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The Readout Damian Garde & Meghana Keshavan

The microbiome’s big year starts with a preliminary success

Rebiotix, one of a handful of microbiome drug developers expecting major data this year, said its stool-based therapeutic for deadly Clostridium difficile infections was successful in a late-stage trial.

As STAT’s Kate Sheridan reports, the Rebiotix study marks the first positive Phase 3 result for the emerging microbiome industry. The drug, which is delivered as an enema, significantly reduced the number of people who had diarrhea within eight weeks of their treatment, the company said, a sign that C. difficile infections had ceased.

But the result, taken from a preliminary analysis, lacks the detailed data needed to be sure Rebiotix’s treatment is having a significant effect. Next up: Seres Therapeutics and Finch Therapeutics will disclose pivotal data of their own.

Read more.

Gilead donated remdesivir to the feds. Getting it to patients is proving disastrous

After the FDA cleared the Covid-19 drug remdesivir for emergency use last week, Gilead Sciences gave thousands of doses to the federal government for distribution. Now, hospitals trying to get their hands on the drug are running into an opaque, confusing system that has left patients waiting for treatment.

As STAT's Eric Boodman and Casey Ross report, about two dozen hospitals appear to have been chosen to receive the drug so far, but no one knows why they were picked — or who's doing the picking. Clinicians who spoke to STAT were baffled by the process, pointing out that some of the hospitals hardest hit by Covid-19 have been left without access to remdesivir.

“I’m scared and nervous,” said Peter Chin-Hong, a UCSF infectious disease doctor. "... We know who the vendor is — AmerisourceBergen — but we don’t actually know who is making the decision. Is it Trump? Is it FEMA? Is it science-informed?”

Read more.

Biotech’s biggest lottery ticket is going to come down to the wire

Bristol Myers Squibb’s $74 billion merger with Celgene has long since been cemented, but one of the deal’s sweeteners has become a twisting and suddenly dramatic narrative.

Under the terms of that agreement, Celgene’s former investors are entitled to $9 in cash for every share they own, provided three of the company’s drugs win approval on a certain timeframe. For JCAR017, a CAR-T therapy Celgene picked up in its acquisition of Juno Therapeutics, that deadline is New Year’s Eve.

Yesterday, we learned that the FDA wants more information on JCAR017, which means the expected date of approval got pushed back three months to Nov. 16. That leaves very little in the way of wiggle room for Celgene shareholders counting on a payday — and it introduces the possibility that JCAR017 will get rejected outright. 

Salim Syed, an analyst at Mizuho, dug up a bevy of examples from industry history in which similar delays didn’t prevent eventual approval. But that $9 lottery ticket, which trades on the open market, is currently valued at around $3.85, suggesting investors think there’s just a 40% chance Celgene’s drugs come through.

Maybe Valtrex is the Alzheimer’s drug we’ve been waiting for

A new study, conducted on human brain tissue in a lab, added credibility to the theory that Alzheimer’s disease that the virus behind herpes could be causing the neurodegenerative disorder.

As STAT’s Sharon Begley reports, scientists at Tufts University took an engineered model of a human brain and infected it with the herpes simplex virus. Within days, the brain developed plaque-like globs similar to the amyloid deposits in Alzheimer’s patients, and inflammation spiked, just as it does in humans with the disease. And when the researchers treated it with valacyclovir, marketed as Valtrex, inflammation dropped and many of the plaques cleared up.

The findings, while confined to a quasi-brain in a dish, lend weight to the idea that Alzheimer’s — or at least treating it — might be a microbial proposition. The NIH is running a trial testing whether Valtrex can make a difference for patients with mild Alzheimer’s, and Cortexyme, which raised about $80 million in an IPO last year, is studying whether targeting the bacteria responsible for gingivitis can benefit those with mild to moderate disease.

Read more.

Why the latest NASH data is a relief for the field

In a mid-stage trial, Novo Nordisk’s top-selling diabetes drug had a significant positive effect on NASH, an alarmingly prevalent liver disease that could be a pharmaceutical goldmine. But the study wasn’t a home run, leaving room for the many companies angling to lead the field.

Novo’s drug, the daily semaglutide, beat placebo at resolving the inflammatory symptoms of NASH without worsening fibrosis, the liver scarring that results from the disease. But semaglutide had no significant effect at actually reducing fibrosis, measured in stages of severity.

That likely comes as a relief for the likes of Intercept Pharmaceuticals, Genfit, NGM Biopharmaceuticals, and Madrigal Pharmaceuticals, all of which are developing NASH medicines with a different biological mechanism. There’s no guarantee that any of their therapies will improve liver scarring, but the risk that Novo’s already-successful diabetes treatment would corner the market appears to have dissipated. 

More reads

  • Watch: Moderna's top doctor on the future of the company's coronavirus vaccine. (STAT)
  • TG Therapeutics pulls victory from the jaws of defeat. (Evaluate Vantage)
  • FTC approves AbbVie’s $63 billion deal for Allergan amid scornful dissent. (STAT Plus)
  • Biotech CEOs share ideas for coping with coronavirus. (Wall Street Journal)

Thanks for reading! Until tomorrow,

Thursday, May 7, 2020

STAT

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