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Wednesday, February 21, 2018

The Readout by Damian Garde & Meghana Keshavan

Welcome to The Readout, where we keep you on top of the latest in biotech. For more in-depth coverage of biopharma, subscribe to STAT Plus. On Twitter: @damiangarde@megkesh, and @statnews.

There's no pleasing some people

Announce a big clinical trial win and your stock price goes up a lot, right? Isn’t that the way this biotech investing game works?

Not if you're Aimmune Therapeutics. The company’s stock fell 6 percent Tuesday on what looks like really good news — an experimental treatment protected people with severe peanut allergy far better than a placebo, meeting the primary goal of a Phase 3 clinical trial. The problem: safety. The study results, while positive overall, also showed about 3 percent of kids suffered from potentially serious allergic reactions while undergoing treatment.

In other words, a therapy that does a remarkably effective job of protecting very vulnerable kids from severe peanut-related allergic reactions can actually cause the same adverse reaction in a small number of those kids.

Aimmune’s therapy will almost certainly be approved based on these study results — and the company is raising $150 million off the data — but will parents agree to treat their children with it? Or, will they choose a safer but less effective therapy from competitor DBV Technologies. Uncertainty is not a stock’s friend, so down Aimmune shares went.

Maybe don’t CRISPR yourself, self-CRISPR’er says

“There’s no doubt in my mind that somebody is going to end up hurt eventually,” said Josiah Zayner, the guy who months ago injected a CRISPR-edited serum into his arm in hopes of stimulating muscle growth akin to those famous swole dogs.

Now, he explains to the Atlantic, he’s having some regrets. “Everybody is trying to one-up each other more and more,” Zayner said, referring to a recent and particularly baffling display in which the CEO of a company called Ascendance Biomedical injected himself with an untested herpes treatment live on the internet and then ended up locking himself in a lab to calm a mutiny.

“What it’s turned into now, people view it as a way to get press and get publicity and get famous,” Zayner

Meanwhile, “USRM Posts Live Webinar with World Renowned Biohacker,” says this press release, where “USRM” is a Florida company being sued by three women who say its treatments cost them their sight, and the “World Renowned Biohacker” is a guy who just self-administered some “overall bioenhancement, as well as penile injections for erectile enhancement.” So there’s that.

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Reproducibility is a problem for more than mice

It goes without saying that the first time you see Alzheimer's disease cured in a mouse, you should consume the resulting enthusiasm with a corresponding helping of salt. But what about a discovery that has been borne out in a big trial on human beings?

A new study suggests late-stage clinical studies deserve similar skepticism, concluding that 1-in-3 earliest-to-publication trials reported benefits much greater than later research showed. These weren't fly-by-night trials detailed in predatory journals. They were Phase 3 studies, published in so-called high-impact journals, the stuff that lands on the front of The New York Times — or gets used to win FDA approval.

“We were surprised,” said Dr. M. Hassan Murad, a clinical epidemiologist and senior author of the study. “Studies that are well done — we looked at quality — are still unpredictable, which is problematic because it means you cannot really tell when such a thing will take place.”

Read more.

At long last, a scorecard update

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(Jennifer Keefe/STAT)

Speaking of Aimmune Therapeutics, the company's Phase 3 disclosure finally gives us cause to update the quarterly scorecard for just the third time since the dawn of the year.

Aimmune's data may have led to a muted reaction on Wall Street, but they did outstrip what we saw from rival DBV Technologies and its peanut allergy project last year, which means regardless of investors' short-term thoughts, the company is well-positioned in one of biotech's oft-discussed races.

Meanwhile, we like all of biotech await word from the likes of Incyte, Dermira, and BioHaven.

More reads

  • Biogen CEO calls share slump an overreaction to Alzheimer’s trial. (Wall Street Journal)
  • New Medicare rule could limit cancer patients’ access to genetic testing, physicians warn. (STAT)
  • With $69 million deal, AbbVie turns to Voyager for an Alzheimer’s gene therapy. (Xconomy)
  • Roche and Takeda try on Emulate’s ‘organ chip’ tech for R&D. (Endpoints)

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Thanks for reading! Until tomorrow,

Damian

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