A turning point for microbiome medicines

Microbiome therapeutics are coming up on a pivotal moment, STAT’s Kate Sheridan writes. Three companies in this space plan to unveil late-stage trial results later this year — which will either validate the field, or cast doubt on whether drugging gut bugs and their ilk is even viable.

Seres Therapeutics, in particular, is being closely watched. Its oral C. diff treatment, SER-109, has Phase 3 results slated for release this summer. It has a lot to prove: The company had a disappointing Phase 2 readout back in 2016, which makes this forthcoming data make or break.

Is the FDA quietly trying to stymie drug importation?

The concept of importing cheaper drugs from abroad has been kicked around for decades. Now, in response to pressure from the Trump administration, the FDA has proposed a regulation that seemingly expedites state-run importation plans. However, one health care management consultant opines that this FDA policy is a false step.

Reading between the lines, the 44-page proposal makes it exceedingly difficult to import drugs from countries such as Canada. Importers would have to screen the drugs to ensure they're not damaged or counterfeit, have samples of each shipment tested at an FDA-approved lab, and much more — to say nothing of the reams of paperwork importers would have to complete to get any of this done.

So, sure, drug importation may be a possibility. But who will actually do it?

Targeting the proteins that trigger inflammation

Inflammation is a culprit in many a disease. And, often, immune flareups are triggered by NLRP3 — a protein that is now being carefully studied for its probable role in a rather long list of diseases. Several companies are interested in developing NLRP3 inhibitors, C&EN reports — but it’s difficult to know where to begin. The molecule plays such a critical role in the inflammatory response that it’s hard to gauge what impact blocking it will have on the human body. Will it be a magic bullet, or have disastrous effects? Too early to tell. But researchers are excited:

“A bunch of the top killers in the Western world are all associated with NLRP3 activation,” one NLRP3 scientist told C&EN. “So if you can take some kind of once-a-day pill and help prevent yourself from getting Alzheimer’s, Parkinson’s, cardiovascular disease, atherosclerosis, and chronic liver disease, and if there are no side effects, then why wouldn’t you?”

Buffett gets in on Biogen

Looks like Warren Buffett’s betting on Alzheimer's and aducanumab: Berkshire Hathaway recently bought 648,000 shares of Biogen, according to a regulatory filing. The billionaire has dabbled — just a touch — in biopharma, with Teva being one such stock in his portfolio.

But this foray into biotech is still uncommon for Buffett. It’s a small wager for Berkshire Hathaway — much less than 1% of Biogen shares — comparable to a non-mogul betting like $1 on the Super Bowl. What’s the point?

A turning point for microbiome medicines

Is the FDA quietly trying to stymie drug importation?

Targeting the proteins that trigger inflammation

Buffett gets in on Biogen

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