Update: MindMed Expands Psychedelic Pipeline and Receives Positive Human Data

In our first article covering MindMed, we shed some light on the growing mental health crisis that exploded during the pandemic. The stigma around anxiety and depression is slowly waning, but there is clearly an unmet medical need to develop novel treatments to address the…

• Over 280M people globally suffer from anxiety, resulting in $1T in lost productivity
• 300M annual prescriptions of opioids result in $2.5T spent on treating opioid addiction
• 16M adults in the US suffer from ADHD, resulting in $194B in lost productivity annually

MindMed is pioneering the development of a new therapeutic asset class to solve the untenable pathophysiology of mental health disorders. The core of their technology harnesses the neural “re-wiring” potential of psychedelic/hallucinogenic compounds (colloquially known as acid, DMT, and psilocybin - Learn more about psychedelics) to create new chemical entities that can be advanced through the FDA’s regulatory process. MindMed has formed a number of strategic collaborations with leading research institutes, such as the Liechti lab at the University Hospital Basel and Masstricht University, to assist in developing novel psychedelic-inspired compounds and conducting the rigorous clinical trials. Their diversified psychedelic pipeline is bolstered by drug asset acquisition (a Big Pharma strategy to drug development) in addition to in-house pharma research.

Key Developments (H2 2021)

Launch of R-MDMA program to treat anxiety and Autism Spectrum Disorder

MindMed has further diversified its expanding R&D pipeline with the launch of its R(-)-MDMA program to treat social anxiety and Autism Spectrum Disorder (ASD). Social anxiety and poor socialization skills are hallmarks of ASD, which affects 2% of the US population.  There are no approved treatments for ASD.  The economic burden of ASD is projected to surpass $461 billion by 2025, highlighting a significant unmet need for novel therapies. Additionally, ~12% of the US general population experience social anxiety at some point in their lives, according to the National Institute of Mental Health.

MDMA, which is a racemic mixture of two structurally unique stereoisomers, R(-) and S(+), is currently in development for the treatment of Post-traumatic Stress Disorder (PTSD), and has demonstrated statistically significant positive results in a pivotal Phase 3 trial.  In a pilot clinical trial, participants with ASD showed strong and statistically significant improvements in social anxiety and functioning from short-term treatment with MDMA.

MindMed’s innovation relies on the unique pharmacological activity of the R(-) stereoisomer, which maintains the pro-social and anxiolytic properties of the racemic mixture of MDMA while limiting side effects such as neurotoxicity, hyperthermia, and stimulant activity. MindMed plans to advance its R(-)-MDMA development program targeting US and EU registration and expects to initiate its first clinical trials in 2022.  As a key initial study, MindMed and the Liechti Lab at University Hospital Basel (UHB) plan to initiate a comparative pharmacokinetics and pharmacodynamic clinical trial of R(-)-MDMA, S(+)-MDMA and R/S-MDMA in 2022.  This double blind, placebo-controlled, crossover study will assess differences in acute and lasting effects between MDMA and its two enantiomers in healthy subjects and will provide important data on the optimal treatment model for R(-)-MDMA. [Read the press release here]

Positive results from psilocybin/LSD study

On September 23, 2021, the MindMed-University Hospital Basel (UHB) collaboration released the results from their LSD/psilocybin study and presented the positive data at the INSIGHT conference in Berlin, Germany. Their novel findings included two important pieces of data that will allow the company to design their clinical trials:

• Observation of psychedelic effects of 100 micrograms of LSD and an equivalent dose of 20mg psilocybin. This will be relevant when the company designs their Phase 1 and 2 dosing studies.
• Safety of psilocybin when administered alongside a SSRI (first-line treatment for depression), and the observation of acute psychedelic effects that were not diminished by the SSRI. This is relevant because future clinical trials will include patients that are being treated for depression using SSRIs, and it is to the patient’s benefit to maintain their SSRI treatments while participating in a psilocybin study to mitigate potential side effects (withdrawal from SSRIs can cause suicidal ideation).

