Alzheimer’s Archives - Page 2 of 2 - Medical Design Sourcing

PurMinds believes psychedelics hold promise for neurological conditions

Interest in psychedelics has ratched up in recent years and a growing number of drug companies are beginning to explore their potential to treat everything from depression to neurodegeneration.

“It is a really really exciting time,” said Aron Buchman, chief strategy officer, PurMinds BioPharma, which is exploring psychedelics’ potential to treat neurological diseases.

American author Michael Pollan recently surmised in an interview with Independent that the psychedelics industry was in a “gold rush” phase. “Whether it’s going to work is another question. I think it’s going to be very challenging to fit into the system,” Pollan added.

Headquartered in North York, Ontario, PurMinds is based in a country that is warming up to the therapeutic potential of psychedelics. The Canadian government has granted a number of patients a federal dispensation covering the therapeutic use of p…

Why FDA’s approval of aducanumab was unprecedented

The backlash surrounding aducanumab post-approval has put Biogen (NSDQ:BIIB) on the defensive, prompting the company’s head of research and development, Dr. Alfred Sandrock, to post an open letter to the Alzheimer’s disease community on Biogen’s website. In the letter, Sandrock lamented that there was “extensive misinformation and misunderstanding” regarding the drug.

In recent weeks, the company also requested that the FDA narrow the indication for the drug to focus on Alzheimer’s patients with mild cognitive impairment or mild dementia. The FDA had initially indicated it for all Alzheimer’s patients even though clinical trials focused on patients with milder forms of the disease.

The collaboration between FDA staff and Biogen

FDA closely worked with Biogen during the approval process of aducanumab. Critics such as Public Citizen have called the cooperation between the two organizations “unprecedented” and “inappropriately close.”

FDA had viewed data fr…

FDA narrows indication of Biogen’s aducanumab

After FDA approved Biogen’s (NSDQ:BIIB) and Eisai’s (OTCMKTS:ESALY) Aduhelm (aducanumab) to treat Alzheimer’s disease, the agency faced criticism that the indication was overly broad. While initially indicating aducanumab for all Alzheimer’s patients, the agency has decided to recommend it for patients with mild forms of the disease.

The EMERGE and ENGAGE Phase 3 studies for the drug involved patients with early Alzheimer’s disease.

The revised label recommends the use of the drug in patients with “mild cognitive impairment or mild dementia stage of disease.”

The revised label points out that there are no safety or effectiveness data for people with “earlier or later stages of the disease than were studied” in the Phase 3 trials.

The update came after Biogen’s head of R&D, Dr. Alfred Sandrock, requested that the agency incorporate feedback from physicians and the Alzheimer’s community.

Critics have also lamented that the prospect of mak…

Lilly’s donanemab could outclass aducanumab, but questions remain

FDA’s approval of Biogen’s (NSDQ:BIIB) and Eisai’s (TYO:4523) Alzheimer’s drug aducanumab has resulted in significant gains in those companies’ shares.

But Lilly’s (NYSE:LLY) donanemab could be “perhaps better and cheaper,” concluded a recent investor note from Truist.

Lilly recently announced that it plans to file for accelerated approval for donanemab in the second half of 2021 under the accelerated approval pathway. As a result, Truist has pushed its launch assumption up two years to 2023 and raised its sales projections for the amyloid-plaque clearing drug.

Assuming the amyloid hypothesis is valid, donanemab holds promise as a potential disease-modifying therapy. In a Phase 2 trial, the investigational drug appeared to promote roughly twice the plaque clearance at 18 months as aducanumab did. Earlier studies also suggested that donanemab cleared plaque aggressively. The potential cognitive benefits of that clearance, however, remain unclear.

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Athira Pharma’s stock falls 39% after placing its CEO on leave

The Bothell, Wash.–based clinical-stage biopharma Athira Pharma (NSDQ:ATHA) is in a tailspin after the company’s board put Leen Kawas, the firm’s CEO, on temporary leave.

The company’s stock closed the day at an all-time low of $11.15. The stock was valued as high as $34.25 on Dec. 31, 2020.

Washington State University has launched an independent review of Kawas’s doctoral research in molecular pharmacology and toxicology, which she completed a decade ago.

The university is investigating reports that Kawas authored several papers with altered images.

Get the full story from our sister site, Drug Discovery & Development.

Three members of FDA advisory committee resign after aducanumab approval

FDA’s decision to conditionally approve Biogen’s Aduhelm (aducanumab) continues to cause controversy.

Three members of FDA’s Peripheral and Central Nervous System Drugs Advisory Committee have resigned. The most recent include David S. Knopman, a neurologist at the Mayo Clinic (Rochester, Minn.) and Aaron Kesselheim, a professor at Harvard University (Cambridge, Mass.)

Last November, eight committee members disagreed that there was sufficient clinical trial evidence to suggest that the drug was effective against Alzheimer’s. Another was undecided.

The first to resign was Joel Perlmutter, a neurologist at Washington University (St. Louis).

The three have not gone quietly.

In a letter to acting FDA Commissioner Janet Woodcock, Kesselheim called the aducanumab approval the “worst drug approval decision in recent U.S. history.”

Knopman told The Washington Post that he did not “wish to be part of a sham process.”

Perlmutter was mor…

Biogen’s stock pops nearly 40% after FDA’s Alzheimer drug approval, but questions remain

FDA has approved the Aduhelm (aducanumab) from Biogen, the first novel Alzheimer’s drug treatment, in 18 years despite drug companies pumping billions of dollars into more than 400 clinical trials.

The news caused Biogen’s share price to jump from $286.14 to $395.85 — a 38.34% increase.

It remains to be seen, however, just how big of a blockbuster Aduhelm will be. Some Alzheimer’s experts have stressed that they won’t prescribe aducanumab, citing a lack of convincing evidence that it is effective. Last November, an FDA advisory committee also expressed reservations about aducanumab’s clinical trial data. Three of those members explained their reasoning in a March editorial in JAMA.

But optimists stress that Aduhelm’s approval could also mark a turning point in treating Alzheimer’s disease (AD). “Aduhelm is the first therapy to target and affect the underlying disease process of AD,” said Alessio Brune…

Unraveling the promise of genetics for treating progressive illness

Image by Gerd Altmann from Pixabay

For almost every major common disease, researchers have less understanding of the severe forms than milder cases. And as a result, people with severe forms of diseases often have few treatment options available.

Thus, the significant unmet medical need for many diseases ranging from multiple sclerosis to Alzheimer’s is to halt disease progression and treat severe forms of the disease. “Most patients eventually do progress. We don’t understand what is causing that progression,” said Dr. Jeffrey Gulcher, chief scientific officer of Genuity Science (Boston).

What causes disease progression?

This basic concept concerning disease severity is evident in a range of clinical areas. Consider, for instance, non-alcoholic fatty liver disease, where abnormal amounts of fat are stored in the liver. Roughly one in four people in the U.S. have the condition, which can progress …