atai's mission is to tackle the significant unmet needs and lack of innovation in the treatment ... [+] landscape by working with psychedelic and non-psychedelic compounds.
atai is one of the leading companies that is transforming the landscape of mental health using psychedelics. The company's mission is to tackle the significant unmet needs and lack of innovation in the treatment landscape by working with psychedelic and non-psychedelic compounds.
Currently, there are a number of treatments that are in development, some of which include MDMA for PTSD and ibogaine for opioid use disorder, alongside psilocybin (the active ingredient in magic mushrooms) and ketamine both for treatment-resistant depression.
Its part of an industry that is gaining a huge amount of interest and influence not only on the stock market, but amongst the wider public, regulators and politicians alike. Atai has also had a number of celebrity investors including the likes of Liam Payne, Diplo and Steve Bartlett who have all come out to show their support for the company.
I caught up with Co-Founder and CEO Florian Brand to find out more about his journey and the launch of the new atai Impact program.
For Part One of This Story, Click Here.
Afdhel Aziz:What are some of the treatments in development you are most excited about?
Florian Brand: It is of course difcult to pick a favorite. We anticipate 18 milestones for our platform companies through the end of 2022. The density of newsow is a result of our decentralized operating model combining aggressive business development with strong inhouse expertise of CNS drug development that have led to our extensive pipeline.
Were expecting several important milestones through the end of this year too. Perhaps the most anticipated for the psychedelic landscape is COMPASS Pathways Phase 2b study for psilocybin therapy for treatment resistant depression, which is expected to provide topline results in Q4 of this year. Psilocybin is derived from mushrooms, hence the term magic mushrooms, which have been used in various cultures around the world going back thousands of years.
Psilocybin has been extensively studied, both in work from the 1960s and, more recently, though ~50 years were lost due to prohibitions enacted around 1970. The data readout from COMPASS is indeed a major event for the whole industry, as this represents the worlds largest psilocybin therapy study, having completed psilocybin administration to 233 treatment resistant depression patients across 22 sites in 10 countries.
A second major milestone; we expect Recognify Life Sciences Phase 2a biomarker trial to have data by the end of the year for cognitive impairment associated with schizophrenia. This is another major indication for us. There are approximately 21 million people in the world who live with schizophrenia, and about 84% of schizophrenia patients suffer from signicant cognitive impairment.
Another 2021 milestone we anticipated and have already achieved is the initiation of a Phase 2 trial of R-ketamine for treatment of resistant depression. Ketamine, including the approved nasal spray with
S-ketamine, has helped people living with severe depression. We believe our approach with R-ketamine has the potential to be another major step in improving the treatment landscape in this much needed area. Our aim is to investigate the potential of this compound as the rst rapid-acting antidepressant approved for at home use due its putatively non-dissociative prole at effective doses.
A further key trial initiation was the recent launch of a Phase 1/2 opioid use disorder trial with ibogaine. Ibogaine is a naturally-occurring, psychedelic compound isolated from a West African shrub, that has demonstrated anecdotal pre-clinical potential of rapid and sustained efcacy in treating opioid use disorder.
Its hard to overstate the devastating effect of the opioid epidemic, which has only been worsened by the COVID-19 pandemic according to the CDCs numbers for 2020, drug overdose deaths shot up ~30% with close to 93,000 deaths, nearly 70,000 of which involved opioids.
Addiction is a complicated issue, but a key part we hope to address is the fact that it appears that current treatments simply arent good enough. With existing therapies, 75% of patients undergoing opioid use disorder therapy experience relapse within just 1 year. So, we desperately need new, better treatments.
Id also point to our efforts in anxiety disorders, which represent the most common mental health disorders in the US, with around 40 million people living with anxiety. It is personal for me, having suffered from debilitating anxiety when I was younger.
Our compound, GRX-917, is an oral formulation of a deuterated version of etifoxine, a compound that has a long history of prescription use in France for treating anxiety disorders. GRX-917 offers the promise, which our clinical trials will robustly assess, to provide rapid anxiolytic activity for potentially improved tolerability to current treatments for anxiety. We launched a Phase 1 trial in generalized anxiety disorder in the rst half of 2021.
"We have a bold vision, to heal mental health disorders so that everyone everywhere can live a more ... [+] fullled life." - Florian Brand, Co-Founder and CEO of atai
Aziz:Please tell us more about this idea of treating the patient and not the disease - by tailoring the experience using digital biomarkers?
Brand: We think that digital therapeutics (DTx) offers interesting applications as part of the treatment paradigm in mental health.
DTx has the potential to provide a more personalized, scalable treatment to those who might not otherwise be able to access high-quality psychological care and/or be limited in the benets received by current treatments. A major limitation to high-quality care is simply geography many patients live far away from treatment centers. And we envision DTx increasing access through tools like remote monitoring and counseling.
So, we plan to tightly integrate a digital strategy from the very beginning of development on a shared architecture across all compounds on atais platform. With digital biomarkers, clinicians may be able to predict patients recovery pathways, limiting trial and error, while streamlining therapeutic impact and better tailoring this to the individual.
With these tools, we intend to move towards precision psychiatry and personalized care which may help therapists to make the best decisions for their patients, meeting patients on their own terms. By using a variety of such digital biomarkers, we hope to make treatments increasingly rened, effective, and individualized.
Aziz:Finally, please tell me a little about atai Impact and its focus?
Brand: Today, we launch atai Impact, our philanthropic program established to support and collaborate with nonprofits and institutions that share atai Life Sciences' vision: to heal mental health disorders so that everyone, everywhere can live a more fulfilled life.
AtaiImpact has been developed to harness the power of innovative mental health approaches for positive social change. It will operate to advance education, expand access, and support the wider ecosystem.
It is part of our belief that a for-profit model is the best means of unlocking new modalities for patients in need, however, we recognize that commercial and non-profit entities standing shoulder to shoulder is the ideal way forward.
Through education, we want to help destigmatize mental health, promote better understanding of the potential of psychedelics in mental health care, and foster the next generation of neuro-innovators. By expanding access atai Impact aims to support equal access to innovative and effective mental health support, for everyone, everywhere, regardless of geography or demographics. Furthermore, the program will support the wider ecosystem by contributing to the sustainability of diverse stakeholder communities and environments, including indigenous resources.
The atai Impact program will initially be funded by 1% of the gross proceeds from atai Life Sciences June 2021 IPO and founders contributions. We have also created a Volunteer Paid Time Off Policy, equal to 1% of employees time, and are working with the Equity for Impact initiative to encourage employees and investors to donate a portion of their equity to charitable endeavors. We have been moved by the positive response and level of active support, both at atai and across our external stakeholders, and look forward to the many meaningful initiatives atai Impact will look to support.
The launch of this program marks a very proud moment for everyone at atai and provides us with another means of addressing the escalating mental health crisis.
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