“Investors and researchers alike are eager to understand the similarities between psilocybin and LSD. Learning how these substances compare and interact with other drugs helps us ensure that our treatment programs are as effective and efficient as possible.”

~ Robert Barro, MindMed’s CEO

Taken together, these results provide MindMed with a starting point dose for their psilocybin and LSD studies and give the company confidence that they can be completed safely in humans.

Initiation of Phase 1 clinical trial for DMT

On July 28, 2021, MindMed initiated their Phase 1 clinical trial to assess the safety, pharmacokinetics, and pharmacodynamics of DMT. DMT is a naturally occurring psychedelic and the active ingredient in ayahuasca (Learn more about the evolution of psychedelic-inspired medicine). The clinical trial is being conducted as an investigator-initiated study by Dr. Matthias Liechti as part of MindMed's ongoing collaboration with the UHB Liechti Lab and has received regulatory approval in Switzerland to begin enrollment. The Phase 1 clinical trial will include 30 healthy subjects in a randomized 5-period crossover, double-blind, placebo-controlled design. The outcome of the clinical trial will determine the dosing scheme for the following Phase 2 clinical trial to assess the efficacy of the drug along a dose range.

"We are very excited to start this study with Professor Matthias Liechti and University Hospital Basel. Currently no study has validly determined the elimination half-life of DMT or other pharmacokinetic parameters and our study will provide valuable information for future research on DMT as a tool to examine alterations of the mind. MindMed is exploring a number of psychedelic compounds as part of our mission to discover, develop and deploy psychedelic-inspired medicines and therapies to address mental illness and addiction. Our data driven approach drives our strategic choices for the development of both classical psychedelics and the very promising next generation novel chemical entities."

~ Dr. Miri Halperin Wernli, Executive President of MindMed

Expansive collaborations

On October 13, 2021, MindMed joined the Clinical Trials Transformation Initiative (CTTI) to contribute to developing the adoption of practices that increase the quality and efficiency of clinical trials. The CTTI is composed of 80 member organizations that seek to accelerate the discovery of new therapeutics by changing the way clinical trial data is aggregated and shared within the community.

"We welcome every meaningful opportunity to actively participate in the advancement of innovations that are ultimately contributing to the improvement of the way we develop medicine and bring treatment to the patient. MindMed and CTTI are both focused on improving clinical trials on behalf of patients and thus being a part of their mission aligns perfectly with the goals and values we have at MindMed. We look forward to being active partners in this initiative."

~ Daniel R. Karlin, MD MA, Chief Medical Officer of MindMed

On August 24, 2021, MindMed announced its collaboration with Forian, a SaaS solution to data management and analytics, to develop best practices for using real-world evidence to help improve treatment of psychiatric patients. Their mission relies on large, real-world health datasets to drive the discovery of connections that can be missed in individual, episodic health visits. Patterns emerge when data is tracked longitudinally across millions of patients.

"Our goal is to use real-world healthcare data and deep digital phenotyping to achieve in-depth, precise and personalized characterizations of individuals with generalized anxiety disorders and other conditions of interest for our drug development programs. By fully acknowledging each person's physiology, environment, and behavioral stressors, we ultimately aim for integrated digital deep diagnoses to drive precision psychiatry for drug development and clinical treatment across our target therapeutic areas."

