The Readout Damian Garde & Meghana Keshavan

The world waits on word from Pfizer

Today, at 10 a.m. ET, Pfizer is either going to plod through the details of its financial performance over the past three months or make headlines around the globe with an update on the most advanced potential vaccine for Covid-19.

What we know is this: Pfizer’s vaccine trial is designed to have periodic check-ins once there have been a certain number of Covid-19 infections. If one of those check-ins reveals that the vaccine is dramatically outperforming placebo — or dramatically underperforming — the company will unblind the study and tell the world about it. According to Pfizer, the first analysis would be done after 32 cases of Covid-19, and the threshold for declaring the vaccine a success is a 77% protection rate.

What we don’t know, and might learn in a few hours, is whether the first interim analysis came and went. If it did, that would mean the vaccine was less than 77% effective, which could be a bad sign going forward. It would also dim any hopes of getting definitive data before 2021. If it hasn’t, you can bet analysts are going to come up with dozens of variations of “So, when then?” in hopes that Pfizer offers a clue.

You can tune in here.

Lilly’s Covid-19 antibody doesn’t work in hospitalized patients

Eli Lilly and the NIH stopped a clinical trial of the company’s anti-Covid-19 antibody treatment after concluding that patients in the study weren’t benefitting from it.

The trial, which the NIH paused earlier this month, had enrolled about 300 patients who were hospitalized with Covid-19. In an earlier study, a combination of two Lilly antibodies looked effective in patients with mild Covid-19 who didn’t require hospitalization. That trial, along with two others enrolling non-hospitalized patients, is still ongoing. Lilly has already filed for an emergency use authorization from the FDA.

The discontinued study adds to a growing body of evidence that antibodies — whether engineered in a lab or delivered through the blood plasma of a recovered patient — are most effective in the early stages of Covid-19 and may offer little benefit to people whose disease has progressed. Regeneron Pharmaceuticals, which is developing an antibody combination of its own, demonstrated some positive results for early-stage patients in September.

The congressional campaign where drug pricing is issue No. 1, 2, and 3

The rising cost of medicine is one of those fabled bipartisan, kitchen-table issues you hear about on TV, and it reliably pops up in speeches and pamphlets of countless candidates. But in the race for Minnesota’s 8th congressional district, Quinn Nystrom has made drug pricing the overarching theme of her entire campaign.

As STAT’s Nicholas Florko reports, Nystrom is a 34-year-old with Type 1 diabetes whose political career began when Pete Stauber, the Republican incumbent, broke his promise to hold a town hall on insulin affordability in their district. In the months since, she’s pilloried Stauber for voting against drug pricing legislation and led three pilgrimages to Canada to buy cheaper insulin.

Her odds of victory, according to FiveThirtyEight, are quite long, and outside experts question whether a candidate running on a single issue can win a federal office. Nystrom, for her part, takes that as a compliment. “That’s what they have on me?” she said. “I think that’s a reason for people to vote for me —  because I’ve committed my life to helping people afford health care.”

Read more.

Here comes another Covid-19 IPO

The Covid-19 crisis has had a dramatic effect on biotech company valuations, a phenomenon handily explained by CureVac, a company developing a vaccine for the novel coronavirus. On Aug. 14, the German firm priced its IPO at $16 a share. By Aug. 17, it was worth nearly $80 a share, a five-fold return over the course of a weekend.

Atea Pharmaceuticals will hope for a similar market reaction when it goes public later this month. The company, which is developing an antiviral treatment for Covid-19, is planning to raise more than $250 million in an IPO, aiming to price its shares between $20 and $22 each. 

The drug, AT-527, is an oral treatment designed to block a virus’s ability to replicate. It was invented to treat hepatitis C, but Atea pivoted once the pandemic set in. AT-527 in a Phase 2 study involving about 190 patients with mild Covid-19 and one or more risk factors for bad outcomes, and Atea expects to have interim safety data before the end of the year. 

A well-traveled drug target embarks on its ninth life

There’s an enzyme in the body that regulates what scientists refer to as “the bliss molecule,” a neurotransmitter associated with generally feeling good. And thus it made sense that blocking that enzyme, called FAAH, might be a useful way to combat feeling bad, like in cases of chronic pain or depression. And so a bunch of drug companies fashioned FAAH inhibitors and tested them in dozens of trials, only for each one to prove too weak or too toxic to become an actual medicine. This lasted until around 2015, when the industry seemed to just move on from FAAH.

With all that in mind, yesterday’s news that Jazz Pharmaceuticals bought the rights to an FAAH drug previously sidelined by Pfizer was surprising. It’s a small expenditure, with just $35 million changing hands up front, but it stands out considering FAAH has been, as SVB Leerink analyst Ami Fadia put it in a note to investors, “a drug development graveyard.”

Jazz’s newly acquired FAAH inhibitor comes from SpringWorks Therapeutics, which spun out from Pfizer in 2017, and is being studied as a treatment for PTSD. It makes sense on paper, as EvercoreISI analyst Umer Raffat noted: An earlier study found that the drug led to a 10-fold increase in the aforementioned bliss molecule, and there’s data suggesting people with PTSD have reduced levels of the same neurotransmitter. Whether that means Jazz can succeed where Merck, Johnson & Johnson, Eli Lilly, and others gave up remains to be seen.

More reads

  • At the top of her field, a Covid-19 researcher fights back against a different kind of virus: sexism and power imbalances in science. (STAT)
  • Second Brazilian company to produce Russia's Sputnik V Covid-19 vaccine. (Reuters)
  • Biogen chair Stelios Papadopoulos takes his investing experience to the SPAC party. (Endpoints)

Thanks for reading! Until tomorrow,

Tuesday, October 27, 2020


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