Lilly's pivotal Alzheimer's data are robust

Eli Lilly's experimental Alzheimer's drug slowed cognitive and functional decline in patients by an impressive 35% compared placebo, data released this morning show, further validating the beta amyloid approach that's been the linchpin of research into the neurodegenerative disease.

The results should bolster Lilly's plan to secure FDA approval for donanemab, which would pit it against Eisai's and Biogen's Alzheimer's drug lecanemab. A Phase 3 study of lecanemab, or Leqembi, showed a 27% slowing of Alzheimer's progression.

"If I had taken a blank piece of paper and predicted the results, I might not have been as bold as to predict this kind of outcome, which perfectly validates the science and also sets a new benchmark for what's possible in treating Alzheimer's," Eli Lilly's chief scientific officer, Daniel Skovronsky, told STAT. "No one's seen numbers like this ever before in an Alzheimer's trial."

Importantly, two patients and possibly a third died from brain swelling that's common to plaque-clearing drugs like donanemab, lecanemab, and their controversial predecessor, aducanumab. The results of the study were released in a press release, but haven't yet been reviewed by outside scientists.

Skovronsky will join STAT's Breakthrough Summit in San Francisco later today to discuss the new data.

succession

A new CEO to replace Tony Coles at Cerevel

Neuroscience-focused Cerevel Therapeutics announced this morning that it's naming Bain Capital partner Ron Renaud as its new CEO. He'll succeed storied biotech vet Tony Coles, who has helmed the Pfizer spinout since 2019, and will continue on as chairman of the board.

Cerevel, a Bain portfolio company, has raised $1.5 billion in capital and now trades publicly. Renaud previously led another biotech — the mRNA-focused Translate Bio — until it was snapped by up Sanofi in 2021 for $3.2 billion.

Among Cerevel's lead programs are emraclidine, an experimental drug in mid-stage trials for schizophrenia and Alzheimer's disease psychosis. Another is darigabat, which is being tested for epilepsy and panic disorder. The company's approach is to target neurocircuitry in the brain, using different mechanisms to try and tweak neural networks gone awry in brain disorders.

scuttlebutt

A gabfest with gallows humor

At a biotech panel at the Milken Institute Global Conference in Los Angeles yesterday, industry executives lamented the brutal shifts that have led to sell-offs in recent months.

Perhaps it was gallows humor, but the audience (including many investors) erupted in laughter at this exchange: "I think you're going to see a lot of the cash given back,'' said Jim Tananbaum, founder and CEO of Foresite Capital Management. To that, moderator Lisa Suennen of Venture Valkyrie Consulting jumped in, "At gunpoint?''

After the laughs subsided, Tanenbaum said of investors: "They want their money back.... There's also a lot of tired venture capitals who live in 10-year venture funds, and you're seeing a lot of activists in the field right now.'' He added, "the venture model is not well-suited for drug development.''

Yet the panelists said they remained hopeful. Christopher Austin, CEO of Vesalius Therapeutics, a Flagship Ventures company, said of overfunded companies, "There's never a bad time to do good medicine, science value creation — but you have to think about where the puck is going to be.'' Asked what he thought the number one target for investment should be, he laughed, "It's a rogues gallery,'' but went on to cite chronic kidney disease, congestive heart failure, and schizophrenia.

Clinical trials

Making clinical trials more accessible

The FDA is leaning into a decentralized clinical trial approach, saying that it'd be beneficial to test drugs, biologics, and devices in places that aren't your standard clinical trial site, according to new draft guidance. It's often difficult to maintain continuity in clinical trials, since participants drop out frequently when it's too onerous to continue. The hope is that these DCTs "increase the breadth and diversity of participants in clinical trials," regulators say.

To help retain volunteers, the agency has a number of suggestions — such as conducting lab tests for trial participants at nearby hospital or clinics, rather than requiring them to schlep all the way to the research centers. And regulators say that clinical follow-up visits could be done via telemedicine or at home.

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