MindMed Inc (NEO:MMED) (OTCQB:MMEDF) is pursuing psychedelics inspired therapies to develop what it hopes will become the “antibiotic for addiction” at a time when the coronavirus (COVID-19) pandemic is putting tremendous stress on Americans struggling with addiction.
The New York City-based neuro-pharmaceutical company is making a run at curbing opioid abuse, based on 18-MC, a proprietary non-hallucinogenic molecule derivative of psychedelic ibogaine.
Ibogaine comes from iboga, a West African plant whose yellowish root bark induces powerful psychedelic experiences. It has its genesis in healing ceremonies among various African communities.
MindMed cofounder and co-CEO JR Rahn, a Silicon Valley entrepreneur, former Uber marketing employee and Y-Combinator alumnus, believes America was on track to face a mental health crisis before the coronavirus outbreak, and self-isolation, social distancing, and job losses are exacerbating the problem.
“I went through the Y-Combinator program from where companies like Airbnb and Dropbox developed and I was looking at my friends’ companies that were going to put a lot of people out of work,” Rahn told Proactive.
“Ultimately, what I saw was that addiction and mental health problems were going to skyrocket in America. These problems were already large, but they were going to get bigger in time. That’s all been fast forwarded now. COVID-19 and the lockdown in terms of isolation just made these problems bigger.”
According to a Blue Cross Blue Shield report, there’s an alarming rise in rates of depression, substance abuse, hyperactivity such as anxiety or attention deficit hyperactivity disorder (ADHD) creating something akin to a “health shock” among millennials.
Well-funded for clinical trails
To help in the fight against the "health shock", MindMed closed a $24.2 million funding round ahead of going public in March. Shark Tank’s Kevin O’Leary was one of the lead investors.
“If this can actually cure opioid addiction, that is a big, big opportunity,” O’Leary has told The Wall Street Journal. “Why wouldn’t I want a piece of that?”
With the strong investor backing, MindMed last year acquired a team developing 18-MC. Its lead researcher, Dr Stanley Glick, discovered 18-MC in the 1990s but struggled to find funding to test the drug on humans, even though animal trials showed promise for curing addiction. MindMed has now begun enrollment in further human safety studies of 18-MC, the company’s oral drug candidate for the treatment of opioid use disorders.
In extensive nonclinical testing, 18-MC has shown promise in helping to curb various forms of addiction. MindMed is scheduled to begin Phase 2 trials of 18-MC in opioid use disorder patients in late 2020.
In a statement, MindMed chief operating officer Carol Nast has said: “Our clinical and technical operations team have worked diligently to ensure everything is on schedule to further build the safety data package around 18-MC ahead of our studies in opioid use disorder patients.”
The clinical trials are on track despite the challenges posed by the coronavirus pandemic.
“Due to the global nature of drug development, we have built our company to function in a geographically distributed manner every day on Zoom. Because of this decision our work has continued uninterrupted and will pay dividends to our efficiency in the months ahead,” said Rahn.
Making LSD less trippy
Meanwhile, MindMed is also preparing a Phase II clinical trial in Europe to test how microdosing lysergic acid diethylamide (LSD) relates to increased focus for adults with attention deficit hyperactivity disorder (ADHD). Phase II trials test efficacy and safety. “We plan to build the largest portfolio of clinical trials for psychedelics,” declared Rahn.
In June, MindMed officially launched Project Lucy, a commercial drug development program for the treatment of anxiety disorders. The company said it intends to initiate a Phase 2b human efficacy trial that will focus on experiential doses of LSD administered by a therapist. MindMed noted that this is the first experiential, psychedelic-assisted therapy to be added to its drug development pipeline.
With the launch of Project Lucy, the company said it is now preparing a total of three Phase 2 commercial drug trials based on psychedelic-inspired medicines, making it one of the most advanced and largest drug development pipelines in the psychedelics industry.
"Having the first-mover advantage on a diverse pipeline of later-stage commercial drug trials in mental health is important for MindMed as a company, but the learnings we obtain from this pipeline also helps us push the frontier of psychedelic-inspired medicines," said Rahn.
As part of MindMed's decision to add an experiential therapy for anxiety disorders to its clinical development pipeline, the company has established a project task force that is preparing a briefing package for a potential Investigational New Drug (IND) with the US Food and Drug Administration (FDA).
MindMed said its Project Lucy task force is working to prepare and analyze data relevant for the discussion with the FDA relating to the potential opening of an IND for the treatment of anxiety disorders.
Many mental health disorders appear to be interconnected which presents a unique opportunity to MindMed to innovate and create a novel treatment paradigm. As an example, about 50% of attention deficit hyperactivity disorder (ADHD) patients also suffer from anxiety disorders. Furthermore, up to 90% of patients with General Anxiety Disorder also have symptoms of another mental health problem, such as depression or substance abuse.
The World Health Organization estimates that 284 million people are living with anxiety disorders globally and it is the most common mental illness in the US.
Contact the author Uttara Choudhury at [email protected]
Follow her on Twitter: @UttaraProactive