Before the end of the year, clinical results also are expected from a study involving Compass Pathways — which became a publicly traded company late last year — using its approach of guided psilocybin experiences as a treatment for drug-resistant depression."People still believe that 'your brain on drugs' commercial is the truth rather than all scientific evidence on major therapeutic benefits," said Simon, who heads the Psychedelic Medicines for Mental Health Group at entrepreneurial network YPO and serves on an advisory council at Mass General Hospital on the topic.There are examples of stigmatized drugs in FDA-approved medical usage, including ketamine as an anesthesia since the 1970s and ultimately used on an "off-label" basis to treat depression based on the existing FDA authorization.
In 2019, a Johnson & Johnson ketamine-derived treatment for drug-resistant depression was the first new approach for the mental health condition specifically approved by the FDA in decades.The current treatment approach of helping people to live with depression and PTSD, and on medication, creates a patient population and cost factor that is a burden on the health-care system."Covid has done a lot of terrible things, but it has elevated mental health visibility, and as a result of that there is lots of interest," Simon said.One of the biggest investors in the emerging field is Atai Life Sciences, a holding company for multiple biotech start-ups pursuing alternative treatments for depression, anxiety and addiction based on stigmatized drugs.A common thread among those closely watching, and investing in this space, is the personal experience with family and friends suffering from mental illness and struggling to find a successful medical treatment.
"These people have been suffering for decades," said Roth Capital's Piros, who has a family member struggling with depression.
Still, Piros said that the proper way to think about this new theme is as part of an existing investment risk tolerance for the biotech sector, and these new drugs should be no more than 10% of that existing allocation.
if we only need treatment for depression twice a year to be in remission that is a thousand times better than anything we can offer today, and PTSD has no approved drug," Piros said.If a company like Compass makes it to market, its treatment approach could reach millions of Americans — estimates range from roughly 2 million to 4 million — not being served well by the current class of depression drugs.
Pricing of the treatment could be $10,000, according to Cowen estimates, or as high as $20,000, according to Piros, which he said is closer to the cost of current treatments.
Piros said he has discussed alternative treatments with psychiatrists on behalf of his family, but they told him they would not be interested until there are decades of placebo-controlled trial data behind the drugs.
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