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MindMed seeks to harvest the power of psychedelics to treat mental health disorders

Snapshot

The New York City-based company has several projects in various stages from planning to ongoing clinical trials with a strong focus on legendary LSD

MINDMED LSD

Quick facts: MindMed

Price: 3.32 USD

OTCQB:MMEDF
Market: OTCQB
Market Cap: $1.08 billion
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  • Develops psychedelic medicines to improve health, promote wellness and alleviate suffering
  • Working with LSD, DMT, 18-MC, and MDMA as possible therapies for anxiety, addiction, cluster headaches, and adult ADHD  
  • Eyeing Investigational New Drug application to US FDA to treat anxiety disorders with LSD

What Mind Medicine does:

Mind Medicine (MindMed) Inc (NEO:MMED) (OTCQB:MMEDF) is a neuro-pharmaceutical company developing psychedelic medicines to improve health, promote wellness, and alleviate suffering.

The New York City-based company currently has several projects in various stages from planning to ongoing clinical trials involving the legendary drug lysergic acid diethylamide (LSD) as well as NDimethyltryptamine (DMT), the active ingredient in the ayahuasca plant, and 18-MC, a non-hallucinogenic molecule derivative of ibogaine from the African plant iboga.

The company also has a fourth drug in its research and development pipeline - MDMA. The compound may have the potential to treat mental health disorders. MindMed has acquired the exclusive license to nine completed clinical trials of MDMA at University Hospital Basel's Liechti Lab in Switzerland.

Also, at the Liechti Lab, MindMed’s researchers and clinicians are working on two other separate projects involving LSD treat anxiety disorders and cluster headaches (also known as suicide headaches). Both clinical trials are entering Phase 2.

The company is also advancing plans to launch a Phase 2 clinical trial in late 2020 to address adults suffering from attention deficit hyperactivity disorder (ADHD). The Liechti Lab and Maastricht University of The Netherlands will spear-head the study and hold trials in both countries.

In Australia, amid the coronavirus-related shutdowns and safety protocols, MindMed managed to remain on track for research on the treatment of opioid withdrawal and opioid abuse disorder. In July it completed a Phase 1 human safety trial of the 18-MC molecule, finding it well-tolerated. MindMed is planning to begin Phase 2 trials in the fourth quarter of 2020.

As for DMT, the company is providing startup funding to the Liechti Lab for a Phase 1 clinical trial, testing various intravenous dosing regimens. It is expected to begin in the fourth quarter of 2020, setting the stage for future potential Phase 2a proof of concept trials to understand how humans react to DMT, as it causes a rapid onset much like LSD. When administered as an ayahuasca brew, DMT can prolong experiential effects and slow metabolism. The company says the substance could help with addiction disorders.

The company has also noted that many mental health disorders appear to be interconnected. For example, 50% of ADHD patients (MindMed wants to treat adult ADHD symptoms as well) also suffer from anxiety disorders and the vast majority of patients with General Anxiety Disorder also have symptoms of another mental health problem, such as depression or substance abuse.

Given such data, MindMed sees a large opportunity to create a novel treatment platform that incorporates both experiential psychedelic-assisted therapy and non-hallucinogenic take-home medicines.

How is it doing:

MindMed has had a busy start to 2021 with news of two new studies, a partnership deal, and a batch of management changes.

On January 12, the firm announced an innovative randomized placebo-controlled study evaluating the effects of daytime and evening administration of low doses of LSD. 

The company said the study will look at how the low dosages affect cognitive performance, sleep quality, mood, neuroplasticity markers, emotion regulation, quality of life, and immune system response. 

The study also will provide an additional research pathway for MindMed's psychedelic Microdosing Division and will immediately integrate with MindMed's plans in digital therapeutics through its newly formed Albert unit for digital medicine. 

Then on January 20, MindMed announced the start of the first-ever clinical trial measuring and evaluating MDMA and LSD used in combination in the human body. 

