The Alzheimer’s treatments of the future

Jun 27, 2023

Driving The Day

An Alzheimer’s affected brain, with abnormal levels of the beta-amyloid protein clumping together, is pictured.

Some pharma companies are moving away from developing drugs targeting amyloid and looking for other methods to treat Alzheimer's. | AP Photo/Courtesy of the National Institute on Aging/NIH

AIMING BEYOND AMYLOID — The FDA is expected to grant full approval to Leqembi, an Alzheimer’s drug from Eisai and Biogen. But drugmakers are already eyeing the field’s future.

For decades, the therapeutic pipeline has been dominated by large pharmaceutical companies focused on addressing the misshapen proteins called amyloid, which some scientists believe is one cause of the disease.

But now, the first two treatments to address amyloid, Leqembi and Aduhelm, appear to only modestly slow the disease with risks of severe side effects. And with Medicare’s unwavering decision to limit coverage, most of the estimated 100,000 patients eligible to take the drugs have been unable to get them. Even with traditional approval, Eisai estimates that only 10,000 patients will receive the drug by April 2024.

But as new research about the disease has unfolded, drugmakers large and small are turning their focus to other targets, Katherine reports. The treatments won’t make it to the market for a few years, but clinicians hope the drugs will eventually make up a robust treatment landscape.

Some of those treatments go after tau, a protein also thought to contribute to cognitive decline. Tangles of tau often develop after patients develop clumps of amyloid, but they persist even after amyloid is removed. Some of these treatments in mid-stage trials aim to remove tau tangles, while others try to prevent the brain from producing the protein.

Other drug companies are focusing on the brain’s immune system. Some newer drugmakers, like the startup NeuroTherapia, think cognitive decline is related to inflammation. Other drugmakers, like the startup Alector, believe the immune system could be trained to more efficiently go after amyloid and tau.

And some researchers think existing treatments for other diseases could be repurposed. Scott Turner, director of the Memory Disorders Program at Georgetown University, told Katherine that he and his team are conducting clinical trials to see whether nicotine patches can help with some cognitive symptoms of Alzheimer’s.

Clinicians aren’t giving up on amyloid just yet, though. “It’s setting things in the right direction, but it’s not going to bring us all the way home,” Ronald Petersen, director of the Mayo Clinic’s Alzheimer's Disease Research Center, told Katherine.

Large drug companies, including Eli Lilly, Roche and Genentech, have anti-amyloid therapies in mid- to late-stage development. Lilly plans to ask the FDA to grant traditional approval for its anti-amyloid treatment, donanemab, later this year.

IT'S TUESDAY. WELCOME TO PRESCRIPTION PULSE. The House and the Senate may be out until July 7, but we know there’s never a dull moment in this field.

Send news and tips to David Lim (dlim@politico.com or @davidalim) or Katherine Ellen Foley (kfoley@politico.com or @katherineefoley).

TODAY ON OUR PULSE CHECK PODCAST, your host Ben Leonard talks with Erin Schumaker, who provides insight into the future of psychedelic drug research and development now that the FDA has issued its first draft guidance for designing clinical trials using the drugs.

Listen to today’s Pulse Check podcast

MEDICAL DEVICES

A syringe is prepared

Ethylene oxide is used to sterilize many medical devices, including syringes. | Matt Rourke/AP Photo

INDUSTRY: EPA EtO PROPOSALS ‘CREATE SIGNIFICANT RISK’ — The two largest medical device lobbies are concerned about proposed rules that would cut emissions of a carcinogenic gas. The gas, called ethylene oxide, is used to sterilize about 50 percent of devices; lobbyists fear that, as written, the rules could cut in half the U.S.’ ability to sterilize these devices.

Manufacturers argue that lack of adequate sterilizing capacity would lead to shortages in medical devices needed for patient care.

“The medtech industry and EPA must continue working together to improve these two proposals because as written, we could see significant shortfalls and a risk to patient access,” AdvaMed CEO Scott Whitaker said in a statement.

In its comments submitted to the EPA, the Medical Device Manufacturers Association argued that the agency underestimated the costs that the proposed regulations would pose to medical device makers and patients.

“EPA must seriously consider how the social costs of its proposed regulatory actions may inadvertently lead patients to delay their medical procedures and screenings due to the lack of available and affordable medical devices,” MDMA CEO Mark Leahey wrote.

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Industry Intel

ILLUMINA ANNOUNCES LAYOFFS — Genomic sequencing giant Illumina said Monday it plans to cut $100 million in annual costs this year by cutting its workforce and reducing its real estate footprint.

The details, disclosed in an SEC filing, include exiting its San Diego i3 campus and evaluating “options” for its campus in Foster City, Calif.

Pharma Worldwide

GAVI AGAIN SEEKING TOP EXECUTIVE — Gavi, the Vaccine Alliance that was pivotal in delivering Covid-19 vaccines to the world’s poorest countries, is again searching for a new leader, POLITICO’s Carmen Paun reports.

Muhammad Ali Pate, a former Nigerian health minister and senior World Bank official, accepted the job in February to take over from current CEO Seth Berkley, who’s leaving after 12 years and two terms — the maximum allowed — at the top of the organization.

But Pate has decided against taking the job. He informed Gavi “that he has taken an incredibly difficult decision to accept a request to return and contribute to his home country, Nigeria,” the organization said Monday.

Coronavirus

CDC’S ADVISERS PONDER EVOLVING IMMUNITY DATA — On Friday, the CDC’s vaccine advisory committee heard presentations regarding the latest data on Covid-19 immunity ahead of potential fall boosters. The most recent federal data suggests that most healthy adults and children retain some forms of immunity against the virus even as strains continue to evolve, but older adults and those with compromised immune systems remain at risk for developing severe disease.

Those considerations may help the agency decide who may benefit from a fall booster now that the FDA has named the XBB.1.5 lineage of the Omicron variant a target for vaccine makers.

Speaking of boosters, Pfizer and BioNTech filed applications to the FDA late Friday for updated boosters. Moderna filed an application for its XBB.1.5 booster earlier last week.

Pharma Moves

Anthony Fauci, the former director of the National Institute of Allergy and Infectious Diseases and a leader of the country’s Covid- response, is joining Georgetown University as a university professor in the School of Medicine’s Division of Infectious Diseases.

What We're Reading

For POLITICO, Rachel Bluth, Maya Kaufman and Sejal Govindarao explain why Florida saw the biggest increase in abortions a year after the Dobbs decision.

A candidate weight-loss drug being developed by Eli Lilly, called retatrutide, helped cut body weight by 24 percent on average in a Phase II clinical trial, CNBC’s Berkeley Lovelace Jr. reports.

Pfizer’s new treatment for an autoimmune condition that leads to hair loss in teens offers hope to those who struggle with the social and emotional toll of the condition, Adrianna Rodriguez reports for USA Today.

Document Drawer

CMS released its end-stage renal disease prospective payment system proposed rule on Monday, which floats payment rate updates for treatment of people with acute kidney injury.

The FDA released draft guidance for drugmakers developing psychedelic drugs.

The FDA issued draft guidance outlining the formal dispute resolution process and the administrative hearing process for the Center for Drug Evaluation and Research for some over-the-counter monograph drugs.

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