Psy­che­del­ic drug re­search breaks out of deep freeze as re­searchers head for the clin­ic with am­bi­tious tri­al plans

David Nichols en­tered grad­u­ate school in 1969 with dreams of crack­ing LSD. He was a child of the 60s, his friends drop­ping tabs and go­ing on about the vi­sions they saw – the big bang, god, in­fin­i­ty pro­ject­ed – and how it changed them in ways on­ly ma­jor life events could. Nichols was go­ing to fig­ure out how it all worked.

David Nichols Pur­due

And then in 1970, Con­gress passed the Con­trolled Sub­stance Act. LSD, which the gov­ern­ment had stud­ied ex­ten­sive­ly for two decades, be­came a Sched­ule I drug. The dol­lars washed up. For 30 years, psy­che­delics be­came all but un­touch­able for clin­i­cal tri­als.

“The Con­trolled Sub­stances Act was passed, and I thought, ‘Oh, well there goes that [idea],” Nichols told End­point News.

Now half a cen­tu­ry lat­er, Johns Hop­kins Med­i­cine is open­ing up the na­tion’s first ma­jor cen­ter for psy­che­del­ic re­search, a $17 mil­lion, pri­vate­ly-backed bet that re­flects a 20-year-long sea change in how psy­che­del­ic re­search is viewed by clin­i­cians and the promise the drugs have shown in treat­ing a host of psy­chi­atric dis­or­ders. The Cen­ter for Psy­che­del­ic and Con­scious­ness Re­search at Johns Hop­kins Med­i­cine will al­so ex­plore the drugs’ im­pact on cre­ativ­i­ty and well-be­ing.

“Oh, it’s huge,” says Nichols, who as a pro­fes­sor at Pur­due Uni­ver­si­ty be­came one of the on­ly psy­che­del­ic re­searchers (he fo­cused on an­i­mals) and one of the top ad­vo­cates for re­open­ing clin­i­cal tri­als dur­ing the three-plus decades the drugs were al­most en­tire­ly mar­gin­al­ized. “Where mon­ey has been the ob­sta­cle, now mon­ey is no longer the prob­lem.”

Af­ter years in the side­lines, psy­che­delics  be­gan­to creep back in­to the phar­ma­ceu­ti­cal imag­i­na­tion in 2000, when Johns Hop­kins ob­tained ap­proval to ad­min­is­ter psy­che­delics to healthy hu­man sub­jects.

Sci­en­tists at a hand­ful of promi­nent in­sti­tu­tions have since en­tered the field, con­duct­ing tri­als on how psy­che­delics can treat long-in­tractable dis­or­ders – some­times with dra­mat­ic suc­cess: psilo­cy­bin (the chem­i­cal found in mag­ic mush­rooms) for ad­dic­tion and a slew of ail­ments, LSD for de­pres­sion, MD­MA for PTSD.

Ear­ly re­sults have ap­peared as a panacea to psy­chi­atric pa­tients who have gone years on SS­RIs and oth­er treat­ments with­out sig­nif­i­cant im­prove­ment and opened the door to a string of star­tups seek­ing to ad­vance and cap­i­tal­ize on the emerg­ing mar­ket. Re­searchers tout­ed the re­sults of one pair of NYU and Hop­kins stud­ies on psilo­cy­bin to treat “ex­is­ten­tial dread” in can­cer pa­tients as “mind-blow­ing,”

“I think we’re look­ing at a par­a­digm shift,” says Nichols, who found­ed the Heffter Re­search In­sti­tute in 1993 to ad­vo­cate for and even­tu­al­ly fund clin­i­cal tri­als. “I think it’ll be a rev­o­lu­tion­ary change for peo­ple who suf­fer from these dis­or­ders. We didn’t have any­thing that worked un­til now.”

Re­searchers char­ac­ter­ized the cen­ter as a sign of how main­stream the field has be­come and an an­nounce­ment that will on­ly le­git­imize it fur­ther.

But im­me­di­ate­ly, the mon­ey will fu­el sev­er­al clin­i­cal tri­als at Hop­kins – in­clud­ing those for opi­oid ad­dic­tion, Alzheimer’s dis­ease, PTSD and co-oc­cur­ring mood and al­co­hol prob­lems – equip­ping sci­en­tists with funds that re­main scarce for psy­che­del­ic re­search.

Al­most all psy­che­delics are still Sched­ule I drugs, mean­ing of­fi­cial­ly they have “no cur­rent­ly ac­cept­ed med­ical use” and the NIH will not fund stud­ies on them. The prob­lem has plagued the field since its resur­gence.

Al­bert Gar­cia Johns Hop­kins

“Usu­al­ly sci­ence is a lot of beg­ging for mon­ey,” Al­bert Gar­cia, who will lead the Hop­kins Alzheimer’s study, told End­points News, “and this means we won’t have to do that for a cou­ple years at least.”

The fu­ture be­yond clin­i­cal tri­als re­mains murky, though, and the ex­u­ber­ance of some re­searchers and ad­vo­cates has led to push­back by crit­ics of the sci­ence (psy­che­del­ic stud­ies are nec­es­sar­i­ly not dou­ble-blind) and those, in­clud­ing health writer and pro­po­nent of psy­che­del­ic re­search Michael Pol­lan, who say ad­vo­cates for mag­ic mush­room de­crim­i­nal­iza­tion send a mes­sage that the drugs are not dan­ger­ous.

“This is not some sort of mag­ic bul­let that will be solv­ing all these men­tal health prob­lems,” Gar­cia said.

