The 'mind-blow­ing' R&D re­nais­sance in psy­che­del­ic meds finds a home at Johns Hop­kins

The “mind-blow­ing” field of psy­che­del­ic re­search is get­ting its first ma­jor US home, one that could help le­git­imize a field that has slow­ly crept out of the shad­ows over the last two decades.

Johns Hop­kins Med­i­cine an­nounced Wednes­day they are open­ing what they be­lieve to be the first cen­ter for psy­che­del­ic re­search in the coun­try and the largest in the world.

The Cen­ter for Psy­che­del­ic and Con­scious­ness Re­search at Johns Hop­kins Med­i­cine will in­clude a team of 11 fac­ul­ty sci­en­tists and post-docs in­ves­ti­gat­ing the po­ten­tial use of LSD and psilo­cy­bin (the chem­i­cal found in mag­ic mush­rooms) — among oth­er psy­che­delics — to im­pact hu­man cre­ativ­i­ty and well-be­ing and to treat a host of dis­or­ders, in­clud­ing opi­oid ad­dic­tion, Alzheimer’s dis­ease and PTSD.

Once stud­ied ex­ten­sive­ly by the fed­er­al gov­ern­ment, psy­che­delics vir­tu­al­ly dis­ap­peared from re­search lab­o­ra­to­ries af­ter most were sched­uled as Class I drugs by the Nixon Ad­min­is­tra­tion in 1970. But since 2000, when Johns Hop­kins ob­tained ap­proval to ad­min­is­ter psy­che­delics to hu­man sub­jects who had nev­er tak­en one be­fore, sci­en­tists at a hand­ful of in­sti­tu­tions have steadi­ly brought the cat­e­go­ry of drugs in­to the sci­en­tif­ic fore­ground.

These re­searchers have de­scribed some of their re­sults as “mind-blow­ing” in their abil­i­ty to help pa­tients, as health writer Michael Pol­lan re­port­ed in the New York­er in 2015. Pol­lan has been one of the most promi­nent pro­mot­ers of psy­che­delics, writ­ing in pop­u­lar pub­li­ca­tions and his new book How to Change Your Mind about the po­ten­tial for this class of drugs to treat anx­i­ety and de­pres­sion with hereto­fore un­heard-of suc­cess.

In March, the FDA ap­proved a psy­che­del­ic drug for the first time: Es­ke­t­a­mine for treat­ing de­pres­sion. MD­MA (com­mon­ly called ec­sta­sy) re­ceived break­through ther­a­py sta­tus in 2017 and Phase III tri­als to use it as PTSD treat­ment have shown promise. Tri­als com­plet­ed at NYU and Hop­kins – which prompt­ed the “mind-blow­ing” de­scrip­tion – high­light­ed the po­ten­tial for the drugs to de­crease “ex­is­ten­tial dis­tress” in can­cer pa­tients.

Nev­er­the­less, sig­nif­i­cant le­gal hur­dles ex­ist to ob­tain­ing gov­ern­ment funds for psy­che­del­ic re­search and the cen­ter will be en­tire­ly pri­vate­ly fund­ed. The list of donors, though, re­flects the rep­u­ta­tion and cache the drugs have amassed among a younger gen­er­a­tion of in­flu­encers and Sil­i­con Val­ley types, who have dri­ven some of the de­vel­op­ment to date. They in­clude au­thor, tech in­vestor, and pod­cast host Tim Fer­riss, Word­Press co-founder Matt Mul­len­weg and TOMS founder Blake My­coskie.

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In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

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Uğur Şahin, BioNTech CEO (Kay Nietfeld/picture-alliance/dpa/AP Images)

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The German biotech reported over $3.2 billion in revenue in Q2 on Monday, down from more than $6.7 billion in Q1, in part due to falling Covid sales. While management said last quarter that they anticipated a Covid sales drop — CEO Uğur Şahin said at the time that “the pandemic situation is still very much uncertain” — Q2 sales still missed consensus by 14%.

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David Reese, Amgen R&D chief

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Anna Protopapas, Mersana CEO

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AstraZeneca and Daiichi Sankyo made waves with their nearly $7 billion collaboration back in spring 2019, but at that point, Enhertu was already nearing the FDA’s doors with clinical data. The latest ADC tie-up to enter the biopharma fray centers around a preclinical asset, Mersana Therapeutics’ XMT-2056.

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Just ahead of the weekend, word got out that Pfizer was close to clinching a $5 billion buyout — albeit with other potential buyers still at the table. The pharma giant, flush with cash from Covid-19 vaccine sales, apparently got out on top.

The deal immediately swells Pfizer’s previously tiny sickle cell disease portfolio from just a Phase I program to one with an approved drug, Oxbryta, plus a whole pipeline that, if all approved, the company believes could make for a $3 billion franchise at peak.

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Pascal Soriot, AstraZeneca CEO (David Zorrakino/Europa Press via AP Images)

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The partners pulled a win on Friday in HER2-low breast cancer patients who’ve already failed on chemotherapy, just two weeks after submitting a supplemental BLA. While this isn’t the FDA’s fastest approval — Bristol Myers Squibb won an OK for its blockbuster checkpoint inhibitor Opdivo in just five days back in March — it comes well ahead of Enhertu’s original Q4 PDUFA date.

FDA commissioner Rob Califf (Tom Williams/CQ Roll Call via AP Images)

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Throughout the Covid-19 pandemic, the issue of vaccine uptake has been a point of contention, but a new platform from GSK and IQVIA is hoping to shed more light on vaccine data, via new transparency and general awareness.

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Steve Paul, Karuna Therapeutics CEO (Third Rock)

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An investigational pill that combines a former Eli Lilly CNS compound with an overactive bladder drug was better than placebo at reducing a scale of symptoms experienced by patients with schizophrenia in a Phase III trial.

Karuna Therapeutics’ drug passed the primary goal in EMERGENT-2, the Boston biotech said early Monday morning, alongside quarterly earnings. The study is the first of Karuna’s four Phase III clinical trials to read out in schizophrenia and will provide the backbone to the biotech’s first drug approval application, slated for mid-2023.

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