Biogen Inc‘s Alzheimer‘s drug Aduhelm, approved by U.S. regulators last year for its ability to reduce amyloid brain plaques, also lowers levels of a second protein that accumulates in the brains of people with the disease, according to new data released by the company on Thursday.
Biogen said its Phase III studies found that Aduhelm significantly lowered blood levels of an abnormal form of the protein tau – another target of experimental Alzheimer’s drugs – that forms toxic tangles of nerve fibers associated with the mind-wasting disease.
The tau levels were correlated to changes in amyloid plaques and with slowing of cognitive and functional decline, the company said.
In one trial, tau levels in patients with early Alzheimer’s given the highest dose of Aduhelm fell 13%, compared with an increase of 8% for placebo patients. In the second trial, high-dose patients saw tau levels decrease 16%, while levels in the placebo group rose 9%.
“We now have robust and concordant data that Aduhelm has effect on two core defining pathologies of Alzheimer’s disease,” Biogen research chief Alfred Sandrock said in a statement.
The findings were presented on Thursday at the Clinical Trials on Alzheimer’s Disease conference held virtually and in Boston.
Since brain changes associated with Alzheimer’s, including amyloid and tau deposits, begin years before cognitive decline can be identified, drug development in recent years has focused on early treatment that can interfere with underlying changes believed to lead to the disease.
Only one of Biogen’s two pivotal trials showed Aduhelm can slow the rate of cognitive decline for Alzheimer’s patients. Many experts have questioned the Food and Drug Administration’s rationale for approving the drug without more definitive proof of benefit.
The FDA has defended its decision by saying there is clear evidence that Aduhelm removes amyloid from the brains of people with Alzheimer’s, arguing that the effect is reasonably likely to predict a clinical benefit to patients.
Some members of an advisory panel to the FDA resigned in protest and several prominent treatment centers have publicly said they will not offer Aduhelm to patients.
The new data shows that when the drug clears amyloid plaques it then impacts markers of neurologic degeneration, leading to improvements in clinical outcomes, Biogen Chief Medical Officer Maha Radhakrishnan said in an interview.
Early sales of Aduhelm, priced at $56,000-a-year, have been slow. Third-quarter sales of $300,000 were far below the nearly $11 million Wall Street had expected. Medicare, the government’s health plan for people over age 65, expects to issue a draft decision on its reimbursement policy – which will apply to all plaque-reducing agents – in January, with a final policy due in April.
In 2020, an estimated 5.8 million Americans aged 65 years or older had Alzheimer’s disease, according to the U.S. Centers for Disease Control and Prevention. This number is projected to nearly triple to 14 million people by 2060.
(Reporting By Deena Beasley; Editing by Bill Berkrot)
Omicron could threaten COVID-19 immunity — but we're not going back to 'square one' – CBC.ca
The omicron variant, now reported in multiple Canadian provinces and a growing number of countries worldwide, could threaten hard-won immunity to the virus behind COVID-19.
But global scientists say the world has a crucial head start on the latest variant of concern, thanks to early detection. And there’s hope this highly mutated version of the coronavirus won’t bring the world back to “square one” in this pandemic.
South African scientists quickly identified and alerted the world to the variant last week, finding a concerning number of mutations that could potentially impact the effectiveness of vaccines, the transmissibility of the virus and even the severity of disease.
Immunologists and virologists say that while it will still take time to determine the variant’s real-world impact, our immunity from vaccines and prior infection could take a significant hit if it takes off globally.
“I wouldn’t say that this one’s going to put us back to zero,” said Deepta Bhattacharya, an immunologist at the University of Arizona.
“But I do think that if it does spread, it’s going to be a bigger problem than any of the variants we’ve seen before.”
30+ mutations in spike protein
Omicron contains more than 30 mutations in just the spike protein, the part of the coronavirus which helps it enter human cells.
Bhattacharya said while the mutations in the virus are concerning, it’s important to keep in mind that the immune system is “multi-layered,” and that protection from vaccines and prior infection against severe disease will likely still hold up against the new variant.
“I think what we’ll see is, in all likelihood, a pretty big drop in how well antibodies work,” he said. “But then once we start to get some real-world studies into how things are doing, my guess is that the vaccines will still be doing a decent job in protecting people from getting really sick.”
