

While complications related to ibogaine have been documented, most such cases appear to be due to prior medical conditions or drug interaction. Of 19 recorded fatalities between 1990 and 2008, none were found to be the result of ibogaine’s toxicity. Nevertheless, ibogaine therapy is contraindicated for those with cardiovascular issues, particularly in cases of prolonged QTc Interval or hypertrophic cardiomyopathy. The ibogaine JV will involve developing a treatment protocol that includes proper screening procedures, dosing guidelines, and administration best practices to ensure patient safety.

Ibogaine affects a variety of neurotransmitter systems, including serotonin, opioid, and NMDA receptors. In humans, ibogaine is metabolized into noribogaine, which may itself have applications as a follow-up or maintenance therapy; its potential as a separate treatment will be evaluated in the noribogaine JV. Although the exact mechanisms behind ibogaine’s dissociative psychedelic effects are unclear, it has been speculated that the dream-like state induced in patients leads to a kind of “brain reset” that is important for the therapeutic effects observed.

Due to the extensive database for ibogaine, including a substantial amount of human data, ATAI and DemeRx plan to submit Clinical Trial Applications for a Phase II study in opioid-dependent patients.

“We are very concerned about the opioid epidemic in the United States and around the world,” said Florian Brand, CEO of ATAI. “Together with DemeRx, we are committed to developing novel approaches to both treat and prevent opioid addiction.”

“This addition to our platform is particularly meaningful for us because it rounds out our focus on the essentials of mental healthcare, namely depression, anxiety – and now – addiction,” added ATAI founder Christian Angermayer. “Our values are aligned with the needs of underserved patients, so we see it as our responsibility to tackle the opioid crisis head on.”

About ATAI Life Sciences
ATAI Life Sciences AG is a global biotech platform and company builder founded by Christian Angermayer. Based in Berlin, London and New York, its vision is to cure mental health disorders, enabling people to live healthier and happier lives. www.atai.life

Company Contact:
Allan Malievsky
ATAI Life Sciences
Phone: +1 (917) 974-1371
Email: Allan@ATAI.life

Investor Contact:
Allison Soss
KCSA Strategic Communications
Phone: +1 (212) 896-1267
Email: ATAI@KCSA.com

SOURCE ATAI Life Sciences

Related Links

http://www.atai.life

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ATAI Life Sciences Announces Joint Venture with DemeRx to Develop Ibogaine For Opioid Use Disorder

BERLIN and MIAMI, Jan. 24, 2020 /PRNewswire/ — ATAI Life Sciences AG (“ATAI” or the “Company”), a global biotech platform that envisions an end to mental illnesses, today announced an investment in two separate joint ventures (JV) with DemeRx, a clinical stage pharmaceutical company focused on developing ibogaine and noribogaine for the treatment of opioid use disorder (OUD).

OUD represents a significant unmet medical need, particularly in the United States. In 2018 alone, 2.1 million Americans met the diagnostic criteria for OUD, while 47,600 people died from opioid overdoses. Current treatment options for OUD are limited and carry risk of significant side effects and abuse potential. Overall, relapse rates across substance use disorders are estimated to be between 40 and 60%, due in part to the lack of effective therapeutics and low patient compliance.

Ibogaine is a natural indole alkaloid derived from the West African iboga plant and has previously been marketed as a stimulant and antidepressant in France under the brand name Lambarène. Known for its oneirophrenic and hallucinogenic properties, uncontrolled data from hundreds of patients suggest that ibogaine is effective as both an acute detoxifier and treatment for opioid addiction.

The largest study of ibogaine to date, an open-label case series of 102 opioid dependent and 89 cocaine dependent subjects in St. Kitts, West Indies, found that a single low, orally administered dose of ibogaine significantly reduced opioid withdrawal scores 36-hours post treatment, while also reducing the severity of cravings and depression in both cohorts. Importantly, these positive effects persisted at a one-month follow up.

“Not only were patients able to safely and successfully transition into sobriety, we found no evidence of additional abuse potential,” said Dr. Deborah Mash, CEO of DemeRx and principal investigator on the St. Kitts study. “Given the limitation in currently available treatments, ibogaine represents an enormous leap forward for OUD sufferers.”

While complications related to ibogaine have been documented, most such cases appear to be due to prior medical conditions or drug interaction. Of 19 recorded fatalities between 1990 and 2008, none were found to be the result of ibogaine’s toxicity. Nevertheless, ibogaine therapy is contraindicated for those with cardiovascular issues, particularly in cases of prolonged QTc Interval or hypertrophic cardiomyopathy. The ibogaine JV will involve developing a treatment protocol that includes proper screening procedures, dosing guidelines, and administration best practices to ensure patient safety.