In March, the FDA ap­proved its first psy­che­del­ic drug: Es­ke­t­a­mine for treat­ing de­pres­sion. And in 2017 and 2018, the agency grant­ed break­through sta­tus to an MD­MA pro­to­col for treat­ing PTSD and to UK start­up Com­pass Path­ways’ psilo­cy­bin pro­to­col for treat­ing de­pres­sion. But there’s been lit­tle in­di­ca­tion of change to the un­der­ly­ing fed­er­al law.

Sim­i­lar ques­tions re­main about pre­cise­ly how these drugs would come to mar­ket, es­pe­cial­ly as the field has caught the eye of in­vestors in Sil­i­con Val­ley and Eu­rope. The list of Hop­kins donors in­cludes TOMS founder Blake My­coskie and pop­u­lar en­tre­pre­neur Tim Fer­riss but oth­er in­vestors have fun­neled mon­ey in­to pri­vate, for-prof­it ven­tures like Com­pass and ATAI.

In­g­mar Gor­man

“Scal­ing and ac­ces­si­bil­i­ty of treat­ments are ques­tions on every­one’s mind at the mo­ment,” In­g­mar Gor­man, di­rec­tor of the Psy­che­del­ic Ed­u­ca­tion and Con­tin­u­ing Care Pro­gram at the Cen­ter for Op­ti­mal Liv­ing and co-prin­ci­pal in­ves­ti­ga­tor on a stage III MD­MA study for treat­ing PTSD, told End­points News in an email.

Psy­che­delics such as psilo­cy­bin won’t op­er­ate on the pill-a-day for­mu­la that dom­i­nates most cur­rent psy­chi­atrics. Rather, a pa­tient would go in a few times per year to re­ceive dos­es in a con­trolled en­vi­ron­ment with med­ical pro­fes­sion­als. It’s un­clear yet what the costs would be, though Nichols and oth­ers are op­ti­mistic wide­spread knowl­edge of how to man­u­fac­ture psilo­cy­bin, for in­stance, will make it dif­fi­cult to patent and keep prices down.

Eka­te­ri­na Malievska­ia Com­pass

Last year, Com­pass Path­ways made head­lines af­ter in­sid­ers ac­cused them in Quartz of try­ing to form a mo­nop­oly on the glob­al sup­ply of psilo­cy­bin. They de­nied the charges but said se­cur­ing a large sup­ply was es­sen­tial to their busi­ness mod­el of in­te­grat­ing their ther­a­pies sys­tems.

They told End­points they weren’t a psy­che­del­ic com­pa­ny, but sim­ply look­ing for the best ways to tack­le men­tal health prob­lems.

“Right now, I don’t see any­thing more promis­ing than re­search in psy­che­delics,” says CIO and co-founder Eka­te­ri­na Malievska­ia. “But things can change.”

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

The End­points 11: They've got mad mon­ey and huge am­bi­tions. It's time to go big or go home

These days, selecting a group of private biotechs for the Endpoints 11 spotlight begins with a sprint to get ahead of IPOs and the M&A teams at Big Pharma. I’ve had a couple of faceplants earlier this year, watching some of the biotechs on my short list choose a quick leap onto Nasdaq or into the arms of a buyer.

Vividion, you would have been a great pick for the Endpoints 11. I’m sorry I missed you.

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Dave Lennon, former president of Novartis Gene Therapies

So what hap­pened with No­var­tis Gene Ther­a­pies? Here's your an­swer

Over the last couple of days it’s become clear that the gene therapy division at Novartis has quietly undergone a major reorganization. We learned on Monday that Dave Lennon, who had pursued a high-profile role as president of the unit with 1,500 people, had left the pharma giant to take over as CEO of a startup.

Like a lot of the majors, Novartis is an open highway for head hunters, or anyone looking to staff a startup. So that was news but not completely unexpected.

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Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

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First, Pfizer applied for approval of a supplemental application for the booster shots, but since last Friday’s adcomm reviewing them, the plan has devolved into an EUA, which the FDA issued late Thursday evening.

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Of the more than 30,000 enrolled in the trial that ultimately led to the vaccine’s EUA, only two people in the vaccine group got a severe form of the disease, compared to 106 in the placebo group — leading to an efficacy of 98%.

Emma Walmsley, GlaxoSmithKline CEO (Credit: Fang Zhe/Xinhua/Alamy Live News)

The fire un­der Glax­o­SmithK­line's Em­ma Walm­s­ley grows as an­oth­er well-known ac­tivist in­vestor grabs its pitch­fork — re­port

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The London-based hedge fund joins another notorious activist firm in Paul Singer’s Elliott Management, which earlier this year called for a shakeup in leadership at GSK to handle what the company described as a wealth of riches across the drug giant’s portfolio hindered by limited vision from top staff.

FDA+ roundup: Bs­U­FA III ready for show­time, court tells FDA to re-work com­pound­ing plan, new guid­ance up­dates and more

The FDA has now spelled out what exactly will be included in the third iteration of Biosimilar User Fee Act (BsUFA) from 2023 through 2027, which similarly to the prescription drug deal, sets fees that industry has to pay for submitting applications, in exchange for firm timelines that the agency must meet.

This latest deal includes several sweeteners for the biosimilar industry, which has yet to make great strides in the US market, with shorter review timelines for safety labeling updates and updates to add or remove an indication that does not contain efficacy data.

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Joshua Liang, Clover Biopharmaceuticals CEO

With world still in sore need of dos­es, Clover says its Covid-19 vac­cine is 67% ef­fec­tive in Phase III

With concerns about the Delta variant rising and much of the world still in desperate need of vaccine doses, a Chinese biotech announced Wednesday that a new shot has shown positive results in a large trial against Covid-19, including new variants.

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