The trial will be conducted at the University Hospital Basel Liechti Lab in Basel, Switzerland. If administered in combination with LSD, MindMed said that MDMA may increase positive subjective drug effects, including positive mood and empathy, and reduce the negative emotions and anxiety that are sometimes associated with LSD - producing an overall more positive experience.

On February 11, the company unveiled a new partnership with Swiss startup MindShift Compounds AG to develop and patent next-gen psychedelic compounds with psychedelic or empathogenic properties. 

As part of this partnership, both companies have agreed to develop next-gen psychedelic and empathogenic substances together.  MindMed said the first initial compounds have already been synthesized by MindShift Compounds and related patent applications were filed by MindMed. 

MindMed said it plans to begin first-in-human Phase 1 clinical trials as early as the first quarter of 2022, through its existing clinical trial platform for psychedelic and empathogenic compounds in Switzerland.

On the management front, unveiled some leadership changes as the company advances its strategy of combining clinical development programs with digital technologies. 

J.R. Rahn will become the sole chief executive of the psychedelic medicine biotech, while Stephen Hurst will retire from his co-CEO and executive chairman positions, but will remain a director. 

Stanley Glick has retired as a director but will continue to act as a scientific advisor, the firm added. His director role will be filled after completing an extensive search and interview process. Director Perry Dellelce becomes chair of the board of directors.

Thus, the MindMed team now includes Dr Miri Wernli Halperin as president and head of clinical and Carol Nast as chief operating officer, as well as Robert Barrow who was recently hired as the group's chief development officer.

MindMed announced the appointment of Barrow on January 14. He has over a decade of experience leading drug development programs aimed at identifying and testing novel treatments in a wide range of disease conditions under the US Food & Drug Administration (FDA) and the European medicines Agency (EMA).

In his most recent position, Barrow served as director of Drug Development & Discovery at the Usona Institute, where he oversaw preclinical, clinical and regulatory development efforts for all of Usona's development programs in psychedelics. At Usona, he was responsible for launching the Phase 2 clinical program for psilocybin in the treatment of Major Depressive Disorder and for obtaining Breakthrough Therapy Designation for the program at FDA.

With financials, back in November 2020, MindMed announced that it has a current cash reserve of US$37.8 million, or C$50.1 million, after closing a C$28.8 million financing on October 30, 2020. The company said its current cash position will enable it to continue to advance its clinical trial pipeline of psychedelic-inspired medicines and experiential therapies.

Inflection points:

  • News on placebo-controlled study evaluating the effects of daytime and evening administration of low doses of LSD
  • News on frst-ever clinical trial measuring and evaluating MDMA and LSD used in combination in the human body
  • Further details of new partnership with Swiss startup MindShift Compounds AG

What the broker says:

On February 11, analysts at Canaccord Genuity Capital Markets reiterated a Speculative Buy rating and C$5 price target on MindMed after the company announced its partnership with Swiss startup MindShift Compounds AG.

“[The deal] cements our view of MMED as the most diversified developer of psychedelic compounds across all for-profit companies,” Canaccord wrote in a note to clients. “With seven clinical programs and now two discovery partners, we look forward to MMED continuing to advance and expand its development pipeline.”

What the boss says:

Dr Miri Halperin Wernli, MindMed’s president and head of clinical development said in a recent statement: “Through the application of innovative medicinal chemistry and cutting-edge laboratory and computational technologies, we will expand the development of new, pure and well-characterized active ingredients for next-gen pharmaceutical psychedelic drug products.

“We are developing a pipeline of novel, patentable psychedelic drug candidates that are specifically engineered to improve on first-generation psychedelic compounds, targeting predictable pharmacokinetics and shorter half-life that will result in better efficacy and reduced toxicity. We expect that synthesizing these next-gen psychedelic derivatives will be very useful to create predictable, pharmaceutical-grade ingredients."

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MindMed takes another step forward adding MDMA to their R&D pipeline

MindMed (OTCQB: MMEDF) CO-CEO Jr Rahn joined Steve Darling from Proactive to announce the company has now added MDMA to its research and development pipeline. Rahn telling Proactive about some of the clinical studies they are doing including a new one called Project Lucy.

on 5/6/20

7 min read