Ibogaine affects a variety of neurotransmitter systems, including serotonin, opioid, and NMDA receptors. In humans, ibogaine is metabolized into noribogaine, which may itself have applications as a follow-up or maintenance therapy; its potential as a separate treatment will be evaluated in the noribogaine JV. Although the exact mechanisms behind ibogaine’s dissociative psychedelic effects are unclear, it has been speculated that the dream-like state induced in patients leads to a kind of “brain reset” that is important for the therapeutic effects observed.

Due to the extensive database for ibogaine, including a substantial amount of human data, ATAI and DemeRx plan to submit Clinical Trial Applications for a Phase II study in opioid-dependent patients.

“We are very concerned about the opioid epidemic in the United States and around the world,” said Florian Brand, CEO of ATAI. “Together with DemeRx, we are committed to developing novel approaches to both treat and prevent opioid addiction.”

“This addition to our platform is particularly meaningful for us because it rounds out our focus on the essentials of mental healthcare, namely depression, anxiety – and now – addiction,” added ATAI founder Christian Angermayer. “Our values are aligned with the needs of underserved patients, so we see it as our responsibility to tackle the opioid crisis head on.”

About ATAI Life Sciences
ATAI Life Sciences AG is a global biotech platform and company builder founded by Christian Angermayer. Based in Berlin, London and New York, its vision is to cure mental health disorders, enabling people to live healthier and happier lives. www.atai.life

Company Contact:
Allan Malievsky
ATAI Life Sciences
Phone: +1 (917) 974-1371
Email: Allan@ATAI.life

Investor Contact:
Allison Soss
KCSA Strategic Communications
Phone: +1 (212) 896-1267
Email: ATAI@KCSA.com

SOURCE ATAI Life Sciences

Related Links

http://www.atai.life

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ATAI Life Sciences Partners with Neuronasal Inc. to Develop Novel Treatment for mild Traumatic Brain Injury (mTBI)

BERLIN and WEXFORD, Pa., Jan. 6, 2020 /PRNewswire/ — ATAI Life Sciences AG (“ATAI” or the “Company”), a global biotech platform that envisions an end to mental illnesses, today announced that it has partnered with Neuronasal Inc., to develop a short-term treatment for mild Traumatic Brain Injury (mTBI) or concussion.

Neuronasal’s potentially ground-breaking, proprietary treatment includes the intranasal delivery of low doses of N-acetylcysteine (NAC) to patients with acute mTBI. NAC is a well-established compound that has been used safely for decades, mostly as a mucolytic and to treat acute paracetamol intoxication. NAC is a precursor of cysteine, stimulating the synthesis of glutathione which in turn is the most abundant endogenous antioxidant, known to prevent oxidative damage to cellular components. In addition, NAC itself has direct antioxidant, anti-inflammatory, and free radical scavenging effects. Finally, NAC acts as an inhibitory glutamatergic modulator. All of these mechanisms are important in the context of mTBI.

Concussions and other forms of mTBI represent a significant unmet medical need. With no currently approved treatments, patients often suffer acute symptomatology including headache, nausea, fatigue, depression, anxiety and irritability. In fact, approximately half of the 2.5 million people who are concussed every year in the United States alone develop long-term cognitive impairment. Also, the ongoing NINDS-funded track-TBI initiative has recently revealed that concussion is associated with substantial increases in the rates of major depressive disorder, post-traumatic stress disorder, and other psychiatric and non-psychiatric conditions.

“It’s clear that concussions and other mTBIs are more than just uncomfortable,” said Dr. Matthias Luz, Chief Medical Officer of ATAI Life Sciences. “In the hours and days after trauma, these injuries trigger a pathophysiological cascade that can result in significant, life-limiting conditions if not adequately addressed.”

Typically, concussions are the result of physical trauma that disrupts brain tissue and blood supply, followed by focal vascular leakage, inflammation, the formation of reactive oxygen species (ROS) and the release of excessive amounts of glutamate. This, in turn, exhausts the pool of intracellular glutathione in brain and induces glutamate-mediated neuro-excitotoxic damage. In more severe cases, neuronal atrophy and necrosis can occur as well.

NAC has the potential to disrupt the deleterious chain of events following mTBI. In soldiers exposed to explosive blast injury, NAC treatment, as compared to placebo, increased the probability of symptom resolution at 7 days from 41.9 to 86.2% when administered within 24 hours post-blast.

A particular problem with the use of NAC is the blood-brain barrier which effectively shields the brain from many drugs including NAC. When administered orally, several grams of NAC are required to reach the requisite drug concentrations in brain, doses which often cause significant side effects like nausea and diarrhea. Intravenous drug administration allows for slightly lower doses but requires several days of inpatient care and often leads to dizziness and headache.

By contrast, Neuronasal’s intranasal approach enables direct nose-to-brain delivery, allowing for significantly lower doses and outpatient treatment. Given its apparent efficacy in disrupting the underlying neurochemical cascade, intranasal NAC has the potential to induce a fundamental shift in the natural course of the condition for hundreds of thousands of people.