Canada could actually be in a better position than other countries if omicron spreads more widely, Bhattacharya said, because our delayed second dose strategy provided “more optimal” immune protection in the population.
“What’s pretty clear is that that delayed spacing made a big difference in terms of antibodies and protection against delta — and I suspect it will be the same for omicron if it takes off,” he said.
“We’ve seen some other variants like this in the past that had us concerned — beta, I think, would be the best example — and it didn’t really take off. It basically just got creamed by delta. And I think we still don’t know the answer as to how this is going to go for omicron.”
Several leading vaccine manufacturers have announced they’re keeping a close eye on omicron and could have new vaccines ready in mere months, if needed.
Moderna’s CEO has also suggested that existing vaccines may be much less effective against the variant, though scientists are still waiting on hard data.
‘Worst features’ seen so far
Angela Rasmussen, a virologist at the Vaccine and Infectious Disease Organization (VIDO) at the University of Saskatchewan, said while previous variants have had similarly troubling characteristics, the real scientific concern with omicron isn’t just the number of its mutations, but where they are.
“Unfortunately, based on just the mutations, it looks like the omicron variant has some of the worst features of all of the variants of concern that we’ve seen thus far,” she said.
“But it’s also really important to note for people that we don’t know exactly what’s going to happen when all of these mutations get together, especially with all the other mutations that the omicron variant seems to have acquired.”
Some of omicron’s mutations have been associated with increased transmissibility, similar to alpha and delta, she said, while others have been associated with higher immune evasion, like with beta and gamma. And she notes delta has so far dominated all other variants.
“One of my biggest concerns is not so much that omicron is going to be more severe, but if omicron begins outcompeting delta,” Rasmussen said.
“Especially if it’s capable of causing more breakthrough infections that potentially could lead to another wave in many countries, particularly in the northern hemisphere, as we begin to go inside during the colder winter months and in preparation for the holidays.”
Precautions will likely still work against variant
But as speculation about the variant spreads quickly alongside rising case numbers, experts say it’s important to keep in mind that vaccines, public health restrictions and personal precautions will likely continue to work well to stop the spread of COVID-19.
“The key right now is we have to stick to the toolbox that we have developed over the last almost two years,” said Dr. Abraar Karan, an infectious diseases fellow at Stanford University in Stanford, Calif.
“The advantage that we have, any time we see a new variant, is we’re still dealing with SARS-CoV-2.”
If research confirms early signals that omicron is more transmissible, the usual principles still apply: It’s best to limit time in crowded indoor settings, and the use masking and increased ventilation to prevent the airborne spread of this virus.
“Don’t enter into a situation that is likely to be a danger for high transmission, meaning many unvaccinated people not wearing masks,” said Rasmussen.
With the holidays underway, Karan said it’s also crucial to layer precautions when gathering with family, like being fully vaccinated and adding in extra protections like mask-wearing — particularly around vulnerable groups who are at a higher risk of a serious infection.
“If you’re indoors, around a lot of people, you have to think: ‘Am I somebody, if I get COVID, is this very life-threatening for me?'” said Karan.
Wearing a high-quality mask, such as a KN95, would help stop aerosols or droplets from spreading, Karan noted, even if omicron proves more adept at latching onto human cells.
Unusual for variant to render vaccines ‘obsolete’
Multiple experts also agreed that what’s particularly crucial right now is for unvaccinated individuals to get their shots.
“At the individual level, if people are not yet vaccinated, they absolutely should get vaccinated,” said Dr. Isaac Bogoch, an infectious diseases physician.
There are also other ways to expand vaccination coverage, he said, including that children five and up are now eligible for inoculation, and the potential for booster eligibility to expand to more older adults.
Even if omicron is capable of evading some level of immunity from the current slate of vaccines and antivirals, which targeted the virus’s original strain, Rasmussen doesn’t expect the variant to fully reduce vaccine-based protection.
“Your immune system is composed of more than just neutralizing antibodies, and we do have other antiviral therapeutics that are in the pipeline,” she said. “So we’re not back to square one.”
Until we know more about what we’re up against, Bogoch said we can’t assume the worst.
“It would be extremely unusual for a variant to emerge that renders the protective benefit of vaccination completely obsolete,” he said.
“This may be chipping away at some of the protective immunity, and we’ll figure out if it does and to what extent in the days and weeks ahead. But some people are discussing that this is going to set us back to January of 2020 — and nothing could be further from the truth.”
