Psilocybin mushrooms (via The Denver Post)

In a key step for psy­che­del­ic re­search, mag­ic mush­room com­pound clears first clin­i­cal safe­ty hur­dle

Ex­as­per­at­ed with the of­ten-in­ef­fec­tive ex­ist­ing slate of an­ti­de­pres­sants, COM­PASS Path­ways set up shop in Lon­don 2016 — and made a bee­line for psilo­cy­bin, the psy­choac­tive in­gre­di­ent in mag­ic mush­rooms.

On Wednes­day, the start­up said its man-made ver­sion of the chem­i­cal — which is il­le­gal across ge­o­gra­phies in its nat­ur­al fun­gi form — had been well-tol­er­at­ed in an ear­ly-stage, place­bo-con­trolled tri­al in 89 healthy vol­un­teers.

Al­though pre­vi­ous re­search sup­ports the use of psilo­cy­bin in re­liev­ing symp­toms of de­pres­sion, small­er stud­ies are not al­ways place­bo-con­trolled. The tri­al test­ing the COM­PASS com­pound is the largest con­trolled study of psilo­cy­bin to date, said the study’s lead in­ves­ti­ga­tor, James Ruck­er of King’s Col­lege Lon­don’s In­sti­tute of Psy­chi­a­try, Psy­chol­o­gy & Neu­ro­science, in a state­ment.

Ex­ist­ing an­ti­de­pres­sants typ­i­cal­ly come in a pill form, and take weeks to kick in. J&J’s phar­ma­ceu­ti­cal con­coc­tion of ke­t­a­mine — the no­to­ri­ous par­ty drug that is al­so a horse and cat tran­quil­iz­er — was ap­proved ear­li­er this year, comes in the form of a nasal spray.

Tra­cy Che­ung

In the COM­PASS tri­al, vol­un­teers were ran­dom­ized to re­ceive a 10 mg or 25 mg dose of the syn­the­sized chem­i­cal (en­cap­su­lat­ed in a pill) or giv­en place­bo. Once dosed, vol­un­teers were giv­en in­di­vid­ual sup­port from ther­a­pists in groups of six in ses­sions that last­ed up to six hours.

The pa­tients who got the drug will most like­ly have ex­pe­ri­enced some psy­che­del­ic ef­fect, which is why the ther­a­pists were avail­able on hand, COM­PASS’ chief com­mu­ni­ca­tions of­fi­cer Tra­cy Che­ung not­ed in an in­ter­view with End­points News.

“Some­times that can be a lit­tle bit fright­en­ing or a lit­tle bit in­tense and the ther­a­pist is just there to hold your hand if that’s what’s re­quired and just pro­vide some sup­port or just to kind of say it’s all right, I’m here.”

No se­ri­ous ad­verse events emerged, and the most com­mon side ef­fects — as ex­pect­ed — were in the psy­che­del­ic realm, in­clud­ing changes in sen­so­ry per­cep­tion. The com­pound, dubbed COMP360, al­so had no im­pact on cog­ni­tive and emo­tion­al func­tion­ing, the com­pa­ny said.

COM­PASS is al­so con­duct­ing a Phase II tri­al test­ing its psilo­cy­bin com­pound in 216 pa­tients with treat­ment-re­sis­tant de­pres­sion across sites in North Amer­i­ca and Eu­rope. The com­pa­ny ex­pects to re­port da­ta from this study, which does not in­clude a place­bo arm, by ear­ly 2021.

Psilo­cy­bin is a sub­stance that in most re­gions is clas­si­fied as hav­ing no med­i­c­i­nal val­ue, falling in the same cat­e­go­ry as chem­i­cals such as LSD.

“At the mo­ment…we can use it but there’s an aw­ful lot of pa­per­work and we have to get li­cens­es for each of the coun­tries that we’re work­ing on do­ing the clin­i­cal tri­al,” Che­ung said, not­ing that the com­pa­ny has raised £28 mil­lion so far to in­ves­ti­gate the drug.

Psy­choac­tive in­gre­di­ents, whether de­rived from cannabis, LSD or mag­ic mush­rooms, have long cap­ti­vat­ed men­tal health re­searchers. Nav­i­gat­ing the com­plex le­gal hur­dles to ac­cess these com­pounds has thawed the pace of re­search but with mo­ti­vat­ed sci­en­tists and a grow­ing bur­den of poor­ly treat­ed men­tal health con­di­tions, the ecosys­tem of psy­che­del­ic re­search has ex­plod­ed. In Sep­tem­ber, John Hop­kin’s un­veiled it had scored $17 mil­lion to open its very own cen­ter of psy­che­del­ic re­search to ex­plore the im­pact of psy­che­del­ic com­pounds on cre­ativ­i­ty and well-be­ing.

But the brim­ming en­thu­si­asm comes with a healthy dose of skep­ti­cism. Crit­ics wor­ry that the bur­geon­ing re­search could in­cen­tivize un­bri­dled use of non-phar­ma­ceu­ti­cal ver­sions of these drugs and that clin­i­cal tri­al da­ta could be cloud­ed by the fact that place­bo-con­trolled stud­ies are not nec­es­sar­i­ly dou­ble-blind­ed, be­cause it is far too easy to de­ter­mine which group of pa­tients have been giv­en a place­bo.

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.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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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 face plants 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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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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Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

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.

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.

Clover Biopharmaceuticals announced Wednesday that its vaccine candidate showed 79% efficacy against the Delta variant in a Phase II/III trial dubbed Spectra, and 67% effective against Covid-19 overall.

Jean Bennett (Brent N. Clarke/Invision/AP Images)

Lux­tur­na in­ven­tor Jean Ben­nett starts a new gene ther­a­py com­pa­ny to tack­le rare dis­eases left be­hind by phar­ma, VCs

A few years ago Jean Bennett found herself in a surprising place for a woman who invented the first gene therapy ever approved in the United States: No one, it seemed, wanted her work.

Bennett, who designed and co-developed Luxturna, approved in 2018 for a rare form of blindness, had kept building new gene therapies for eye diseases at her University of Pennsylvania lab. But although the results in animals looked promising, pharma companies and investors kept turning down the pedigreed ophthalmology professor.

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Maureen Hillenmeyer, Hexagon Bio CEO

Hexa­gon Bio rais­es $61M to con­tin­ue ef­forts to turn fun­gi in­to drugs

A year after raising a $47 million launch round, the fungi-loving drug hunters at Hexagon Bio have more than doubled their coffers.

Hexagon announced today that it raised another $61 million for its efforts to design cancer and infectious disease drugs based on insights mined from the DNA in millions of species of fungi. The new financing brings Hexagon’s committed funding to over $108 million.