August 30, 2024

Here are the full results from Alnylam's HELIOS-B trial

After Alnylam in June released positive top-line results of its RNAi treatment vutrisiran in the heart condition ATTR-CM, its stock had surged over 70% as of yesterday's close. So investors expectations were high going into the full results of the trial, called HELIOS-B, presented today.

What do they show? We already knew that vutrisiran achieved the primary outcome, significantly cutting the risk of death or cardiovascular complications. The full data show that the drug began outperforming placebo on this endpoint about six months after the start of treatment, with the gap steadily growing over time.

Additionally, we saw all-cause mortality during the 36-month blinded portion of the study.

GLp-1s

Wegovy cut the risk of dying from Covid-19

Recall that last year, Novo Nordisk showed in a pivotal trial called SELECT that Wegovy cut the risk of cardiovascular complications. In further analysis of that trial, which was conducted during the pandemic, researchers have now found that Wegovy also cut the chances of dying from Covid-19 by roughly a third.

Given that obesity is a major risk factor for severe Covid outcomes, it may seem obvious that a drug that helps people lose weight also helps protect them from the worst of a SARS-CoV-2 infection. But researchers say it might not be as straightforward as that. Some studies have indicated that GLP-1 drugs like Wegovy bolster the immune system, tamp down inflammation, and strengthens other organs (including the liver and kidneys) in ways that scientists are only beginning to tease out.

more Glp-1s

New HFpEF analysis may support Wegovy label expansion

Another prominent Wegovy study at ESC was a new analysis that may boost Novo Nordisk's bid to expand the drug's label in heart failure with preserved ejection fraction (or HFpEF).

Researchers pooled together data on nearly 4,000 HFpEF patients across four trials and found that those treated with Wegovy had a 31% lower risk of cardiovascular-related death or heart failure events compared with those on placebo.

Novo had already shown in previous trials that Wegovy improved symptoms and physical function in HFpEF patients and had applied for a new indication. But earlier this month, Novo said it withdrew its application and would resubmit early next year with new data on outcomes such as death and hospitalizations, so that it could have stronger language in the label.

podcast

What's behind the abandonment of gene therapy R&D?

How does a startup spend $213 million? And is Adam Feuerstein an optimist?

We chat about all that and more on this week's episode of "The Readout LOUD." Our colleague Jonathan Wosen joins us to discuss gene therapy pioneer Jim Wilson's exit from his decades-long tenure at the University of Pennsylvania. We also talk about the latest news in the life sciences, including the surprising collapse of a gene editing company, Eli Lilly's pitch to consumers, and more.

Listen here.

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