Company focuses on treating mental health and neurological disorders
Psychedelic Potential
Mind Medicine Inc., also known as MindMed, is a New York-based, early-stage biotechnology company focused on discovering, developing and deploying psychedelic based medications and treatment protocols, primarily derived from Psilocybin, LSD, MDMA, DMT and Ibogaine. Its pipeline is focused on treating a range of common mental health and neurological disorders, such as addiction, anxiety, depression and headaches. Leading the company are Chief Executive Officer and Co-Founder, JR Rahn, a former Silicon Valley tech executive; and President and Board Director, Dr. Miri Halperin Wernli, a thirty-year pharmaceutical and biomedical executive who previously served at several major pharmaceutical companies, such as Merck, Roche, and Actelion.
MindMed’s initial research entails acquiring and discovering new chemical products and treatment protocols. After these compounds and protocols go through FDA-regulated clinical trials, MindMed will try to secure partnerships with major pharmaceutical companies. Then, strategic affiliations with research centers, hospitals pharmaceutical companies and insurers will allow for the licensing of medications and protocols. MindMed was the first psychedelic pharmaceutical company to go public, listing on the Canadian NEO Exchange under the symbol MMED. It began trading on NASDAQ as MNMD in April 2021.
MindMed’s commercialization strategy is critical, because psychedelic inspired treatments are new products, and investors may be reluctant to monetize them. Encouraging to investors in MindMed might be the August 3 FDA approval of The Janssen Pharmaceutical Companies of Johnson & Johnson’s SPRAVATO (eskatamine), the first prescription nasal spray, for the treatment of depressive symptoms in adults with major depressive disorder, and treatment-resistant depression. It is the first FDA-approved drug for depression that does not work directly on monoamines, and it is the first psychedelic drug approved by the FDA for a psychiatric condition. This demonstrates the utility of psychedelic substances and supports the need for further research and development.
The current pipeline from MindMed includes 18-Methoxycoronaridine (18-MC), a novel derivative of Ibogaine, a naturally occurring psychoactive substance found in plants. It has demonstrated promising results in treating drug, alcohol, and nicotine addiction. The drug. which has a significantly improved safety profile and is shown to be neither psychoactive nor psychedelic, is currently entering Phase 2A trials for the treatment of opioid addiction.
Mind Med’s Project Lucy program is designed to develop and commercialize psychedelic assisted therapies for the treatment of anxiety disorder. Studies will evaluate experimental doses of LSD under supervision and in coordination with ongoing patient therapies. In 2020 MindMed completed a Pre-IND meeting with the FDA for Project Lucy, as well as preparations to open an Investigational New Drug (IND) in August of 2021, with a Phase 2B clinical trial for LSD assisted therapy.
The Albert Digital Medicine program uses digital therapeutics as evidence-based interventions guided by software for the treatment and prevention of diseases and disorders. These digital tools include wearable devices, machine learning and AI systems. Albert is an early-stage platform intended to develop a comprehensive toolset focused on delivering psychedelic-based treatments and therapies in combination with digital therapeutics. Dr. Miri Halperin Wenli is designing an experimental clinical trial that pairs psychedelic inspired medicines, such as LSD, with digital therapeutics to track, engage and influence patient behavior.
In July MindMed started a Phase 1 clinical trial to assess the safety, pharmacokinetics and pharmacodynamics of DMT, a naturally occurring psychedelic substance and an active ingredient in ayahuasca. The outcome of this Phase 1 clinical trial is expected to facilitate potential future Phase 2 clinical trials of DMT in patients. 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. The Phase 1 clinical trial has received all necessary regulatory approvals in Switzerland, and subject enrollment has begun.
MindMed is exploring DMT as a potential drug candidate given its potential advantages as a short-acting psychedelic. MindMed plans to study an intravenous administration method [during its Phase 1 clinical trial] that would induce a stable and prolonged DMT experience. The intravenous administration method may also allow greater control of the patient experience by enabling an acute termination of the psychoactive effects of DMT. DMT administration has a rapid onset and offset compared to the longer-acting psychedelic substances like psilocybin and LSD.
According to Dr. Halperin Wernli, “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. Our data driven approach drives our strategic choices for the development of both classical psychedelics and the very promising next generation novel chemical entities.”
The objective of the clinical trial is to assess the safety, tolerability and dose-response of DMT, including an assessment of the difference between infusion conditions. The Phase 1 clinical trial will include 30 healthy subjects in a randomized 5-period crossover, double-blind, placebo-controlled design.
MindMed has numerous other clinical and research partnerships. Its partnership with Swiss psychedelic drug discovery startup, Mindshift Compounds AG, is for the purpose of developing and patenting next-generation psychedelic compounds. Its relationship with New York University Langone Medical Center is intended to launch a clinical training program focused on psychedelic-assisted therapies and medications. Its partnership with Maastricht University, based in the Netherlands, has the ultimate objective of conducting clinical trials for the use of LSD in adult patients with ADHD.
Many brokerage firms have already submitted their reports for MNMD stocks, with Maxim Group repeating the rating for MNMD by listing it as a “buy.” The predicted price for MNMD stock in the upcoming period, according to Maxim Group, is $6 based on the research report published on June 28, 2021. Opinions of the stock are interesting as two analysts out of two who provided ratings for MindMed declared the stock was a “buy,” while none rated the stock as “overweight,” none rated it as “hold” and none as “sell.” The average price from analysts is $5.07. Currently, the average trading volume of MNMD is 8.67M shares.