Mag­ic mush­rooms might treat de­pres­sion? Pe­ter Thiel-backed Com­pass gets FDA OK to launch Phase IIb tri­als

For years now, psy­che­del­ic sci­en­tists have been telling us that trip­ping on mag­ic mush­rooms might “re­boot” the brain, clear­ing out neg­a­tive thought net­works that might con­tribute to de­pres­sion. Now, it looks like the FDA is will­ing to test the the­o­ry.

Com­pass of­fi­cial­ly got the OK from US reg­u­la­tors to see how pa­tients with de­pres­sion re­spond to psilo­cy­bin — the ac­tive in­gre­di­ent in hal­lu­cino­genic mush­rooms. They’re launch­ing a Phase IIb dose-rang­ing study with 216 pa­tients. The ther­a­py be­ing test­ed in­cludes the drug it­self along with psy­cho­log­i­cal sup­port. They’ve shown promise when com­bined, Com­pass says.

The idea here is that psilo­cy­bin can “re­boot” or “de­frag” a pa­tient’s brain. Fol­low­ing a psy­che­del­ic trip, there’s an ini­tial dis­in­te­gra­tion of brain net­works fol­lowed by a re-in­te­gra­tion af­ter­wards. How psilo­cy­bin might treat de­pres­sion is com­plex, but in essence it seems to be tied to a pa­tient’s per­cep­tion. In lay­man’s terms, the drug ap­pears to briefly dis­able the part of the brain where “the self” talks to it­self, per­haps dis­rupt­ing neg­a­tive or de­struc­tive thought pat­terns.

A num­ber of small aca­d­e­m­ic stud­ies have sug­gest­ed that psilo­cy­bin ther­a­py can of­fer both im­me­di­ate and sus­tained re­duc­tions in de­pres­sion fol­low­ing a sin­gle treat­ment. Com­pass has a list of rel­e­vant stud­ies on its web­site. Aca­d­e­mics in the space say more re­search must be done to un­der­stand what ex­act­ly is hap­pen­ing in the brain dur­ing this process.

David Nutt

David Nutt, the for­mer chief drug ad­vi­sor for the British gov­ern­ment and a cur­rent sci­en­tif­ic ad­vi­sor to Com­pass Path­ways, says cul­tur­al snob­bery and bur­den­some reg­u­la­tions have ham­pered re­search in the field of psy­che­delics for too long.

Stud­ies con­duct­ed on psilo­cy­bin and LSD in the 50s and 60s showed sig­nif­i­cant ben­e­fits in a range of dis­or­ders, such as al­co­holism and de­pres­sion,” he wrote in a re­cent Metro piece. “Be­fore 1967, the US gov­ern­ment had fund­ed 140 stud­ies on the ther­a­peu­tic val­ue of psy­che­delics, as de­scribed by Dr. Robert Mas­ters and Dr. Jean Hous­ton… But once these psy­che­delics be­came a part of mu­sic and youth cul­ture, they were banned and re­search stopped, with lit­tle if any con­sid­er­a­tion for pa­tients.”

Pe­ter Thiel

Found­ed in 2016 — and backed ear­ly on by high-pro­file Sil­i­con Val­ley in­vestor Pe­ter Thiel (who’s known for mak­ing in­vest­ments in con­tro­ver­sial star­tups) — Com­pass isn’t alone in look­ing to psy­che­delics to treat de­pres­sion. In fact, there’s been a re­cent resur­gence in the study of drugs like mush­rooms and LSD for men­tal ill­ness. Us­ing psilo­cy­bin to treat de­pres­sion is even the top­ic of pop­u­lar main­stream au­thor Michael Pol­lan’s new book: How to Change Your Mind.

Com­pass’ lat­est tri­al will be­gin in the Unit­ed King­dom lat­er this month. Sites in oth­er coun­tries will join as fur­ther reg­u­la­to­ry ap­provals are re­ceived. The UK, Cana­da, and the Nether­lands have al­ready giv­en a thumbs up to start the tri­al.

The Avance Clinical leadership team: CEO Yvonne Lungershausen, Sandrien Louwaars - Director Business Development Operations, Gabriel Kremmidiotis - Chief Scientific Officer, Ben Edwards - Chief Strategy Officer

How Aus­tralia De­liv­ers Rapid Start-up and 43.5% Re­bate for Ear­ly Phase On­col­o­gy Tri­als

About Avance Clinical

Avance Clinical is an Australian owned Contract Research Organisation that has been providing high-quality clinical research services to the local and international drug development industry for 20 years. They specialise in working with biotech companies to execute Phase 1 and Phase 2 clinical trials to deliver high-quality outcomes fit for global regulatory standards.

As oncology sponsors look internationally to speed-up trials after unprecedented COVID-19 suspensions and delays, Australia, which has led the world in minimizing the pandemic’s impact, stands out as an attractive destination for early phase trials. This in combination with the streamlined regulatory system and the financial benefits including a very favourable exchange rate and the R & D cash rebate makes Australia the perfect location for accelerating biotech clinical programs.

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Paul Hudson, Sanofi CEO (Getty Images)

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