Amit Etkin, Alto Neuroscience CEO (Alto via Vimeo)

A star Stan­ford pro­fes­sor leaves his lab for a start­up out to re­make psy­chi­a­try

About five years ago, Amit Etkin had a break­through.

The Stan­ford neu­rol­o­gist, a soft-spo­ken de­mi-prodi­gy who be­came a pro­fes­sor while still a res­i­dent, had been ob­sessed for a decade with how to bet­ter de­fine psy­chi­atric dis­or­ders. Drugs for de­pres­sion or bipo­lar dis­or­der didn’t work for many pa­tients with the con­di­tions, and he sus­pect­ed the rea­son was how tra­di­tion­al di­ag­noses didn’t ac­tu­al­ly get at the heart of what was go­ing on in a pa­tient’s brain.

He had shown in 2006 that some pa­tients with dif­fer­ent di­ag­noses — PTSD vs. de­pres­sion, for ex­am­ple — looked re­mark­ably sim­i­lar un­der brain imag­ing, sug­gest­ing clin­i­cians drew dis­tinc­tions in the wrong places. And in 2014, he showed that one could de­fine pa­tients by look­ing at in­di­vid­ual dis­crete be­hav­iors, such as at­ten­tion or sleep.

But the big ad­vance came in 2017, when his team demon­strat­ed it could pre­dict PTSD pa­tients’ re­sponse to ther­a­py by just look­ing at their brain­waves. Sim­i­lar pre­dic­tions, aid­ed with a bit of AI, fol­lowed for oth­er dis­or­ders.

“So those are the tools that re­al­ly got us ex­cit­ed,” Etkin told End­points News. “And then of course, the main ques­tion that you can’t an­swer in the lab is, how do you de­vel­op new ther­a­peu­tics around this?”

So Etkin left the lab, turn­ing his back on a bur­geon­ing aca­d­e­m­ic ca­reer to found and a run a start­up around his pre­dic­tive tech­nol­o­gy. The com­pa­ny, known as Al­to Neu­ro­science, an­nounced a $32 mil­lion Se­ries A Thurs­day, with plans to launch three Phase IIa tri­als for treat­ment-re­sis­tant de­pres­sion and PTSD with­in the next year and have its first da­ta by 2023.

With the launch, Al­to joins a grow­ing boom in neu­ro­science R&D, a field that much of big phar­ma aban­doned over the last decade.

Amit Etkin with a stu­dent

Click on the im­age to see the full-sized ver­sion

This resur­gence has been pred­i­cat­ed in part on new tech­nolo­gies, in­clud­ing the abil­i­ty to bet­ter di­vide and clas­si­fy pa­tients by their bi­ol­o­gy. Last week, ARCH, Am­gen and a long list of oth­er in­vestors threw $500 mil­lion be­hind Neumo­ra, a biotech that promis­es to use a host of dif­fer­ent met­rics and datasets to come up with so-called “pre­ci­sion phe­no­types” — pop­u­la­tions most like­ly to re­spond to a giv­en mol­e­cule.

Al­to will try to do some­thing sim­i­lar with Etkin’s tech­nol­o­gy. The pro­fes­sor-turned-CEO and his team have spent more than a year go­ing through 200-plus mol­e­cules that have been ap­proved or put in clin­i­cal de­vel­op­ment for psy­chi­atric dis­or­ders.

They did deep dili­gence on 21 of them, look­ing for those that had gone through Phase I for safe­ty and shown the right kind of bi­o­log­i­cal ac­tiv­i­ty. They in-li­censed 11 and plan to even­tu­al­ly push each in­to a psy­chi­atric sub-pop­u­la­tion that, ei­ther be­cause of a giv­en be­hav­ior or EEG pat­tern or oth­er bio­mark­er, they think will re­spond.

Etkin views the hun­dreds of failed psy­chi­a­try drugs from the last few decade as sim­ply “tools that ma­nip­u­late the brain in some use­ful way.” His goal is to find the best place to use them.

“We have all of these tools sit­ting around that we don’t quite know how to use, and we have all this bi­ol­o­gy that we’ve been flesh­ing out over these years,” he said. “This is re­al­ly how we struc­tured Al­to in terms of the strat­e­gy: to take all that knowl­edge from the past 30 years in phar­ma and biotech, and put it to work in a tar­get­ed and mean­ing­ful way.”

Etkin found his main backer in a pro­tag­o­nist of the new neu­ro boom: Chris­t­ian Anger­may­er, the Ger­man bil­lion­aire who found­ed and large­ly fund­ed ATAI, the now-$2 bil­lion com­pa­ny try­ing to de­vel­op psy­che­delics for a panoply of psy­chi­atric dis­or­ders. His firm Ape­iron led the Se­ries A.

Chris­t­ian Anger­may­er

“Al­to is well-po­si­tioned to rev­o­lu­tion­ize the treat­ment of psy­chi­atric dis­or­ders by align­ing the right pa­tient with the right drug,” he said. “At Ape­iron, we have seen re­cent ad­vance­ments at­tempt­ing to ex­pand the toolk­it for men­tal well-be­ing but con­tin­ue to rec­og­nize the dire need to im­prove the way drugs are de­vel­oped in this space.”

The com­pa­ny is keep­ing its 11 mol­e­cules un­der wraps for now, in­clud­ing the three it plans to soon put in­to Phase IIa tri­als. Those stud­ies, Etkin said, will hope­ful­ly let Al­to prove they can de­vel­op bio­mark­ers to pre­dict the best pa­tients to re­spond, al­low­ing them to de­sign piv­otal tri­als just around that group.