Islander living with HIV for 3 decades reflects on World AIDS Day – CBC.ca
Troy Perrot-Sanderson has lived with human immunodeficiency virus for almost 30 years, but he’s only recently started talking about how he became infected.
“It’s a very difficult thing for me to talk about,” said Perrot-Sanderson, in an interview tied to Dec. 1, which is World AIDS Day. “I’ve only really started dealing with it.”
He said he was 21 years old when he was sexually assaulted, while he was living in Alberta.
After the rape, Perrot-Sanderson said his life “spiralled” as he used drugs and alcohol to cope.
He has just started to see a counsellor to help him deal with the trauma.
HIV, human immunodeficiency virus, attacks the body’s immune system. If HIV is not treated, it can lead to acquired immunodeficiency syndrome, or AIDS.
Perrot-Sanderson remembers that when he was first diagnosed, he thought his life was over. It took two decades after AIDS was first identified in the early 1980s to find an effective combination of drugs to treat it. In Canada alone, a 2017 report estimated, nearly 25,000 people had died of the disease by the end of 2016.
“I just slowly prepared myself to die for a few years,” Perrot-Sanderson said.
Advocate for others
He said he got more optimistic after he starting taking drugs to fight HIV. He volunteered and worked at AIDS PEI (later renamed PEERS Alliance) and was even acting executive director for a time.
“We can take medication and live a pretty normal life,” he said.
Of today’s PEERS leader, he added: “I can’t thank them enough. They’re doing all kinds of amazing work in the community.”
PEERS Alliance runs a number of education and outreach programs, working with a wide variety of people including gay and lesbian youth and adults; the trans community; and people who use drugs, who are susceptible to getting infected due to shared needles.
Still, as Perrot-Sanderson marks this World AIDS Day, he said it’s important to remember the people who have not survived, noting: “I have lost a lot of friends over the years.”
He worries there’s apathy around AIDS and HIV in 2021.
“A lot of people just don’t talk about it or think about it any more,” he said. “We know how to protect ourselves now — we certainly know so much more, we know how to prevent this disease.”
Hopes for the future
Josie Baker is the executive director of PEERS Alliance, and hopes people will take part in an open house set up to mark World AIDS Day.
Baker noted that there is better access to testing now, with at-home kits available for use “in the comfort of someone’s own home.”
Baker said non-nominal testing is also available, where each test is assigned a number instead of a name before going to the lab for analysis. That means people can be assured nobody at the lab will know who tested positive.
There are still pressing issues that require lobbying, though, 40 years after the HIV crisis began. Baker said having an HIV care specialist on P.E.I. would help, since many have to go off-Island for specialized care.
She also said being HIV-positive still carries a stigma on P.E.I. and elsewhere, and people should be able to access care and live in their communities free of judgment.
“That would be my hope: to end the stigma,” said Baker.
Perrot-Sanderson agrees, saying stigma often prevents people from seeking medical help.
“People ignore it and don’t protect themselves,” he said.
Singapore tests out ‘smart bandage’ for remote recovery
Researchers in Singapore have developed a smart bandage to enable patients to have chronic wounds monitored remotely via an app on a mobile device, potentially saving them visits to the doctor.
A research team at the National University of Singapore has created a wearable sensor attached to a transparent bandage to track progress in healing, using information like temperature, bacteria type, and levels of pH and inflammation.
“Traditionally when someone has a wound or ulcer, if it’s infected, the only way to examine it is through looking at the wound itself, through visual inspection,” said Chwee Teck Lim, lead researcher at the university’s department of biomedical engineering.
“If the clinician wants to have further information then they will obtain the wound fluid and send to the lab for further testing,” he said.
“So what we’re trying to do is use our smart bandage to cut the number of hours or days to just a few minutes.”
The “VeCare” technology will enable patients to convalesce more at home and visit a doctor only if necessary.
The bandage is being tested on patients with chronic venous ulcers, or leg ulcers caused by circulation problems in veins.
Data collection by researchers on the wounds has so far been effective, according to Lim, who said the smart bandage could potentially be used for other wounds, like diabetic foot ulcers.
(This story refiles to correct to cut extraneous word in the first paragraph)
(Reporting by Ying Shan Lee; Writing by Masako Iijima; Editing by Martin Petty, William Maclean)
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