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.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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Alaa Halawa, executive director at Mubadala’s US venture group

The ven­ture crew at Mubadala are up­ping their biotech cre­ation game, tak­ing care­ful aim at a new fron­tier in drug de­vel­op­ment

It started with a cup of coffee and a slow burning desire to go early and long in the biotech creation business.

Wrapping up a 15-year discovery stint at Genentech back in the summer of 2021, Rami Hannoush was treated to a caffeine-fueled review of the latest work UCSF’s Jim Wells had been doing on protein degradation — one of the hottest fields in drug development.

“Jim and I have known each other for the past 15 years through Genentech collaborations. We met over coffee, and he was telling me about this concept of the company that he was thinking of,” says Hannoush. “And I got immediately intrigued by it because I knew that this could open up a big space in terms of adding a new modality in drug discovery that is desperately needed in pharma.”

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Genen­tech to stop com­mer­cial man­u­fac­tur­ing at Cal­i­for­nia head­quar­ters

Genentech is halting commercial manufacturing at its California headquarters — and laying off several hundred employees.

The move is the result of a decision Genentech made in 2007 to relocate manufacturing operations from its South San Francisco headquarters location to other facilities or move the work to CDMOs, said Andi Goddard, Genentech’s SVP of quality and compliance for pharmaceutical technical operations, in an interview with Endpoints News. Genentech has made changes in capabilities and invested more in technology, so it doesn’t need as many large-scale manufacturing facilities as it did in the past, she said.

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Chat­G­PT with phar­ma da­ta de­buts for med­ical meet­ings, be­gin­ning with AACR

What do you get when you combine ChatGPT generative AI technology with specific pharma and clinical datasets? A time-saving tool that can answer questions about medical conference abstracts and clinical findings in seconds in one new application from ZoomRx called FermaGPT.

ZoomRx is debuting a public version of its generative AI product specifically for medical conferences beginning this week for the upcoming American Association for Cancer Research (AACR) annual meeting that runs April 14-19.

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Vas Narasimhan, Novartis CEO (Gian Ehrenzeller/Keystone via AP)

No­var­tis pulls the plug on UK-based car­dio­vas­cu­lar study

Novartis is calling off a UK-based trial for Leqvio in the primary prevention of cardiovascular events in patients with high cholesterol, the company confirmed on Wednesday.

The Swiss pharma giant made the decision after “careful evaluation,” a spokesperson told Endpoints News via email. The trial, dubbed ORION-17, was planned in partnership with England’s National Health Service (NHS) and was part of the company’s strategy to establish Leqvio as a standard of care in cardiovascular disease management.

FDA re­jects Ab­b­Vie's in­fu­sion ther­a­py for Parkin­son's, re­quests more in­fo on pump de­vice

The FDA rejected AbbVie’s 24-hour infusion therapy for Parkinson’s, saying it needs more information on a device used to administer the treatment before it can clear it.

The Chicago-area drugmaker said in a press release that the complete response letter from the agency didn’t include any requests for more efficacy or safety trials related to the drug, known as ABBV-951. The company said it aims to “resubmit the NDA as soon as possible.”

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Quince Ther­a­peu­tics faces takeover bid from share­hold­er Echo Lake Cap­i­tal

A bid to take over the biotech Quince Therapeutics has been put forward by one of its shareholders.

On Tuesday, Echo Lake Capital sent a letter to Quince’s board of directors putting forth a proposal to acquire all the biotech’s stock for $1.60 per share, which would value a takeover at around $58 million.

In the letter, Echo Lake said that it believes Quince’s stock is severely undervalued and that no drugs are being actively marketed or developed that require cash expenditures. It’s trading below the value of its assets, Echo Lake said.

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Rohan Palekar, 89bio CEO

89bio’s PhII da­ta add to quick suc­ces­sion of NASH read­outs as field seeks turn­around

89bio said its drug was better than placebo at lessening fibrosis without worsening nonalcoholic steatohepatitis, or NASH, in two of three dose groups.

The San Francisco biotech said it thinks the Phase IIb data pave the way for a potential Phase III, following in the footsteps of another biotech in its drug class, Akero Therapeutics. To fund a late-stage study, CEO Rohan Palekar told Endpoints News 89bio “would need to raise additional capital,” with the company having about $188 million at the end of last year.