~ Daniel R. Karlin, MD MA, Chief Medical Officer of MindMed

Addition of top-talent

• Dr. Maria Oquendo was appointed to the Scientific Advisory Board on November 5, 2021. Dr. Oquendo is Ruth Meltzer Professor and Chairman of Psychiatry at University of Pennsylvania and Psychiatrist-in-Chief at the Hospital of the University of Pennsylvania. A summa cum laude graduate of Tufts University, she attended Vagelos College of Physicians and Surgeons at Columbia University. She completed residency at the Payne Whitney Clinic of New York Hospital Cornell. She is a member of the National Academy of Medicine, one of the highest honors in medicine.
• Andreas Krebs was appointed as a Director on September 30, 2021. Mr. Krebs is an internationally experienced executive, entrepreneur and best-selling author ("The Illusion of Invincibility"). He heads the family-owned investment company Longfield Invest (Langenfeld/Germany), which focuses on growth companies in various industries as well as in the new economy. Andreas Krebs was Chairman of the Supervisory Board and Shareholder Council of Merz Pharma, Frankfurt am Main, Germany from 2010 to 2019, is currently a member of the Supervisory Board of the European eye clinic group Veonet (Nordic Capital Group) and holds other board positions across various sectors.
• Carol Vallone was appointed as a Director on September 30, 2021. Ms. Vallone is a well-known business leader, former CEO, and corporate board director, with a strong track record in launching, scaling and selling global companies. Currently, she serves as Chair of the Board of Trustees at McLean Hospital, the #1 ranked freestanding psychiatric hospital and largest psychiatric affiliate of Harvard Medical School; serves on the board of trustees at MGH Institute of Health Professions; and serves on the finance committee at Mass General Brigham. A serial entrepreneur, Ms. Vallone has served as founder & CEO of global e-learning companies, held manager positions in leading corporate technology companies and served on the boards of public financial services and e-commerce organizations.
• Dr. Bryan Roth was appointed to the Scientific Advisory Board on September 29, 2021. Dr. Roth has spent over 30 years studying molecular neuropharmacology. He is the Michael Hooker Distinguished Professor in the Department of Pharmacology at the University of North Carolina's (UNC) School of Medicine. He is also the director of the National Institute of Mental Health Psychoactive Drug Screening Program. Dr. Roth's research focuses on removing the hallucinogenic effects from psychedelic drugs; eliminating the hours-long hallucinatory trips that may turn some patients away from psychedelic-assisted treatments. He was among the first to publish in the scientific journal, Cell, the structure of how LSD binds to serotonin receptors within the brain. This structure is crucial to help scientists understand why psychedelics can have hallucinogenic and therapeutic effects.
• Robert Dworkin was appointed to the Scientific Advisory Board on August 10, 2021. Dr. Dworkin has spent over 35 years conducting clinical research on pain. He is currently Professor of Anesthesiology and Perioperative Medicine, Neurology, and Psychiatry, and Professor in the Center for Health + Technology, at the University of Rochester School of Medicine and Dentistry.

New intellectual property

On September 2, 2021, MindMed and BioXcel Therapeutics, a clinical-stage biopharma company utilizing artificial intelligence to develop novel treatments for psychiatric conditions, announced the publication of International Patent Application No. PCT/US2020/051256 (published as WO2021055595) for detecting and preventing the early onset of agitation in patients predisposed to highly agitated behaviour. The disclosure provides a method for measuring the signs of an impending agitation event and alerts the caregiver to treat the subject before agitation symptoms arise. Early intervention is the key to successfully treating diseases, and MindMed’s data-driven approach to identifying disease symptoms before they become severe is critical to patient well-being.

Technical Analysis

Is MNMD  poised for a breakout?

MindMed shares had a parabolic ascent from September 2020 through December 2020 before cooling and consolidating in a volatile range primarily contained between $2.50 and $4.00. The peak share price of $5.77 was reached on a spike high in April of this year when the company began trading on the Nasdaq. MNMD shares subsequently entered a 5-month downtrend that saw the share price fall roughly 60%. However, in recent weeks there are growing signs of accumulation and strong support near the $2.50 level. The chart setup is attractive with strong support slightly more than 10% below Friday’s close and ~50% upside to the upper end of the 52-week range.

Disclosure

Author owns MindMed shares at the time of publishing and may choose to buy or sell at any time without notice.