There haven’t been a lot of big ven­ture rounds for biotech com­pa­nies look­ing to run a Phase II study in Alzheimer’s.

The field has been a dis­as­ter over the past decade. Amy­loid didn’t pan out as a tar­get — go­ing down in a litany of Phase III fail­ures — and is now mak­ing its last stand at Bio­gen. Tau is a com­er, but when you look around and all you see is de­struc­tion, the idea of back­ing a start­up try­ing to find com­plex cock­tails to swing the course of this dev­il­ish­ly com­pli­cat­ed mem­o­ry-wast­ing dis­ease would daunt the pluck­i­est in­vestors.

Which brings me to Athi­ra, a lit­tle, Seat­tle-based biotech that caught my at­ten­tion with a heads-up that they’re an­nounc­ing an $85 mil­lion round to­day to fund their Phase II/III quest for Alzheimer’s. Athi­ra’s team has been on a long, 9-year jour­ney to get here, and they are acute­ly aware of the burned-out wreck­age and dis­as­ter head­lines cov­er­ing the route that they have been cruis­ing.

To get the mon­ey, they en­list­ed a long line of back­ers: Per­cep­tive Ad­vi­sors for the lead with par­tic­i­pa­tion from new in­vestors RTW In­vest­ments, Viking Glob­al In­vestors, Ven­rock Health­care Cap­i­tal Part­ners, Franklin Tem­ple­ton, Rock Springs Cap­i­tal, LifeSci Ven­ture Part­ners, Sur­vey­or Cap­i­tal (a Citadel com­pa­ny), High­side Cap­i­tal Man­age­ment, Lo­gos Cap­i­tal, funds man­aged by Janus Hen­der­son In­vestors, Sofinno­va In­vest­ments, Avid­i­ty Part­ners, and ex­ist­ing in­vestors in­clud­ing Rick and Suzanne Kayne and Sah­sen Ven­tures.

Joe Edel­man, who runs the well-con­nect­ed Per­cep­tive, is join­ing the board af­ter giv­ing the crew a thumbs up.

So far, Athi­ra’s back­ers have put up about $20 mil­lion to get to this point, so you can see how big a deal this is to the biotech team.

There are in­vestors out there who have nev­er been burned by Alzheimer’s and who are still ready to con­sid­er jump­ing in, says CEO Leen Kawas, who’s been mak­ing the rounds, and then there have been plen­ty which have.

“I’m proud we put to­geth­er a syn­di­cate that in­cludes both,” she tells me.

Edel­man and the rest are back­ing a drug — NDX-1017 — that by­pass­es the whole tox­ic plaque de­bate and fo­cus­es on an­oth­er fa­mil­iar strat­e­gy: the frayed synap­tic net­work in the brain that erodes with the dis­ease. Boost the net­work and you can stop, pos­si­bly re­verse, the dam­age that cor­rodes cog­ni­tion. For awhile.

Their small mol­e­cule is de­signed to tar­get he­pa­to­cyte growth fac­tor (HGF) and its re­cep­tor, MET, in an ef­fort to re­gen­er­ate af­flict­ed tis­sue. And that’s some­thing these in­vestors haven’t seen be­fore.

Athi­ra got this far by spot­light­ing da­ta they say back up the ef­fi­ca­cy pro­file they’re look­ing for. In a Phase Ib, Kawas says, re­searchers used a test to gauge pa­tients’ abil­i­ty to count odd tones pep­pered in a string of re­peat­ed tones. For pa­tients with de­men­tia, their nor­mal pat­tern of recog­ni­tion falls in a 400 to 450 mil­lisec­ond range, says the CEO. Their base­line in the study was 390. In the drug arm, just 7 pa­tients, that dropped to an av­er­age of 311. There was no change among 4 place­bo pa­tients, says Kawas.

Now, they’ll need to see if they can repli­cate a cog­ni­tive im­prove­ment in a much larg­er Phase II. And then they can move on to a piv­otal Phase III. The FDA re­quires pos­i­tive da­ta from 2 con­trolled stud­ies, and that might be it. But Kawas knows that if they can’t con­vince reg­u­la­tors — bal­anc­ing the da­ta against the moun­tain­ous un­met need — they’d need to go on to a sec­ond Phase III.

The odds against suc­cess here are sig­nif­i­cant. Every­thing fails in Alzheimer’s. Or has. But win­ning over a syn­di­cate of in­vestors able to pro­vide that kind of cash is al­so val­i­dat­ing — and no mean achieve­ment in this en­vi­ron­ment.

Right now, the Athi­ra team has spent a good chunk of their lives de­vot­ed to see­ing if this drug can work. “We’re be­liev­ers that this can be done,” says the CEO.

It’s a daunt­ing up­hill climb, but they in­tend to make be­liev­ers out of every­one else as well. As some­where down the trail, the plan is to float an IPO down Wall Street to see if they can win over an even big­ger group of be­liev­ers.

The FDA on Tuesday released a warning letter sent earlier this month to the Mason, OH-based site of Procter & Gamble Manufactura, raising questions about the list of ingredients on the label and in the electronic filing.

The warning says that for P&G’s over-the-counter Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion, there’s a “mismatched” list of active ingredients between the labeling and the electronic listing file. The listing file for the active ingredients did not match the active ingredients in the electronic file.

The Federal Trade Commission has gotten involved in a patent feud over Supernus’ Parkinson’s drug Apokyn, a case the agency said may have ‘‘significant implications” for patients who rely on the drug.

Sage Chemical won the first generic approval for its Apokyn formulation (also known as apomorphine hydrochloride injection) back in 2022. The non-ergoline dopamine agonist is approved to treat Parkinson’s symptoms during “off episodes,” such as difficulty moving, tremors and intense cramping. However, regulators specified that the approval pertained to the generic drug cartridges only, not the injector pen required for administration.