Psychedelics Drug Development

"Mushrooms are miniature pharmaceutical factories, and of the thousands of mushroom species in nature, our ancestors and modern scientists have identified several dozen that have a unique combination of talents that improve our health".

By Paul Stamets

According to Data Bridge Market Research, the psychedelic drug market is projected to grow at a CAGR of 16.3% over the next eight years to reach $6.85 billion by 2027, and an increasing prevalence of depression and other mental health disorders in the western world will fuel this growth.

So far, Johnson & Johnson's SPRAVATO (esketamine) a nasal spray for treatment-resistant depression was the first psychedelic drug to gain FDA Breakthrough Therapy designation in March 2019. On 12 January 2022, FDA has authorised German psychedelic startup Atai Life Sciences 🍄 to conduct a clinical trial on a nonpsychedelic form of ketamine for treatment-resistant depression. On January 25, 2022, FDA has cleared MindMed's 🍄 Investigational New Drug application, allowing the company's phase 2b dose optimisation trial of MM-120 (MM-120 is MindMed's proprietary drug candidate, a pharmacologically optimised form of LSD) for the treatment of generalised anxiety disorder to proceed. And Numinus Wellness Inc. 🍄 became the first publicly-traded company in Canada to be granted a licence to conduct research to standardise the extraction of psilocybin from mushrooms.

Let's see now the best psychedelics companies to consider in 2022, that are growing rapidly, even though they have relatively low market capitalisations (source):

Cybin (NYSEMKT:CYBN) $148 million

Cybin (@CybinInc) 🍄 is a mushrooms-focused life sciences company, that aims to become one of the first life sciences companies to launch a fully approved psilocybin product targeting depression. In particular, Cybin received in 2021 an approval from the University of the West Indies Hospital in Jamaica for a phase II trial of its psilocybin formulation CYB001, to treat major depressive disorder. This trial will assess Cybin’s sublingual psilocybin formulation versus a 25mg psilocybin capsule.

Currently, they are working on the following projects growing their "Research and Development Pipeline":

• Mental Distress in Healthcare Workers: EMBARK – Psilocybin for mental distress in frontline healthcare workers
• Psychedelic Effects On Brain: Kernel Flow - Neuroimaging Technology (Kernel Flow is a non-invasive brain interface which records real-time, cortical hemodynamics to establish precise patterns of brain activity.)
• Major Depressive Disorder: CYB003 - Deuterated Psilocybin Analog
• Alcohol Use Disorder: CYB003 - Deuterated Psilocybin Analog
• Anxiety Disorders: CYB004-Deuterated Dimethyltryptamine (DMT)
• Neuro-inflammation: CYB005-Phenethylamine Derivative

And they have the following "Clinical Alliances" with:

• University of Washington: Psychedelic-assisted psychotherapy with psilocybin for mental distress in frontline healthcare workers
• Kernel Technology: Measuring ketamine’s psychedelic effect on cerebral cortex hemodynamics
• Northwell Health, Lenox Hill Hospital: Psychedelic treatment for underserved communities and COVID-19 distress in frontline workers.

On February 15, 2022, Cybin announced a partnership with The Chopra Foundation, a not-for-profit organisation founded by Dr. Deepak Chopra dedicated to improving health and well-being. Both will work closely to support education and awareness about Cybin's groundbreaking research to harness the potential of psychedelic therapies in mental health.

Atai Life Sciences (NASDAQ:ATAI) $860 million

ATAI Life Sciences (@atai_life) 🍄 describes itself as a “global biotech company builder” with offices in Berlin, New York and Amsterdam. The company is acquiring and efficiently developing psychedelic treatments that address significant unmet medical needs in the mental health space.

They have a strategic investment with Compass Pathways, a Top HealthTech Company in Europe developing psychedelic therapies, and different joint ventures with:

• Perception Neuroscience, a biopharmaceutical company committed to develop therapies for neuropsychiatric diseases. Atai Life Sciences just announced its plan to begin a clinical drug-drug interaction study via its majority-owned subsidiary Perception Neuroscience starting early in 2022, evaluating its investigational new drug PCN-101 (R-ketamine), against treatment-resistant depression.
• Recognify Life Sciences, with positive topline data from its Phase 2a study in cognitive impairment associated with schizophrenia, for its lead compound RL-007 (a GABA / nicotinic modulator).
• DemeRx, a clinical stage pharmaceutical development company advancing drug candidates (ibogaine and noribogaine) as medication-assisted therapies for opioid addiction.
• GABA Therapeutics, a biotechnology company focused on developing its lead compound GRX-917 (a deuterated version of etifoxine) for anxiety, depression and a broad range of neurological disorders.
• Neuronasal, has completed its pilot study intended to show nose to brain delivery of N-acetylcysteine (NAC).
• Viridia, is working on a new DMT formulation and hopes to develop a framework like Spravato, the ketamine nasal spray, which patients can take during a 2h visit to the doctor.
• EmpathBio, focused on developing MDMA derivatives with different pharmacological profiles than MDMA.
• Revixia, developing Salvinorin A (derived from Salvia divinorum, SalA is a unique non-nitrogenous agonist of the kappa-opioid receptor) for a variety of mental health conditions. And
• Kures, which targets the important intersection between pain and opioid use disorder.

