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.”

Un­pack­ing the Aduhelm de­ci­sion, Ver­tex's half full glass, a $525M J&J breakup, 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.

By now you have surely read about the FDA’s controversial approval of Biogen’s Alzheimer’s drug and all its reverberations. But I’d still recommend checking out the meaty recap below to make sure you didn’t miss all the angles that the Endpoints team has covered. If you’d rather look ahead, look no further than our three-day virtual panels next week at BIO, where we will discuss what the new normal means for every part of the industry.

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What does a clear ma­jor­i­ty of the bio­phar­ma in­dus­try think of the FDA ap­proval of ad­u­canum­ab? 'Hor­ri­fy­ing' 'Dan­ger­ous' 'Con­fus­ing' 'Dis­as­ter'

Over the years, we’ve become used to seeing a consensus emerge early in our industry polls at Endpoints News. And when we took the pulse of drug hunters on the heels of a controversial FDA approval for aducanumab this week, it became immediately apparent that the vast majority of our readers — heavily concentrated among biopharma staffers and execs — were incensed by what they had just witnessed.

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Aaron Kesselheim (Scott Eisen/AP Images for AIDS Healthcare Foundation)

Har­vard’s Aaron Kessel­heim re­signs from ex­pert pan­el in wake of ad­u­canum­ab OK, blast­ing FDA for ‘worst drug ap­proval de­ci­sion in re­cent U.S. his­to­ry'

A third member of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee has resigned in the wake of Biogen’s controversial Aduhelm approval, slamming the agency as he left and further deepening the controversy surrounding the decision.

Harvard University professor Aaron Kesselheim quit in protest Thursday afternoon, calling the Aduhelm OK “probably the worst drug approval decision in recent U.S. history.” Kesselheim follows both Joel Perlmutter, a neurologist from Washington University in St. Louis, and David Knopman, a neurologist from the Mayo Clinic, out the door.

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David Knopman (Mayo Clinic via YouTube)

A sec­ond ad­comm mem­ber aban­dons his post in af­ter­math of con­tro­ver­sial ad­u­canum­ab de­ci­sion

As the fallout from the FDA’s approval of Alzheimer’s med aducanumab grows, a second member of the adcomm overseeing that drug’s review has walked away. But even with two experts now having resigned from that committee in protest, is there enough broad-level outrage to prevent another aducanumab from getting approved?

The FDA on Wednesday lost another member of its Peripheral and Central Nervous System Drugs Advisory Committee as Mayo Clinic neurologist David Knopman hit the exit over the agency’s decision to approve Biogen’s Alzheimer’s drug Aduhelm despite the committee’s near-unanimous vote against it.

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FDA au­tho­rizes about 10M J&J vac­cine dos­es, trash­es 60M more from trou­bled Emer­gent plant

The FDA on Friday released about 10 million doses of J&J’s vaccine for use, and disposed of another 60 million doses that were manufactured at the now-shuttered Emergent BioSolutions facility in Baltimore where cross-contamination occurred.

The agency said it’s not yet ready to allow the Emergent plant to be included in the J&J EUA, but that may occur soon. FDA came to the decision to authorize some of the doses after reviewing facility records and quality testing results.

The IPO 4-1-1: Four fil­ings, a pric­ing and a with­draw­al head­line this week's Nas­daq ac­tion as raise ap­proach­es $7.5B

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

Another week, another horde of biotechs is doing the Nasdaq dance.

This week saw four companies file their SEC paperwork ahead of expected debuts, another hit Nasdaq on Friday and a sixth formally withdrew its bid to go public. Aerovate Therapeutics, Ocean Biomedical and Acumen Pharmaceuticals all penciled in initial raises of $100 million, while Dermata Therapeutics is estimating a modest $18 million raise.

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Keiichi Fukuda, Heartseed CEO

Fresh off $598M deal with No­vo Nordisk, a Japan­ese stem cell com­pa­ny is on its way to the clin­ic with a dif­fer­ent ap­proach to treat­ing heart fail­ure

A common approach to treating heart failure with induced pluripotent stem cells involves grafting sheets of cells onto the surface of the heart to improve vascularization and blood flow. It’s the easiest method of transplantation — but you run the risk of not making an electrical connection with the heart and the cells not synchronizing with the patient’s heart muscle.

So what if you could inject spherical clusters of heart cells directly into the heart muscle wall? For Heartseed, that’s now the $37 million question.

Janet Woodcock, acting FDA commissioner, at Thursday's Senate Appropriations hearing (Bill Clark/CQ Roll Call via AP Images)

Sen­a­tors lam­bast new Alzheimer’s drug’s price but give Janet Wood­cock a free pass on the ap­proval de­ci­sion

Senate Finance Democrats took aim at Biogen’s pricey new Alzheimer’s drug on Thursday, but members on both sides of the aisle at a separate appropriations hearing didn’t question acting FDA commissioner Janet Woodcock on the approval.

“I was appalled that Biogen priced their Alzheimer’s drug approved by the FDA at $56,000 per year — I’m not going to debate whether this is effective or not, but it’s double the household median income for Michiganders over the age of 65,” Sen. Debbie Stabenow (D-MI) said at the finance hearing.

Reshma Kewalramani, Vertex CEO (BIO via YouTube)

UP­DAT­ED: Ver­tex strikes out on its lat­est big shot at a rare ge­net­ic dis­ease. But they're go­ing to keep on swing­ing

It’s been several months since Vertex culled one of its small molecules for alpha-1 antitrypsin deficiency (AATD), taking a big hit after evidence of liver damage surfaced in a key Phase II trial. Now we learned that the company has whiffed on its second shot, and there’s nothing left in the clinic to treat the rare genetic disease — but that won’t stop it from trying.

Despite avoiding the safety issues that plagued the last candidate, Vertex $VRTX is taking the axe to VX-864 after Phase II results revealed the magnitude of the drug’s response is “unlikely to translate into substantial clinical benefit.” As a result of the news, the company’s stock fell 12.5% after hours.

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