EIP Phar­ma flies in­to a high-risk PhI­Ib Alzheimer’s study fu­eled with $20.5M from bil­lion­aire Len Blavat­nik’s Ac­cess In­dus­tries

John Alam

Un­de­terred by the string of fail­ures plagu­ing Alzheimer’s drug de­vel­op­ment, a young start­up based in Cam­bridge, MA has tapped an un­con­ven­tion­al source for $20.5 mil­lion to ad­vance a re­pur­posed drug in the clin­ic.

The new funds — com­ing from bil­lion­aire Len Blavat­nik’s Ac­cess In­dus­tries — will pow­er EIP Phar­ma’s Phase IIb study of ne­flamapi­mod, a p38 ki­nase in­hibitor in-li­censed from Ver­tex Phar­ma. Named RE­VERSE-SD, the high-risk tri­al will mea­sure im­prove­ment in episod­ic mem­o­ry as a pri­ma­ry end­point and have sev­er­al sec­ondary end­points in­clud­ing Clin­i­cal De­men­tia Rat­ing Scale Sum-of-Box­es, Wech­sler Mem­o­ry Scale, and spinal flu­id bio­mark­ers of dis­ease pro­gres­sion.

The fo­cus here is on cog­ni­tion — a gold stan­dard cheered on by the FDA in a set of guid­ance doc­u­ments re­leased in Feb­ru­ary. They came just in time for EIP Phar­ma, which launched RE­VERSE-SD in March.

“That’s the first time they’ve said that be­cause they rec­og­nize that it’s re­al­ly hard in the ear­ly stages of Alzheimer’s and in mild Alzheimer’s dis­ease to show an ef­fect on, for ex­am­ple, rates of go­ing in­to a nurs­ing home, be­cause that hap­pens lat­er on,” CEO John Alam tells me. “What mat­ters to pa­tients — when they first get di­ag­nosed — is the mem­o­ry func­tion.”

By tar­get­ing dys­func­tion­al neu­rons and the synaps­es that con­nect them, Alam be­lieves, their drug can di­rect­ly ad­dress mem­o­ry deficits. As such, their study will be “re­al­ly well aligned with the new FDA guid­ance doc­u­ment in terms of how we de­fine ear­ly Alzheimer’s dis­ease and how we’re mea­sur­ing drug ef­fect,” says Alam, a for­mer Ver­tex CMO who head­ed Sanofi’s ag­ing unit be­fore mov­ing on to start EIP Phar­ma.

Len Blavat­nik

By the time EIP was found­ed in 2014, Ver­tex was al­ready well in­to mid-stage de­vel­op­ment with ne­flamapi­mod, al­beit in non-CNS dis­or­ders. Hav­ing in­her­it­ed full sets of an­i­mal test­ing, Phase I and Phase II clin­i­cal da­ta — along­side an es­tab­lished man­u­fac­tur­ing process — the biotech went straight to Phase IIa, which yield­ed pos­i­tive re­sults ear­li­er this year.

That’s ad­vanced com­pared to the new­com­ers work­ing on nov­el path­ways in Alzheimer’s — a high pro­file start­up, De­nali Ther­a­peu­tics, has on­ly re­cent­ly be­gan Phase I test­ing; Rodin Ther­a­peu­tics, which is work­ing on synap­tic re­silience, has yet to en­ter the clin­ic — and Alam was quick to point it out.

“The things that are in Phase III to­day, the idea for them and con­cep­tion work­ing on them start­ed 10 or more years ago,” he says. “What we’re work­ing on, and the mech­a­nism we’re work­ing on, is tru­ly the state of the art sci­ence of our un­der­stand­ing of [how] ac­tu­al­ly mem­o­ry deficits form.”

Ground­work laid by Ver­tex had al­so al­lowed EIP Phar­ma to be cap­i­tal ef­fi­cient pri­or to this point, en­list­ing a small group of 10 in­di­vid­ual in­vestors to back their ear­li­er study. And it’s that pri­vate net­work that con­nect­ed Alam’s team to Ac­cess In­dus­tries, the first in­sti­tu­tion­al backer.

While Ac­cess had not been known for mak­ing a lot of life sci­ence in­vest­ments, Blavat­nik, the ec­cen­tric bil­lion­aire founder of Ac­cess, had backed biotechs through Clal Bio­sciences and dished out bio­med­ical sci­ence grants at top in­sti­tu­tions around the world. He was, how­ev­er, not di­rect­ly in­volved in the round.

Ac­cess could not be reached for com­ment. Ac­cord­ing to Alam, the two par­ties bond­ed over a vi­sion for the long term — a work­ing drug for Alzheimer’s pa­tients, not a quick ex­it.

Down the line, EIP Phar­ma’s ap­proach to synap­tic dys­func­tion could touch “more or less every CNS dis­or­der,” from Parkin­sons and Hunt­ing­ton’s dis­ease to autism and stroke re­cov­ery mech­a­nisms. But for now, they will con­cen­trate on chas­ing the suc­cess that’s elud­ed one big play­er af­ter an­oth­er.

“We have a re­al­ly good shot,” Alam says.

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In the past couple of years, something curious has happened: Pharma and VC dollars started gushing into neuroscience research.

Biogen’s controversial new Alzheimer’s drug Aduhelm has been approved on the basis of removing amyloid plaque from the brain, but the new neuro-focused pharma and biotechs have much loftier aims. Significantly curbing or even curing the most notorious disorders would prove the Holy Grail for a complex system that has tied the world’s best drug developers in knots for decades.

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Bob Bradway, Amgen CEO (Scott Eisen/Bloomberg via Getty Images)

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Ryan Watts, Denali CEO

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During the recent Annual ASCO Meeting, thousands of cancer researchers and clinicians from across the globe joined together virtually to present and discuss the latest findings and breakthroughs in cancer research and care. There were more than 5000+ scientific abstracts presented during this event, yet only a handful involved the use of motion-tracking wearables to collect digital measures relating to activity, sleep, mobility, functional status, and/or quality of life. Although these results were a bit disappointing, they should come as no surprise to those of us in the wearable technology field.

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Look­ing to repli­cate Covid-19 suc­cess in neu­ro, BioN­Tech back­ers bet on AC Im­mune and its new­ly-ac­quired Parkin­son's vac­cine

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The company helmed by former GlaxoSmithKline vet Paul Peter Tak made its way to Nasdaq thanks to a $72 million raise, which was downsized by about 15% than originally anticipated, according to Renaissance Capital. Candel priced at $8 per share after initially seeking to launch in the $13 to $15 range.

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As public and private companies stare down the reality of the Delta variant, many are now requiring that their employees or students be vaccinated against Covid-19 prior to attending school or to returning or starting a new job. Claims that such mandates are illegal or cannot be used for vaccines under emergency use authorizations have now been dismissed.

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Flush with the success of its mRNA Covid-19 vaccine, BioNTech is now gearing up for one of the biggest challenges in vaccine development — which comes without potential profit.

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