For years, the biggest push in psy­che­del­ic drug de­vel­op­ment has been around MD­MA, a par­ty drug long thought to have po­ten­tial ben­e­fits for pa­tients with PTSD. Rick Doblin, for years psy­che­del­ic ther­a­py’s most promi­nent ad­vo­cate and fundrais­er, and his non-prof­it, MAPS, have raised mil­lions to ad­vance clin­i­cal tri­als, most re­cent­ly rais­ing $30 mil­lion to com­plete a Phase III study in vet­er­ans.

But ATAI, the Ger­man-born biotech that has quick­ly be­come the most promi­nent pri­vate pro­mot­er and dri­ver of psy­che­del­ic ther­a­py, still thinks they have some­thing to of­fer. Yes­ter­day, the port­fo­lio an­nounced their lat­est sub­sidiary: Em­path­Bio.

Srini­vas Rao

The idea be­hind Em­path­Bio is that Doblin’s ap­proach, while promis­ing, will on­ly rep­re­sent MD­MA 1.0. In a a re­cent MAPS analy­sis of pooled Phase II stud­ies – not a per­fect­ly sound mea­sure but good enough to sup­port more stud­ies – about half of the 100 pa­tients who re­ceived the drug didn’t have the di­ag­nos­tic symp­toms for PTSD two months af­ter their last dos­ing. The prob­lem, said ATAI CSO Srini­vas Rao, is that the drug has to be ad­min­is­tered over mul­ti­ple days in fa­cil­i­ties where pa­tients are su­per­vised by trained pro­fes­sion­als for hours.

“The chal­lenge with MD­MA as it’s en­vi­sioned by MAPS is that it’s dif­fi­cult to de­ploy and to scale up,” Rao told End­points News. “What we want to do is tran­si­tion this more to an out­pa­tient, or day-ther­a­py type of ap­proach, so we’re look­ing at com­pounds that are po­ten­tial­ly safer.”

The com­pa­ny re­mains far from the clin­ic, but they will work on MD­MA-like com­pounds that they say have a bet­ter pro­file. With at least one oth­er com­pa­ny, no­tably Kures, ATAI and its sub­sidiaries have tweaked gener­ic, plant or oth­er non-patentable mol­e­cules in large part to make them patentable, en­sur­ing there’s a vi­able com­mer­cial path­way.

But Em­path­Bio CEO Glenn Short point­ed to the po­ten­tial for some of these tweaks to re­duce hy­per­ten­sion of MD­MA, al­low­ing it to be giv­en pa­tients with co-mor­bidi­ties, as well as al­low­ing it to be giv­en over short­er pe­ri­ods of time and in less con­trolled set­tings, al­low­ing pa­tients to re­ceive the drug in rur­al and oth­er ar­eas.

Aca­dia adds to pain pipeline 

Aca­dia has been adding to its pipeline of late, most re­cent­ly pick­ing up new Alzheimer’s and de­men­tia can­di­dates in a mile­stone-heavy deal with Van­der­bilt Uni­ver­si­ty. Now, in a larg­er deal, they’ve added a new pre­clin­i­cal and ear­ly-stage clin­i­cal pipeline of pain drugs, buy­ing out Cer­Sci Ther­a­peu­tics for $52.5 mil­lion up­front and $887 mil­lion in mile­stones.

The com­pa­ny had been de­vel­op­ing for mul­ti­ple neu­ro­log­i­cal in­di­ca­tions but had been fo­cused on non-opi­oid painkillers for acute and chron­ic pain. A lead com­pound, ACP-044, was shown tol­er­a­ble in Phase I stud­ies. Aca­dia said a Phase II study is planned for next year.

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

William B Crews had been a public affairs specialist at the NIH’s National Institute of Allergy and Infectious Diseases.

That ended today when he informed the agency of his decision to retire, after he was identified as the managing editor at RedState, a prominent Trump loyalist website.

Crews’ RedState duties are performed under the alias streiff. While enjoying the benefits of pseudonymity, he disparaged and worked against NIAID with an incendiary level of rhetoric in the midst of a pandemic.

Having worked in parallel for years to move their respective PD-1 inhibitors up to the first-line treatment of gastrointestinal cancers, Merck and Bristol Myers Squibb finally have the data at ESMO for a showdown.

Comparing KEYNOTE-590 and CheckMate-649, of course, comes with the usual caveats. But a side-by-side look at the overall survival numbers also offer some perspective on a new frontier for the reigning checkpoint rivals, both of whom are claiming to have achieved a first.

Bausch Health is closing in on a deal that would allow it to buy out all of Allegro Ophthalmics’ eye-related assets — including the rights to lead candidate risuteganib — for $50 million.

The payment would be made in two tranches: $10 million at signing, and $40 million in 2021.

Risuteganib is in clinical development for intermediate dry Age-related Macular Degeneration (AMD). It’s expected to enter two concurrent Phase III trials for that indication in the next year. The drug is also being tested in patients with diabetic macular edema (DME), and last year met the primary endpoint in a Phase II study, with 48% of patients gaining 8 or more letters in visual acuity from baseline at week 28, compared to 7% in the control group at week 12.

Moving into earlier and earlier treatment lines, Bristol Myers Squibb is reporting that adjuvant treatment with Opdivo has doubled the time that esophageal or gastroesophageal junction cancer patients stay free of disease.

With the CheckMate-577 data at ESMO, CMO Samit Hirawat said, the company believes it can change the treatment paradigm.

While a quarter to 30% of patients typically achieve a complete response following chemoradiation therapy and surgery, the rest do not, said Ronan Kelly of Baylor University Medical Center. The recurrence rate is also high within the first year, Hirawat added.

President Donald Trump commented Monday morning that Pfizer’s Covid-19 vaccine candidate could be the first to win approval by regulators.

During an interview on a Fox News’ morning show, the president said Pfizer was doing “very well” when asked which candidate could be approved, according to a Reuters report. He added that J&J could follow up afterward, saying “they’ll probably be a little later.”

For the blockbuster potential of Novartis’ Tafinlar and Pfizer’s Braftovi, all the BRAF inhibitors on the market so far only target V600 mutations — which accounts for roughly 50% of patients.

Israeli biotech Novellus now has $57 million to develop a drug that they say can help the other 50% who have everything else.

The Series C will fund a Phase II trial for PLX-8394, a “paradox breaker” that could block RAF without activating MAPK signaling. In a Phase I trial, a patient with a BRAF fusion saw their tumor go away after taking the drug, allowing Novellus to hit the ground running.