It’s the be­gin­ning of what Etkin hopes will be a sea change across the field, to­ward some­thing that looks a lot clos­er to where on­col­o­gy is to­day.

“In five years, in our mind, we’ve com­plete­ly changed psy­chi­a­try, we’ve changed in­to a much more pre­cise prac­tice,” he said. “And the frus­tra­tion of tri­al and er­ror for both pa­tients and clin­i­cians is — if not gone — is cer­tain­ly on the way to get­ting there.”

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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David Ricks, Eli Lilly CEO (David Paul Morris/Bloomberg via Getty Images)

Eli Lil­ly set to in­vest $2.1B in home state man­u­fac­tur­ing boost

Eli Lilly is looking to expand its footprint in its home Hoosier State by making a major investment in manufacturing.

The pharma is investing $2.1 billion in two new manufacturing sites at Indiana’s LEAP Lebanon Innovation and Research District in Boone County, northwest of Lilly’s headquarters in Indianapolis.

The two new facilities will expand Lilly’s manufacturing network for active ingredients and new therapeutic modalities, including genetic medicines, according to a press release.

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US sees spike in Paxlovid us­age as Mer­ck­'s mol­nupi­ravir and As­traZeneca's Evusheld are slow­er off the shelf

New data from HHS show that more than 162,000 courses of Pfizer’s Covid-19 antiviral Paxlovid were administered across the US over the past week, continuing a streak of increased usage of the pill, and signaling not only rising case numbers but more awareness of how to access it.

In comparison to this week, about 670,000 courses of the Pfizer pill have been administered across the first five months since Paxlovid has been on the US market, averaging about 33,000 courses administered per week in that time.

Pfiz­er and CD­MOs ramp up Paxlovid man­u­fac­tur­ing with Kala­ma­zoo plant ex­pan­sion lead­ing the way

As the Covid-19 pandemic continues to evolve, pharma companies and manufacturers are exploring how to step up production on antivirals.

Pfizer is planning to expand its Kalamazoo-area facility to increase manufacturing capabilities for the oral Covid-19 antiviral Paxlovid, according to a report from Michigan-based news site MLive. The expansion of the facility, which serves as Pfizer’s largest manufacturing location, is expected to create hundreds of “high-skilled” STEM jobs, MLive reported. No details about the project’s cost and timeline have been released, but according to MLive, Pfizer will announce the details of the expansion at some point in early June.

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FDA spells out the rules and re­stric­tions for states seek­ing to im­port drugs from Cana­da

The FDA is offering more of an explanation of the guardrails around its program that may soon allow states to import prescription drugs in some select circumstances from Canada, but only if such imports will result in significant cost reductions for consumers.

While the agency has yet to sign off on any of the 5 state plans in the works so far, and PhRMA’s suit to block the Trump-era rule allowing such imports is stalled, the new Q&A guidance spells out the various restrictions that states will have to abide by, potentially signaling that a state approval is coming.

Peter Thompson, Terremoto Biosciences interim CEO

For­mer Prin­cip­ia team looks to shake up co­va­lent small mol­e­cules again, this time at 'earthquake' scale

Terremoto Biosciences goes back a long ways, in a sense, to about a dozen years ago when Principia Biopharma was founded by UCSF professor Jack Taunton. Peter Thompson initially helmed the biotech.

The company helped expand covalent small molecule inhibitors beyond oncology and into autoimmune disease by targeting cystine. But that amino acid is uncommon in a lot of proteins, offering fewer drug targets than, say, lysine, which is present in most proteins of interest. So, over the years, Taunton went back to the drawing board to check out that second amino acid.

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Pfizer CEO Albert Bourla at the World Economic Forum (Gian Ehrenzeller/Keystone via AP Images)

All about ac­cess: Pfiz­er moves to a non-prof­it mod­el for drug sales in 45 low­er-in­come coun­tries

Leading the way to increase access to cheaper drugs worldwide, Pfizer said Wednesday it will provide all current and future patent-protected medicines and vaccines available in the US or EU on a not-for-profit basis to about 1.2 billion people in 45 lower-income countries.

Rwanda, Ghana, Malawi, Senegal and Uganda are the first five countries to sign on to this accord, which will also seek to blaze new paths for quick and efficient regulatory and procurement processes to reduce the usual delays in making new medicines and vaccines available in these countries.

Almirall is tapping artificial intelligence on behalf of its sales force for insights and efficiencies. (via Shutterstock)

Almi­rall rolls out sales rep ar­ti­fi­cial in­tel­li­gence sys­tem, cut­ting pre-call prep and 'wind­shield time'

Dermatology specialty pharma Almirall is making its sales reps smarter. Not with extra training or educational courses, but instead with artificial intelligence tools.

It began a soft launch of a sales rep AI and machine learning platform it calls Polaris last August in one of its 7 US coverage regions. The platform from Aktana gathers information from across Almirall internal sources and external ones – such as claims and prescribing data – to generate insights for reps. Now, instead of spending hours prepping for a sales call, Polaris can generate details about a physician’s preferences, past behaviors and prescription habits for reps in minutes, said Almirall head of commercial operations Vincent Cerio.

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Te­va, Al­ler­gan reach yet an­oth­er opi­oid set­tle­ment — ef­fec­tive­ly end­ing WV tri­al

Teva and Allergan have reached settlements with multiple states over their involvement in the opioid crisis. Their latest is worth 9 figures.

West Virginia attorney general Patrick Morrisey announced the newest settlement, worth $161.5 million, at a press conference on Wednesday. The deal would resolve claims that the companies helped fuel the state’s opioid epidemic. If it goes through, it could become the largest state-negotiated settlement in West Virginia’s history, according to Reuters.