“Neuronasal has the potential to transform the way we treat those most at risk of mTBI, with applications in sports, the military, and daily life,” said Thomas Bradshaw, CEO of Neuronasal. “Unsurprisingly, we’ve seen incredible interest from everyone from the Department of Defense to the National Collegiate Athletic Association.”

A pilot study exploring the effects of intranasal NAC administration on regional brain glutathione concentrations in healthy volunteers is expected to begin in February.

About ATAI Life Sciences
ATAI Life Sciences AG is a global biotech platform and company builder founded by Christian Angermayer. Based in Berlin, London and New York, its vision is to cure mental health disorders, enabling people to live healthier and happier lives. www.atai.life

Company Contact:
Allan Malievsky
ATAI Life Sciences
Phone: +1 (917) 974-1371
Email: Allan@ATAI.life

Investor Contact:
Allison Soss
KCSA Strategic Communications
Phone: +1 (212) 896-1267
Email: ATAI@KCSA.com

SOURCE ATAI Life Sciences

Related Links

https://www.atai.life

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GABA Therapeutics and ATAI Life Sciences Partner to Develop a Novel GABA Modulator for the Treatment of Mood Disorders

NEWPORT BEACH, Calif. and BERLIN, Sept. 20, 2019 /PRNewswire/ — Today, GABA Therapeutics, a biotech company focused on the treatment of mood disorders, and ATAI Life Sciences, a global biotech company builder working on paradigm shifting interventions for unmet needs in the mental health space, announced a partnership to develop a novel compound that promises efficacy across a spectrum of mood disorders, particularly anxiety and depression.

GABA Therapeutics’ lead compound, GRX-917, is a deuterated version of etifoxine, a safe and effective anxiolytic medication approved in approximately 40 countries with rapid onset and efficacy comparable to leading benzodiazepines like alprazolam (Xanax™) and lorazepam (Ativan™). In contrast to these and other benzodiazepines, however, more than 30 years of clinical experience with etifoxine suggest that GRX-917 is unlikely to produce serious side effects like sedation, amnesia, tolerance or physical dependence.

“GABA’s work with GRX-917 is critical for addressing the needs of millions of people living with treatment resistant mental illnesses,” said Florian Brand, CEO & Co-Founder, ATAI Life Sciences. “By providing a safe way to meaningfully alleviate anxiety, not only will we improve peoples’ quality of life, we’ll also help them to better engage with their care providers.”

Notably, etifoxine is thought to achieve its anxiolytic activity by increasing central levels of neurosteroids, endogenous compounds (e.g. allopregnanolone) with potent antidepressant, neuroprotective, neurotrophic and anti-inflammatory properties, thereby affording GRX-917 the potential to treat a broad range of CNS diseases. With an improved pharmacokinetic profile that enables less frequent and lower dosing regimens, GRX-917 represents a leap forward for patients seeking to manage their anxiety acutely, safely and reliably.

The Series A investment of up to $15.5 million will fund the program through a Phase 2a proof-of-concept study.

“We are very pleased to partner with the team at ATAI,” said Dr. Ian J. Massey, CEO, GABA. “They are building a world-class portfolio of mental health companies and GRX-917’s potential to address the immense unmet medical need of unmanaged anxiety makes it a natural addition. We are grateful to have the funding and support of ATAI to drive forward this important program.”

“We are thrilled to partner with GABA and will fully support all efforts to bring GRX-917 to patients as quickly as possible,” added Christian Angermayer, Founder, ATAI Life Sciences.

About ATAI Life Sciences

ATAI Life Sciences AG is a global biotech platform and company builder founded by Christian Angermayer. Based in Berlin, London and New York, its vision is to cure mental health disorders, enabling people to live healthier and happier lives. www.atai.life

About GABA Therapeutics

GABA Therapeutics is a California based biotechnology company focused on developing its lead compound GRX-917 for anxiety, depression and a broad range of neurological disorders. GRX-917 has the potential to become front-line therapy for anxiety and has composition-of-matter patent protection until 2036. Moreover, preclinical studies using etifoxine have demonstrated efficacy in a broad range of other neurological disorders, including pain, multiple sclerosis, epilepsy and Alzheimer’s disease.

For more detailed information on GABA Therapeutics, visit www.gabarx.com.

About Anxiety

Anxiety, which is frequently comorbid with depression, is the largest mental health issue in North America. It is estimated that one third of the North American adult population experiences anxiety issues, yet only one third of sufferers receive treatment, of whom only 10% experience any form of remission. This is largely due to limitations in current therapies. In 2018, there were approximately 140 million prescriptions of anxiety medications in the United States(2).

(1)  anxietycentre.com
(2)  IQVIA market data – 2018

Contact
Richard G Farrell
Chief Financial Officer
rfarrell@gabarx.com

Allan Malievsky
Communications Associate
Allan@ATAI.life

SOURCE ATAI Life Sciences

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https://www.atai.life