Finally, the Multidisciplinary Association for Psychedelic Studies, better known as MAPS 🍄, just announced that it has accepted a US$500,000 donation from atai Impact, the philanthropic arm of Berlin-based atai Life Sciences.

Compass Pathways (NASDAQ:CMPS) $553 million

Compass Pathway (@COMPASSPathway) 🍄 an ATAI company has created a synthesised version of psilocybin named COMP360 and in 2018 the FDA gave the company’s drug candidate “breakthrough therapy” status for treating clinical depression. COMP360 treatment is administered alongside guided talk therapy, and early studies showed that the combination is highly effective at treating people with treatment resistant depression.

The company just announced:

• positive results from a phase IIb COMP360 psilocybin therapy trial for treatment-resistant depression and rapid and sustained response for patients receiving a single 25mg dose of COMP360 psilocybin with psychological support,
• an end-of-phase II meeting scheduled with FDA for late April 2022,
• a phase III programme expected to begin in second half of 2022, and
• the launch of a phase II study of COMP360 psilocybin therapy for post-traumatic stress disorder.

Numinus Wellness (OTC:NUMI.F) $84 million

Numinus (@NuminusWellness) 🍄 combines time-tested holistic methods with the power of neuro-technology to bring holistic healthcare to patients, and was acquired by Salvation Labs a multifaceted tech-forward cannabis and cannabidiol company.

Numinus is offering the following services:

• Ketamine-Assisted Psychotherapy for the treatment of depression, while treatment for other conditions such as anxiety, PTSD and Substance Use Disorders are under development and will be available soon.
• Psychotherapy.
• Psychedelic Integration such as education, therapy and coaching.

Numinus Bioscience is conducting clinical trials with both MDMA and psilocybin, and is preparing for the eventual roll-out of these therapies to the general public. In particular, Numinus has partnered with MAPS for a single-arm, open-label, compassionate access trial for MDMA-assisted therapy for PTSD, and has partnered with Syreon Corporation to pursue a single-arm, open-label compassionate access trial of Psilocybin-Research Intervention with Motivational Enhancement for substance use disorders.

Mind Medicine (NASDAQ:MNMD) $454 million

The Toronto-based MindMed (@mindmedco) 🍄, which became the world’s first publicly traded psychedelic pharmaceutical company, has just announced the results of a study directly comparing the acute effects of Lysergic Acid Diethylamide (LSD) and psilocybin in healthy subjects. The data indicated that the key differences between LSD and psilocybin are dose-dependent rather than substance-dependent.

They are also developing 18-MC to treat addiction, rather than solely the symptoms and microdosing (refers to a smaller, non-hallucinogenic dose) of LSD for macro healing.

On January 25, 2022, FDA has cleared MindMed’s Investigational New Drug application, allowing the Company’s Phase 2b dose-optimisation trial of MM-120 for the treatment of generalised anxiety disorder to proceed. MM-120 is a pharmacologically optimised form of LSD being developed for generalised anxiety disorder and other brain-based disorders.

Seelos Therapeutics (NASDAQ:SEEL) $107 million

Seelos Therapeutics, Inc (@seelostx) 🍄 Seelos intends to become a leading biopharmaceutical company focused on neurological and psychiatric disorders.

The company was awarded fast track designation by the FDA for its investigational intranasal racemic ketamine program (SLS-002). This program explores ketamine—an anesthetic medication—for the treatment of Acute Suicidal Ideation and Behaviour in patients with Major Depressive Disorder. SLS-002 was originally derived from a Javelin Pharmaceuticals, Inc./Hospira, Inc. program with 16 clinical studies involving approximately 500 subjects. Experimental studies have suggested so far that ketamine has the potential to be a rapid, effective treatment for refractory depression and suicidality.

their

This is their pipeline as of December 2021:

• SLS-002 intransal ketamine for Major Depressive Disorder

• SLS-003 sublingual ketamine for Complex Pain Syndrome: In November 2021, Seelos licensed SLS-003 from iX Biopharma for Wafermine™ (sublingual racemic ketamine wafer) and a worldwide license for other sublingual ketamine wafers formulations.

• SLS-005 trehalose for Amyotrophic Lateral Sclerosis and Spinocerebellar Ataxia
• SLS-004 gene therapy for Parkinson's Disease, and
• SLS-007 gene therapy for Parkinson's Disease

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Reference 📚: Psychedelics Drug Development Startups 🍄

Psychedelics Drug Development: Startups, Clinics, Investors and Non-Profit (part 1)

Psychedelics Drug Development: Startups, Clinics, Investors and Non-Profit (part 2)

Psychedelics Drug Development: Startups, Clinics, Investors and Non-Profit (part 3)