The Week In Psychedelics
Last week saw some interesting developments from two of the largest publicly-traded companies in the psychedelics space: MindMed and Atai Life Sciences. MindMed announced that the FDA has allowed it to advance with a phase 2 trial on LSD, the first commercial trial on the compound in over forty years. Atai launched a new portfolio company meant to assist its drug development efforts.
In the UK, the country's top health agency granted an “Innovation Passport” to MAPS for its MDMA program in the treatment of post-traumatic stress disorder. UK company Beckley Psytech commenced a therapist training program for an upcoming trial on 5-MeO-DMT, also known as "toad venom."
The movement for psychedelics legalization continues to spread across the country with new activist action in Colorado.
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UK's Top Health Agency Grants "Innovation Passport" To MAPS’ MDMA Program In Treatment Of PTSD
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FDA Approves First Commercial Clinical Trial On LSD In 40 Years
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ATAI Life Sciences Announces New Program To Discover Next-Generation Mental Health Treatments
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Colorado Activists Push For Psilocybin Legalization To Appear On 2022 Ballot
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Beckley Psytech Begins Training Therapists For Phase 2 Trial With Toad Venom, 5-MeO-DMT
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G2 Buys Peyote-Focused Psychedelics Company Lophos Pharma
- Novamind Stock Dives On $3.95M Private Placement With Institutional Investor
UK's Top Health Agency Grants "Innovation Passport" To MAPS’ MDMA Program In Treatment Of PTSD
The UK’s Medicines and Healthcare Products Regulatory Agency has granted an “Innovation Passport” to the drug MDMA, also known as “ecstasy” or “molly,” for the treatment of post-traumatic stress disorder.
The Innovation Passport, part of the Innovative Licensing and Access Pathway, is a designation by the country’s top health agency to reduce time to market for innovative medicines.
The designation was granted to the UK chapter of the Multidisciplinary Association For Psychedelic Studies, a nonprofit currently advancing a phase 3 trial with MDMA in the United States.
Similar to the FDA’s Breakthrough Therapy Designation, the Innovation Passport can help streamline access to MDMA as an adjunct to therapy for post-traumatic stress disorder.
FDA Approves First Commercial Clinical Trial On LSD In 40 Years
MindMed (NASDAQ:MNMD), a drug development company in the psychedelics space, announced on Tuesday that the FDA has allowed an investigational new drug application for a Phase 2b trial on a proprietary LSD analog.
The company is looking at generalized anxiety disorder as its main target indication.
The trial will focus on dose-optimization of MM-120, a “pharmacologically optimized form of LSD,” developed for generalized anxiety disorder and other brain-based disorders.
CEO Robert Barrow said this trial represents the first commercial study of LSD in more than 40 years.
The trial plans to enroll 200 participants who will receive either a single administration of MM-120 or a placebo.
ATAI Life Sciences Announces New Program To Discover Next-Generation Mental Health Treatments
Atai Life Sciences (NASDAQ:ATAI) on Thursday announced Invyxis, a new program to accelerate the company’s portfolio of compounds.
The clinical-stage biotechnology company focused on discovering and developing mental health treatments using psychedelic therapy said Invyxis would be its third approach to generating new compounds that improve the efficacy and safety of mental health treatments, joining EntheogeniX and TryptageniX.
Atai utilizes AI-powered chemistry in its EntheogeniX program, biosynthesis in TryptageniX and now high-throughput discovery chemistry through Invyxis. Atai said it would use Invyxis in tandem with EntheogeniX and TryptageniX to continue to find and develop revolutionary compounds to give patients access to treatments that are not currently available on the market.
Colorado Activists Push For Psilocybin Legalization To Appear On 2022 Ballot
Activists in Colorado are pushing for a ballot initiative that could legalize psilocybin and create a series of state-licensed healing centers where patients would be able to access treatment with the compound, also known as the active ingredient in “magic mushrooms.”
As Marijuana Moment reported, the Natural Medicine Healing Act would be included in Colorado’s 2022 ballot, and is now pending approval to begin gathering signatures.
On Wednesday, Colorado activists announced that they added modifications to their proposal, which originally included the possibility of legalizing various entheogenic substances including DMT, ibogaine and mescaline. The new language focuses on creating a legal and regulated therapeutic psilocybin program.
Beckley Psytech Begins Training Therapists For Phase 2 Trial With Toad Venom, 5-MeO-DMT
Beckley Psytech, a private company in the psychedelics space, announced that it has begun training psychotherapists for a Phase 2 clinical trial with 5-MeO-DMT, a strong and fast-acting psychedelic compound naturally produced by the Sonoran Desert Toad.
The company launched a program to study 5-MeO-DMT-assisted psychotherapy in patients with treatment-resistant depression, reaching over $100 million in private financing by August 2021.
“The initiation of this training programme is a vital step towards developing an ecosystem to support the emerging paradigm shift in how we treat neurological and psychiatric conditions,” said Cosmo Feilding Mellen, CEO of Beckley Psytech.
G2 Buys Peyote-Focused Psychedelics Company Lophos Pharma
Greenridez 2.0 Acquisitions Corp. confirmed Friday that it had completed its acquisition of psychedelic research company Lophos Pharma, which is primarily concentrated on new therapeutic treatments derived from Peyote (Lophophora williamsii).
The Toronto-based company confirmed that it supports Lophos Pharma’s belief in Peyote’s potential to treat indications ranging from weight loss and addiction to anxiety and depression.
Following the acquisition, Greenridez will be operating under the name Lophos Holdings and has appointed Claire Stawnyczy as CEO. Prior to joining the marijuana industry in 2017, Stawnyczy previously worked in the biotechnology space.
Novamind Stock Dives On $3.95M Private Placement With Institutional Investor
Novamind Inc. (OTC:NVMDF) announced a CA$5 million ($3.95 million) private placement with an institutional investor. The mental health company, specialized in psychedelic medicine, confirmed it has signed a securities purchase agreement with a single institutional investor for a private placement of its common shares and warrants.
Under the private placement, the company will issue 12.5 million shares and warrants to buy up to an aggregate of 12.5 million shares at a price of CA$0.40 per share and associated warrant.
Each warrant will entitle the holder to purchase one share at a price of CA$0.50 per share for a period of five years following the issuance date.
