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.

John Hood [file photo]

UP­DATE: Cel­gene and the sci­en­tist who cham­pi­oned fe­dra­tinib's rise from Sanofi's R&D grave­yard win FDA OK

Six years after Sanofi gave it up for dead, the FDA has approved the myelofibrosis drug fedratinib, now owned by Celgene.

The drug will be sold as Inrebic, and will soon land in the portfolio at Bristol-Myers Squibb, which is finalizing a deal to acquire Celgene.

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UP­DAT­ED: AveX­is sci­en­tif­ic founder was axed — and No­var­tis names a new CSO in wake of an ethics scan­dal

Now at the center of a storm of controversy over its decision to keep its knowledge of manipulated data hidden from regulators during an FDA review, Novartis CEO Vas Narasimhan has found a longtime veteran in the ranks to head the scientific work underway at AveXis, where the incident occurred. And the scientific founder has hit the exit.

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Ab­b­Vie gets its FDA OK for JAK in­hibitor upadac­i­tinib, but don’t look for this one to hit ex­ecs’ lofty ex­pec­ta­tions

Another big drug approval came through on Friday afternoon as the FDA OK’d AbbVie’s upadacitinib — an oral JAK1 inhibitor that is hitting the rheumatoid arthritis market with a black box warning of serious malignancies, infections and thrombosis reflecting fears associated with the class.

It will be sold as Rinvoq — at a wholesale price of $59,000 a year — and will likely soon face competition from a drug that AbbVie once controlled, and spurned. Reuters reports that a 4-week supply of Humira, by comparison, is $5,174, adding up to about $67,000 a year.

The top 10 fran­chise drugs in bio­phar­ma his­to­ry will earn a to­tal of $1.4T (tril­lion) by 2024 — what does that tell us?

Just in case you were looking for more evidence of just how important Amgen’s patent win on Enbrel is for the company and its investors, EvaluatePharma has come up with a forward-looking consensus estimate on what the list of top 10 drugs will look like in 2024.

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ICER blasts FDA, PTC and Sarep­ta for high prices on DMD drugs Em­flaza, Ex­ondys 51

ICER has some strong words for PTC, Sarepta and the FDA as the US drug price watchdog concludes that as currently priced, their respective new treatments for Duchenne muscular dystrophy are decidedly not cost-effective.

The final report — which cements the conclusions of a draft issued in May — incorporates the opinion of a panel of 17 experts ICER convened in a public meeting last month. It also based its analysis of Emflaza (deflazacort) and Exondys 51 (eteplirsen) on updated annual costs of $81,400 and over $1 million, respectively, after citing “incorrect” lower numbers in the initial calculations.

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There’s nothing quite like a big patent win when it comes to burnishing your prospects in the pipeline. And for Amgen, which seems to have rescued Enbrel for a run to 2029, the cheering section on Wall Street is now fixed on AMG 510 and a key rival.

And it didn’t take much data to do it. 

There was the first snapshot of a handful of patients, with a 50% response rate. Then came word that Amgen researchers are also tracking responses in different cancers, at least one in colorectal cancer and appendiceal too. 

Bain's Or­ly Mis­han joins Pfiz­er's neu­ro spin­out Cerev­el; On­colyt­ic virus biotech taps Sil­la­Jen ex­ec He­le­na Chaye as CEO

→ Bain Capital is deploying one of its top investors to Cerevel Therapeutics, steering a $350 million-plus neuro play carved out of Pfizer. Orly Mishan — a co-founder and principal of Bain’s life sciences unit — was involved in the partnership that birthed the biotech spinout in the first place. As Cerevel’s first chief business officer, she is tasked with corporate development, program management as well as technical operations. 

UP­DAT­ED: Sci­en­tist-CEO ac­cused of im­prop­er­ly us­ing con­fi­den­tial in­fo from uni­corn Alec­tor

The executive team at Alector $ALEC has a bone to pick with scientific co-founder Asa Abeliovich. Their latest quarterly rundown has this brief note buried inside:

On June 18, 2019, we initiated a confidential arbitration proceeding against Dr. Asa Abeliovich, our former consulting co-founder, related to alleged breaches of his consulting agreement and the improper use of our confidential information that he learned during the course of rendering services to us as our consulting Chief Scientific Officer/Chief Innovation Officer. We are in the early stage of this arbitration proceeding and are unable to assess or provide any assurances regarding its possible outcome.

There’s no explicit word in the filing on what kind of confidential info was involved, but the proceeding got started 2 days ahead of Abeliovich’s IPO.

Abeliovich, formerly a tenured associate professor at Columbia, is a top scientist in the field of neurodegeneration, which is where Alector is targeted. More recently, he’s also helped start up Prevail Therapeutics as the CEO, which raised $125 million in an IPO. And there he’s planning on working on new gene therapies that target genetically defined subpopulations of Parkinson’s disease. Followup programs target Gaucher disease, frontotemporal dementia and synucleinopathies.

But this time Abeliovich is the CEO rather than a founding scientist. And some of their pipeline overlaps with Alector’s.

Abeliovich and Prevail, though, aren’t taking this one lying down.

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Chi­na has be­come a CEO-lev­el pri­or­i­ty for multi­na­tion­al phar­ma­ceu­ti­cal com­pa­nies: the trend and the im­pli­ca­tions

After a “hot” period of rapid growth between 2009 and 2012, and a relatively “cooler” period of slower growth from 2013 to 2015, China has once again become a top-of-mind priority for the CEOs of most large, multinational pharmaceutical companies.

At the International Pharma Forum, hosted in March in Beijing by the R&D Based Pharmaceutical Association Committee (RDPAC) and the Pharmaceutical Research and Manufacturers of America (PhRMA), no fewer than seven CEOs of major multinational pharmaceutical firms participated, including GSK, Eli Lilly, LEO Pharma, Merck KGaA, Pfizer, Sanofi and UCB. A few days earlier, the CEOs of several other large multinationals attended the China Development Forum, an annual business forum hosted by the research arm of China’s State Council. It’s hard to imagine any other country, except the US, having such drawing power at CEO level.