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.”

Once fu­ri­ous over No­var­tis’ da­ta ma­nip­u­la­tion scan­dal, the FDA now says it’s noth­ing they need to take ac­tion on

Back in the BP era — Before Pandemic — the FDA ripped Novartis for its decision to keep the agency in the dark about manipulated data used in its application for Zolgensma while its marketing application for the gene therapy was under review.

Civil and criminal sanctions were being discussed, the agency noted in a rare broadside at one of the world’s largest pharma companies. Notable lawmakers cheered the angry regulators on, urging the FDA to make an example of Novartis, which fielded Zolgensma at $2.1 million — the current record for a one-off therapy.

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Covid-19 roundup: GSK, Am­gen tai­lor R&D work to fit the coro­n­avirus age; Doud­na's ge­nomics crew launch­es di­ag­nos­tic lab

You can add Amgen and GSK to the list of deep-pocket drug R&D players who are tailoring their pipeline work to fit a new age of coronavirus.

Following in the footsteps of a lineup of big players like Eli Lilly — which has suspended patient recruitment for drug studies — Amgen and GSK have opted to take a more tailored approach. Amgen is intent on circling the wagons around key studies that are already fully enrolled, and GSK has the red light on new studies while the pandemic plays out.

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In a stun­ning set­back, Amarin los­es big patent fight over Vas­cepa IP. And its high-fly­ing stock crash­es to earth

Amarin’s shares $AMRN were blitzed Monday evening, losing billions in value as reports spread that the company had lost its high-profile effort to keep its Vascepa patents protected from generic drugmakers.

Amarin had been fighting to keep key patents under lock and key — and away from generic rivals — for another 10 years, but District Court Judge Miranda Du in Las Vegas ruled against the biotech. She ruled that:
(A)ll the Asserted Claims are invalid as obvious under 35 U.S.C.§ 103. Thus, the Court finds in favor of Defendants on Plaintiff’s remaining infringementclaim, and in their favor on their counterclaims asserting the invalidity of the AssertedClaims under 35 U.S.C. § 103.

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It is 'kind of a proven tech­nol­o­gy': Hep B vac­cine mak­er joins glob­al hunt for coro­n­avirus vac­cine

Using lab-grown proteins that are engineered to mimic the architecture of viruses to induce an immune response, VBI Vaccines is joining the hunt for a coronavirus vaccine — harnessing technology that has initially been proved safe in early trials as a prophylactic for cytomegalovirus (CMV) infection.

Unlike the raft of the companies in the Covid-19 vaccine race — including Moderna, CureVac and J&J — VBI is taking a pan-coronavirus approach, by developing a vaccine that will encompass Covid-19, severe acute respiratory syndrome (SARS), and Middle East respiratory syndrome (MERS).

Covid-19 roundup: J&J, BAR­DA set ear­ly 2021 fin­ish line for $1B vac­cine race; FDA al­lows emer­gency drug use, ahead of piv­otal da­ta

J&J has zeroed in on a Covid-19 vaccine candidate that it hopes to begin testing in humans by September this year — with the extraordinary goal of getting it ready for emergency use in early 2021. And together with BARDA, it’s committing $1 billion to make it happen.

That kind of accelerated timeline would fall on the fast side of NIAID director Anthony Fauci’s well-publicized prediction that it would be another 12 to 18 months before a vaccine can be available for public use. A Phase I trial of Moderna’s mRNA vaccine began two weeks ago, and both the biotech and fellow mRNA player CureVac have discussed similar, if not even faster, timelines for emergency use among healthcare workers.

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As­traZeneca says its block­buster Farx­i­ga proved to be a game-chang­er in CKD — wrap­ping PhI­II ear­ly

If the FDA can still hold up its end of the bargain, AstraZeneca is already on a short path to scooping up a cutting-edge win with a likely approval for their SGLT2 drug Farxiga in cutting the risk of heart failure. Now the pharma giant says it can point to solid evidence that the drug — initially restricted to diabetes — also works for chronic kidney disease, potentially adding a blockbuster indication for the franchise.

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Can a pair of top AveX­is alum­ni steer a new gene ther­a­py up­start to R&D glo­ry? 3 VCs bet $60M on it

VCs love few things more than a proven executive team when it comes to launching a new company. And now a group of A-listers has turned to a pair of top execs out of AveXis to steer the latest gene therapy player into the clinic.

The biotech is Waltham, MA-based Affinia and the two execs are Sean Nolan and Rick Modi — the former CEO and CBO respectively of AveXis, the gene therapy pioneer that fetched $8.7 billion in a sale to Novartis. Nolan has now taken the chairman’s role at Affinia while Modi moves up to the CEO post at the company.

Un­de­terred by a pan­dem­ic, Gilde Health­care rais­es their largest fund yet

When Pieter van der Meer started raising the capital for Gilde Healthcare’s fifth fund in the waning months of 2019, he had his eyes on a different chain of events that could change the healthcare system and perhaps even play to his firm’s advantage: The US presidential election.

Since raising their third fund in 2011, the 34-year-old Dutch firm had focused on value-based care. They chose late-stage biotechs that came up with new devices and delivery systems for de-risked established compounds, and when they chose preclinical biotechs, they spoke with potential pharma partners, payers and regulators to ask where and at what prices the drug made sense. As the Democratic primary became a contest over how to lower healthcare costs, it looked like a strategy that could pay off.

Just in time to as­sure a de­ci­sion be­fore CVR dead­line, Bris­tol My­ers Squibb files NDA for Cel­gene/blue­bird CAR-T

A new CAR-T therapy may be coming. And maybe $9 per share for Celgene investors, too.

Bristol Myers Squibb announced they submitted an NDA for the multiple myeloma “ide-cel” CAR-T therapy Celgene developed in partnership with bluebird. The therapy is one of the three that has to be approved to unlock the BMS-Celgene contingent value agreement that would give shareholders of the absorbed NJ company $9 per share. The first, ozanimod, was approved last week. The second, a CAR-T treatment for non-Hodgkin’s lymphoma called liso-cel, was submitted to the FDA in December.