A week about Alzheimer’s drug development

Good afternoon, readers.

The focus of today’s essay will not be COVID but about another horrible disease: Alzheimer’s.

It was an eventful week from both a drug development and research front on the memory-stealing ailment. Eli Lilly, one of the companies working on experimental treatments for Alzheimer’s, released additional data about its drug candidate donanemab, one of a slew of treatments in the works by pharmaceutical companies meant to attack amyloid plaque in the brain in order to halt the disease’s progression. That approach has led to multiple late-stage clinical failures, although firms such as Lilly and Biogen have continued to bet on it.

Investors were not impressed by Lilly’s results. The company’s shares dropped nearly 10% after the announcement on Monday, and are down more than 11% over the past five days. But Lilly executives urged caution and patience.

“I’m focused on the long-term future for Alzheimer’s patients,” said Dr. Daniel Skovronsky, the drug maker’s chief medical officer, in a conference call. “If you look at the data set … you see a package of results that are highly compelling that this will indeed become a medicine.”

Lilly says it can gain regulatory approval within the next two years by amassing more data in clinical trials. The mixed messages stem from mixed outcomes in the “endpoints” of the study data, the goals that a drug is supposed to achieve.

While the treatment did reduce amyloid plaque levels, which are associated with Alzheimer’s and dementia, other metrics on cognitive function weren’t quite that clear-cut.

And, yes, there is still a COVID tie-in showing how important these drug development efforts are. The pandemic fueled a 16% rise in Alzheimer’s related deaths as the risk for those most likely to have Alzheimer’s, when combined with the coronavirus, makes severe COVID illness far more likely.

We are all watching the vaccine effort, and for good reason. But other diseases need work, too.

Read on for the day’s news, and see you next week.

Sy Mukherjee
[email protected]
@the_sy_guy

DIGITAL HEALTH

Is Amazon's health care foray all hype? SVB Leerink analyst Stephanie Davis isn't mincing words about Amazon Care, part of the company's foray into digital health: It's much more bark than bite and won't prove to be a true disruptor in the space. In a research note sent to Coins2Day, Davis argues that Amazon is entering a space that is already crowded and filled with much more experienced players such as Teladoc and Amwell. Davis says Amazon's concentration on employers and not incorporating health care providers and insurers to the extent that other firms do could be a barrier to its growth. The basic message from the note is that name power isn't everything, even for a titan like Amazon.

INDICATIONS

mRNA drugs aren't always a success. Pfizer's and Moderna's COVID vaccines are based on mRNA technology, which instructs the body's cells to create certain biological products that can ward off the coronavirus. But it's easy to forget that, despite those products' remarkable success, mRNA technology is still pretty nascent and unproven in other disease spaces. Case in point: The failure of an mRNA-based drug from Translate Bio to improve the lung function of patients with the deadly and rare lung condition cystic fibrosis. The drug appeared to be safe in clinical trials. But when it comes to effectiveness? Not so much. The company says it will continue developing such products. (BioPharma Dive)

AstraZeneca COVID vaccine gets EU blessing. After a number of roadblocks, AstraZeneca and University of Oxford's jointly developed COVID vaccine has received recommendation from European health authorities. The European Medicines Agency concluded that it is safe and effective and that its benefits outweigh its risks after certain nations halted its use following reports of side effects such as blood clots. It could be a critical move in the innoculation campaign, which has lagged behind countries such as the United States, in Europe. (Coins2Day)

THE BIG PICTURE

Xavier Becerra confirmed as HHS secretary in razor thin vote. Former California Attorney General Xavier Becerra was confirmed as the next Secretary of Health and Human Services (HHS) by the Senate on Thursday. The vote passed by the narrowest of margins, with 50 in favor and 49 against, with just one GOP Senator, Maine's Susan Collins, joining Democrats to confirm him. Becerra will be taking on a critical role during a pandemic and has pledged to aggressively roll back Trump administration changes to the medical administrative state, including rules that roll back the health care safety net. He will also be the first ever Latino HHS Secretary during a time when the Latino community has been disproportionately affected by the COVID pandemic.