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Tuesday, 05/11/2021 1:05:59 PM

Tuesday, May 11, 2021 1:05:59 PM

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I'd say this article in Barron's is a ray of sunshine for investors interested in MINE.

The First Phase 3 Success for Psychedelics Will Pave the Way for an Industry
By Bill Alpert
May 11, 2021 8:00 am ET
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Post-traumatic stress disorder is a crippling, hard-to-treat psychiatric affliction. America spends billions of dollars yearly just on the veterans who suffer from PTSD. So it’s heartening to see the report of a promising new treatment, published Monday in Nature Medicine.

As the first Phase 3 trial of a psychedelic drug, the study is also at the forefront of a wave of excitement among therapists and investors in the healing potential of historically-outlawed substances like cannabis, psilocybin mushrooms, ibogaine and ayahuasca.

In Monday’s report, an international team of researchers describe their test of a treatment combining psychotherapy with doses of MDMA—the illegal drug popularly known as Ecstasy or Molly. The MDMA-assisted therapy was dramatically effective at reducing PTSD symptoms and improving daily functioning in the 42 treated participants, when compared with the 37 participants who got psychotherapy and a placebo drug.

Two months after their last drug-assisted session, two-thirds of the MDMA-treated patients no longer met the diagnosis for PTSD, compared with one third of those treated with placebos. While clearly significant in the patients’ lives, the difference was also highly statistically-significant.

The news lifted the stocks of most psychedelic drug development companies, even though they weren’t involved in the MDMA study—which was sponsored by a nonprofit organization. Shares of Compass Pathways (ticker: CMPS) rose 5% Monday, to $35.77, as the Nasdaq Composite dropped 2.6%. Field Trip Health (FTRPF) gained 13%, to $5.18. Mind Medicine (MNMD) slipped 6%, to $3. Awaiting effectiveness of its initial offering prospectus is Atai Life Sciences, a Berlin-based psychedelics enterprise that aims to raise more than $100 million in its Nasdaq IPO.

The MDMA study recruited 90 PTSD patients in the U.S., Canada and Israel. Their average age was 41 and had been diagnosed with PTSD for an average of 15 years. Over 90% also suffered from depression and had wrestled with suicidal urges. While PTSD is popularly-associated with war veterans, it’s more commonly found in women, and two-thirds of the study participants were female.

Treatment involved three preparatory psychotherapy sessions with a two-therapist team. Then the study participants had three eight-hour therapy sessions, after doses of either MDMA or a placebo. Psychotherapy continued after the drug-assisted sessions. The study was double-blinded, with outside raters measuring changes in the participants’ PTSD symptoms and daily functioning.

The U.S. Food and Drug Administration has approved only a couple of antidepressants as treatments for PTSD, and about half of PTSD patients get no relief from those drugs. But in the MDMA-assisted study, 67% of treated patients improved enough to no longer satisfy the diagnostic criteria for the condition, while a third enjoyed complete remissions after the three drug-assisted sessions. In its prescribed use, the MDMA caused no major safety issues.

The Nature authors speculate that MDMA-assisted sessions produce a “window of tolerance,” in which patients are able to revisit traumatic memories, with less shame and anger, and without being overwhelmed by PTSD symptoms. The treatment worked equally well for patients with histories of drug and alcohol abuse.

“When people see these results, there will be tremendous interest in it,” said Amy Emerson, the chief executive of the MDMA study’s overseer, the MAPS Public Benefit Corporation, told Barron’s. The unusual enterprise grew out of the three-decade effort of a nonprofit group called the Multidisciplinary Association of Psychedelic Studies (or MAPS), to overcome the medical and legal obstacles to scientific study of banned psychoactive drugs.

MAPS was founded by Rick Doblin in 1986, not long after the federal government banned Ecstasy. In the years that followed he stubbornly pulled together the millions of dollars in donations, and dozens of researchers and lawyers, needed to bring MDMA-assisted therapy to the Phase 3 finish line. “We’re the oldest start-up in the world,” Doblin joked to Barron’s.