Jonathan Sporn, Gilgamesh CEO

The Har­vard sci­en­tist act­ing as ATAI's trea­sure trove launch­es a new psy­che­delics firm fo­cused on drug 'ana­logues'

A for­mer Har­vard and NIH sci­en­tist is re­turn­ing to the psy­che­delics field with a new biotech af­ter sell­ing his last ef­fort to the buzzy ATAI Life Sci­ences.

Gil­gamesh Phar­ma­ceu­ti­cals com­plet­ed its $27 mil­lion Se­ries A on Thurs­day, the com­pa­ny an­nounced, with plans to use the cash to prep four pro­grams for INDs and con­tin­ue ex­pand­ing its lead­er­ship team. The biotech is led by CEO Jonathan Sporn, and it’s not his first rodeo in psy­che­delics.

Sporn pre­vi­ous­ly found­ed Per­cep­tion Neu­ro­science, fo­cus­ing on R-ke­t­a­mine for treat­ment-re­sis­tant de­pres­sion, and sold it to ATAI in ear­ly 2019. Per­cep­tion’s can­di­date is in ear­ly hu­man tests and is among the most ad­vanced in ATAI’s port­fo­lio.

Two oth­er mem­bers of his lead­er­ship team— his CSO and co-founder — al­so sold a com­pa­ny cen­tered around opi­oid use dis­or­der to ATAI last year in Kures. The col­lec­tive ex­pe­ri­ences among the group have cer­tain­ly helped Gil­gamesh get off the ground, Sporn told End­points News, but they want­ed to do things a lit­tle bit dif­fer­ent­ly this time around.

Sporn be­gan putting a team to­geth­er of what he called “un­usu­al” peo­ple for the space, main­ly med­i­c­i­nal chemists in­clud­ing the for­mer Kures lead­ers. These folks, Dal­i­bor Sames and An­drew Kruegel, had ex­ten­sive ex­pe­ri­ence in cre­at­ing and en­gi­neer­ing ana­logues to some of the more com­mon psy­che­del­ic drugs out there like ibo­gaine.

It’s the cre­ation of these ana­logues where Gil­gamesh will al­so spend its time and mon­ey, Sporn said, rather than try­ing to use things like syn­thet­ic psilo­cy­bin — the psy­choac­tive in­gre­di­ent in mag­ic mush­rooms that Com­pass Path­ways fo­cus­es on — or some­thing a bit more off­beat, like the drug col­lo­qui­al­ly known as ‘toad ven­om.’

“What we see with these oth­er com­pa­nies in the field, they seem to be fo­cus­ing more on things that al­ready ex­ist and where it’s a more com­plex process to try to pro­tect these things,” Sporn told End­points. “We’re more fo­cused on cre­at­ing the right group of peo­ple … we’re pulling to­geth­er the right peo­ple, it’s all very IP-cen­tric and very med­i­c­i­nal chem­istry-cen­tric.”

Gil­gamesh has al­so part­nered with NJ-based Psy­chogen­ics to use their AI plat­form, which he says was the first of its kind in psy­chi­a­try. Re­searchers ad­min­is­ter ex­per­i­men­tal drugs to mice and are ob­served by cam­eras that cat­a­logue their be­hav­ioral pat­terns, al­low­ing Gil­gamesh to mea­sure which dos­es are most ef­fec­tive and how long their ef­fects last af­ter leav­ing the body.

The com­pa­ny ex­pects to en­ter IND-en­abling stud­ies for two of its pro­grams over the next few months, the first of which is an oral ke­t­a­mine ana­logue like­ly to be stud­ied for treat­ment-re­sis­tant de­pres­sion and opi­ate use dis­or­der. This can­di­date’s ap­peal, Sporn says, is the oral for­mu­la­tion it­self: Gil­gamesh’s pill al­lows for few­er dis­so­cia­tive ef­fects and is much safer for home use or dur­ing psy­chother­a­py.

Sporn al­so high­light­ed an ana­logue of DMT Gil­gamesh is work­ing on, which is in­tend­ed to short­en the ther­a­peu­tic ef­fect from six hours to about one or two hours. That would ease the bur­den on the health­care sys­tem, as psy­chi­a­trists won’t have to spend all that time ob­serv­ing pa­tients af­ter tak­ing the drug. Gil­gamesh’s oth­er two pro­grams in­volve the sero­tonin re­cep­tor 5-HT2A.

With his ex­pe­ri­ence at Per­cep­tion and now at Gil­gamesh, Sporn says he’s been grate­ful to have a front row seat at this bur­geon­ing field. And he’s al­ready seen in­ter­est from mid-size phar­ma com­pa­nies in­ter­est­ed in ac­quir­ing Gil­gamesh. But for now, the fo­cus re­mains on build­ing out the team and en­sur­ing its pro­grams are full steam ahead.

“They’re start­ing to dip their toe in­to the wa­ter to look at ac­qui­si­tions in this space, or part­ner­ships in this space,” Sporn said. “It’s clear they’re in­ter­est­ed, and I think you’ll start to see more of that, more of those peo­ple be­gin­ning to cre­ate part­ner­ships around the space, and that will help, I think, a good deal.”

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.

Lat­est on ul­tra-rare dis­ease ap­proval; Pos­i­tive, if mixed, signs for Bio­gen's ALS drug; Clay Sie­gall finds a new job; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Over the last four years, we’ve honored 80 women whose extraordinary accomplishments have changed the game in biopharma R&D. You can now nominate someone to be highlighted in this year’s special report. Details are here.

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FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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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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No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

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Ly­me vac­cine test com­ple­tion is pushed back by a year as Pfiz­er, Val­ne­va say they'll ad­just tri­al

Valneva and Pfizer have adjusted the end date for the Phase III study of their investigational Lyme disease vaccine, pushing it back by a year after issues at a contract researcher led to thousands of US patients being dropped from the test.

In a March 20 update to, Valneva and Pfizer moved the primary completion date on the trial, called VALOR, from the end of 2024 to the end of 2025.

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Stuart Peltz, former PTC Therapeutics CEO

Stu­art Peltz re­signs as PTC Ther­a­peu­tics CEO af­ter 25 years

Stuart Peltz, the longtime CEO of PTC Therapeutics who’s led the rare disease drug developer since its founding 25 years ago, is stepping down.

Succeeding him in the top job is Matthew Klein, who joined PTC in 2019 and was promoted to chief operating officer in 2022. In a call with analysts, he said the CEO transition has been planned for “quite some time” — in fact, as part of it, he gave the company’s presentation at the JP Morgan healthcare conference earlier this year.

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Bet­ter Ther­a­peu­tics cuts 35% of staff while await­ing dig­i­tal ther­a­peu­tic ap­proval

Digital therapeutics company Better Therapeutics announced on Thursday that it’s cutting 35% of its staff as it awaits FDA clearance for its first product.

The company, which launched eight years ago, is one of a growing group of companies seeking a digital alternative to traditional medicine. The space saw a record $7.5 billion in investments in 2021, according to Chris Dokomajilar at DealForma, with uses spanning ADHD, PTSD and other indications. However, private insurers have been slow to hop on board.