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A failure for a Roche Alzheimer's drug, Covid vaccines for kids, & green shoots for biotech stocks

 

The Readout

Good morning, everyone. Damian here with news from the latest prevention trial in Alzheimer's disease, some welcome news for biotech companies, and the end of a long wait for Covid-19 vaccines.

An ambitious Alzheimer’s study fails

A study testing whether a Roche treatment can prevent cognitive decline in patients destined to get Alzheimer’s disease failed, the company said today, ending a long and ambitious effort to help people with a rare and devastating genetic mutation.

As STAT's Adam Feuerstein reports, the trial found no significant difference between placebo and crenezumab, an antibody treatment targeting toxic plaques called beta amyloid. Roche, working with the Banner Alzheimer’s Institute and the National Institute on Aging, enrolled about 250 people who carry a genetic mutation that guarantees they will develop Alzheimer’s in the first five decades of life, giving them crenezumab or placebo over the course of five to eight years.

The trial’s outcome should be little surprise to the Alzheimer’s field, as crenezumab had failed in two prior studies enrolling patients with early-stage disease. And amyloid-targeting Alzheimer’s therapies have consistently disappointed in large-scale clinical trials over the last decade, including Biogen’s Aduhelm, the first and only one to win FDA approval.

Read more.

Good news still makes money in biotech

As recently as 2021, biotech companies seldom waited more than 12 hours after disclosing good news in order to raise money through a stock sale. After a year of declining valuations and clinical disappointments, good news has been rare, and such follow-on offerings have virtually dried up.

But it’s not impossible to turn positive data into cash. Yesterday, Day One Biopharmaceuticals raised $150 million by selling shares at $15 apiece, news that came two days after the company disclosed promising early results for its lead cancer treatment. Cogent Biosciences, whose share price rose nearly 80% on positive Phase 2 data last week, raised $150 million of its own four days later.

In a biotech market nearly devoid of positive signs, this probably counts as one. If all this happened two years ago, Day One and Cogent would likely have met with much larger price bumps in response to their data, allowing them to raise more money by selling less stock. But now it’s 2022, and companies will take what they can get.

Covid vaccines for kids are nigh

FDA advisers voted unanimously in favor of authorizing the Pfizer-BioNTech and Moderna Covid-19 vaccines for kids as young as six months, signaling the end of a long wait for parents around the country.

STAT’s Helen Branswell and Matthew Herper endured the day-long meeting, where, despite the unanimous vote, panelists disagreed about just how great the need for pediatric Covid vaccines really is. One compared the risk of a child dying from Covid to a person being struck by lighting. Another described a packed children’s hospital during the Omicron surge. A third said he hopes every child gets vaccinated against Covid.

For parents who have long since made up their minds about vaccinating young children, the wait isn’t quite over. The FDA is widely expected to issue emergency authorizations for both vaccines in the coming days, but their wide availability will depend on an expert panel that advises the CDC, the Advisory Committee on Immunization Practices, which will meet Friday and Saturday.

Read more.

When will ‘real-world data’ live up to its promise?

Advances in technology have allowed researchers to gather terabytes of data from day-to-day life, outside of standardized clinical studies. Advances in analysis have revealed much of that data to be an uninterpretable mess. So how can one sift through suddenly abundant health information and isolate signals that might actually improve people’s lives?

STAT’s Jonathan Wosen asked Jessica Mega, co-founder and chief medical and scientific officer of Verily, the Alphabet spinout focused on health care. The key is having a clear question you’re trying to answer, “because you have to know what altitude you’re flying at to know what data to use,” Mega said. 

She thinks about so-called real-world data in two waves: information that can improve how existing treatments are used, and information that can light the way to medicines that don’t yet exist. The dream, Mega said, is to use technology “to close the loop between research and care,” using data to at once guide the treatment of disease but also develop the next therapy.

Read more.

More reads

  • Goldman backs biotech firm in volatile year for China deals. Bloomberg
  • Supreme Court sides with hospitals on Medicare drug pay dispute. STAT

Thanks for reading! Until tomorrow,

@damiangarde
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Thursday, June 16, 2022

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