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The Readout Damian Garde & Meghana Keshavan

Pfizer and the mysteriously timed vaccine data

As you probably assumed from the absence of push notifications and text messages, Pfizer did not announce world-changing results from its Covid-19 vaccine study yesterday. Instead, over the course of an hour-long cat-and-mouse conference call, the company that once forecast results as early as October explained that we’ll get data when data are good and ready.

As STAT’s Matthew Herper reports, the big reveal yesterday was that Pfizer’s ongoing trial hasn’t had its first data check-in, which is scheduled to take place after there have been 32 confirmed cases of Covid-19 among volunteers, whether in the placebo group or the vaccine group. In a sense this is good news: If that check-in had come and gone with no announcement, it would mean the vaccine is less than 77% effective, as dictated by the trial design. The fact that it hasn’t happened yet means there’s still hope Pfizer’s vaccine will show an early sign of strong efficacy.

All that being said, however, the fact that there haven’t yet been 32 cases in the trial suggests volunteers are coming down with Covid-19 at a slower rate than Pfizer had initially modeled, which implies that it might take longer to reach that first check-in than the world would prefer. Adding the confusion is the fact that Pfizer plans to make a public statement only if the interim look at data is “conclusive,” CEO Albert Bourla said, meaning the 32nd case could come and go with none of us the wiser.

Read more.

Sometimes drug development isn’t as complicated as it looks

Earlier this week, a company called Catabasis Pharma disclosed that, despite its best efforts, an investigational treatment for Duchenne muscular dystrophy did not beat placebo in a pivotal clinical trial. As STAT’s Adam Feuerstein points out, that should not have come as a surprise to anyone, because Catabasis had demonstrated that its drug didn’t work three years ago.

Back in 2017, the company enrolled 30 patients with DMD in a randomized, double-blind study comparing its drug to placebo. After 12 weeks, Catabasis ran a full slate of muscle function tests. The result: No difference between edasalonexent or a placebo.

And yet the company persisted, drawing up plans for a Phase 3 trial because, as Feuerstein writes, “it had nothing but someone else’s money to lose.” Which brings us back to 2020, when that study, like the one before it, found Catabasis’s drug had no benefit for patients with DMD.

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There’s money in liquid biopsy

The diagnostics firm Exact Sciences signed a $2.2 billion deal to buy Thrive Earlier Detection, a liquid biopsy firm, marking the second 10-figure acquisition in the space this year.

As STAT’s Kate Sheridan reports, the deal works out to $1.7 billion in cash and stock with another $450 million tied to future milestones. Thrive’s liquid biopsy is intended to screen healthy people for one of several types of cancer, many of which do not already have easy screening options. Data presented in April struck outside experts as encouraging.

The merger comes about a month after Illumina agreed to pay $8 billion for Grail, a liquid biopsy firm the company spun out five years before.

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Covid-19 has micro-cap biotechs spending money on lobbyists

Spending big money on Washington lobbying firms is general the purview of giant pharmaceutical companies, which have products to promote and budgets to underwrite more than a few K Street meals. But the Covid-19 crisis has brought some unlikely political entities into the fold: small-time biotech companies still in the clinical stage.

As STAT’s Nicholas Florko reports, the likes of Arcturus Therapeutics, Athersys, and Humanigen have spent thousands of dollars to lobby on behalf of their investigational medicines for Covid-19. 

Perhaps most interesting is EmitBio, a company developing what it describes as a light therapy for Covid-19, which retained the lobbying firm Fidelis Government Relations. The company’s website touts explains that “a new world is here,” and “we are ready to protect it” with “carefully selected wavelengths of light can be deployed for bodily defense to eliminate invading pathogens.”

Read more.

More reads

  • In a pivotal race in North Carolina, Democrats try to paint the incumbent as ‘pharma’s favorite senator.’ (STAT)
  • Supply chains will become more local in the pharmaceutical industry, says healthcare CEO. (CNBC)
  • Philippines' Duterte wants government-to-government deal for COVID-19 vaccines. (Reuters)
  • Can boosting the ‘bliss molecule’ help treat mental health conditions? An oft-failed idea gets another shot. (STAT Plus)

Thanks for reading! Until tomorrow,

Wednesday, October 28, 2020


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