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.

Im­ple­ment­ing re­silience in the clin­i­cal tri­al sup­ply chain

Since January 2020, the clinical trials ecosystem has quickly evolved to manage roadblocks impeding clinical trial integrity, and patient care and safety amid a global pandemic. Closed borders, reduced air traffic and delayed or canceled flights disrupted global distribution, revealing how flexible logistics and supply chains can secure the timely delivery of clinical drug products and therapies to sites and patients.

Gen­mab ax­es an ADC de­vel­op­ment pro­gram af­ter the da­ta fail to im­press

Genmab $GMAB has opted to ax one of its antibody-drug conjugates after watching it flop in the clinic.

The Danish biotech reported Tuesday that it decided to kill their program for enapotamab vedotin after the data gathered from expansion cohorts failed to measure up. According to the company:

While enapotamab vedotin has shown some evidence of clinical activity, this was not optimized by different dose schedules and/or predictive biomarkers. Accordingly, the data from the expansion cohorts did not meet Genmab’s stringent criteria for proof-of-concept.

PhRMA sues Trump gov­ern­ment over drug im­por­ta­tion rule — days be­fore it's set to be ef­fec­tive

Ever since President Donald Trump floated the idea of using state-sponsored importation to lower drug prices, PhRMA has made its opposition abundant. Not only is the proposal dangerous and futile,  but the trade group has also argued that it may even be illegal.

Now that the FDA has issued its final rule permitting states to bring certain drugs from Canada, PhRMA is taking the government to court — just a few days before the rule is slated to take effect.

In fi­nal days at Mer­ck, Roger Perl­mut­ter bets big on a lit­tle-known Covid-19 treat­ment

Roger Perlmutter is spending his last days at Merck, well, spending.

Two weeks after snapping up the antibody-drug conjugate biotech VelosBio for $2.75 billion, Merck announced today that it had purchased OncoImmune and its experimental Covid-19 drug for $425 million. The drug, known as CD24Fc, appeared to reduce the risk of respiratory failure or death in severe Covid-19 patients by 50% in a 203-person Phase III trial, OncoImmune said in September.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,100+ biopharma pros reading Endpoints daily — and it's free.

Pascal Soriot (AP Images)

UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,100+ biopharma pros reading Endpoints daily — and it's free.

John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

UP­DAT­ED: Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,100+ biopharma pros reading Endpoints daily — and it's free.

News brief­ing: Gilead part­ner Gala­pa­gos sells off CRO for $37M; Polyphor bags $3.3M from CF Foun­da­tion

Close Gilead ally Galapagos is selling off one of its contract research organizations to a Polish pharma company.

Galapagos has agreed to sell 100% of the outstanding shares in the CRO Fidelta to Selvita, in a deal worth roughly $37 million expected to close in the first week of January. The acquisition is expected to nearly double Selvita’s revenues, the company says, as well as expand its drug discovery efforts.

Michelle Longmire, Medable CEO (Jeff Rumans)

Med­able gets $91M for vir­tu­al clin­i­cal tri­als, bring­ing to­tal raise to $136M

As biotechs look to get clinical studies back on track amid the pandemic, Medable returned to the venture well for the second time this year, bagging a $91 million Series C to build out its virtual trial platform.

The software provider recently launched three new apps for decentralizing clinical trials, and saw a 500% revenue spike this year. And it isn’t alone. Back in August, Science 37 secured a $40 million round for its virtual trial tech, with support from Novartis, Sanofi Ventures and Amgen. Patients and researchers are taking a liking to the online approach, suggesting regulators could allow it to become a new normal even after the pandemic is over.

Vas Narasimhan, Novartis CEO (Jason Alden/Bloomberg via Getty Images)

Vas Narasimhan's 'Wild Card' drugs: No­var­tis CEO high­lights po­ten­tial jack­pots, as well as late-stage stars, in R&D pre­sen­ta­tion

Novartis is always one of the industry’s biggest R&D spenders. As they often do toward the end of each year, company execs are highlighting the drugs they expect will most likely be winners in 2021.

And they’re also dreaming about some potential big-time lottery tickets.

As part of its annual investor presentation Tuesday, where the company allows investors and analysts to virtually schmooze with the bigwigs, Novartis CEO Vas Narasimhan will outline what he thinks are the pharma’s “Wild Cards.” The slate of five experimental drugs are those that Novartis hopes can be high-risk, high-reward entrants into the market over the next half-decade or so, and cover a wide range of indications.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,100+ biopharma pros reading Endpoints daily — and it's free.