COVID-19 Long Haulers: Real-Time Research Clarifying the Condition

 Dr. Steven Sheris, M.D., is president of the Atlantic Medical Group in Morristown, New Jersey, where his team has developed a concept for how to “co-exist with COVID”, and it includes a COVID recovery center to treat patients and conduct real-time research into the confusing condition. 

On a Monday appearance with the American Medical Association (AMA)’s Scott Unger, Sheris outlined his observations of the condition commonly called Long COVID-19, including the variability of the illness. 

“I don't think we saw a real good correlation between really the sickest patients and less sick patients with the acute illness who developed persistent symptoms. What I'm trying to explain is that you can have had a relatively mild illness, but it persisted for weeks and weeks with very specific symptoms or a symptom that was tough to tackle. Likewise, we had people in the ICU, spent a long time in the ICU, make a complete recovery and do very well, said Sheris, who is also an experienced cardiologist.

So, what is the solution to this complex challenge?

Real-Time Studies Defining Brain Fog

The landscape may begin to become clearer as real-time research continues to emerge about the long-term effects of COVID-19 infection. A large study published Tuesday in The Lancet Psychiatry assessed long haul patients within six months of diagnoses for the incidence of 14 neurological and psychiatric conditions including ischemic stroke, psychotic mood, anxiety disorders and substance abuse.

Among the 236,379 post-COVID-19 patients, 1 in 3 were diagnosed with a neuropsychiatric condition within the next six months, most commonly mood disorders, and 12.8% of those were first-time diagnoses of the illness. In fact, compared to the control groups, first-ever diagnoses were nearly twice as high. Potentially more concerning was the fact that these diagnoses included dementia and stroke. 

“We need urgent research to better understand how and why does this occur in patients with Covid-19 and how they can be treated and [how to] prevent it. But we think that regardless of the explanation, health services need to be prepared for the increased demand that this data is showing,” said Max Taquet, a clinical fellow in psychiatry at the University of Oxford and co-author of the study.

A smaller study published recently in the Annals of Clinical and Translational Neurology found that a whopping 85% of non-hospitalized long COVID patients experienced at least four lasting neurological issues. This research, conducted by Northwestern Medicine in Chicago, is based on an analysis of 100 COVID-19 long haulers with symptoms persisting at least six weeks.

Vaccines Offer Hope for Long Haulers

Scientists are trying out a new name for these long COVID symptoms, dubbing them “Post-Acute Sequelae of Covid-19”, or PASC, and they may be a little bit closer to understanding the condition suffered by COVID-19 survivors as patients are reporting some relief after receiving their first vaccination. 

Survivor Corps, a patient advocacy group started by long-haulers, found that 41% out of 900 people surveyed reported anywhere from slight-to-full recovery after being inoculated.

Yale immunologist Akiko Iwasaki poised two theories. One, the vaccines are helping to clear the “viral reservoir”, or the remnants of the virus in the body.

“That’s probably the most straightforward way. If that’s the case, people will be cured of long COVID and that will be wonderful news,” Iwasaki said.

 Less optimistically, Iwasaki said that the shots may be providing temporary relief from an autoimmune response triggered by COVID-19. 

Either way, Survivor Corps and Iwasaki, who are in collaboration on a study to analyze the blood samples of long haulers before and after vaccination, have reason to hope. 

“I have received numerous emails and DMs on Twitter about patient experiences ... and I’m hearing every day from people who are feeling better from getting the vaccine. From where I stand, it looks encouraging,” Iwasaki shared.

A Video Game Cure for Brain Fog?

Can Akili Interactive Labs treat ADHD and long haul COVID?

After making history last year with EndeavorRx (AKL-T01), which won U.S. Federal Drug Administration (FDA) approval last summer for the treatment of kids with ADHD, the digital medicine and video game developer plans to see if the game can work its magic for long haulers suffering from a symptom known as brain fog.

The company will conduct two randomized remote studies, one by Weill Cornell Medicine and New York-Presbyterian, the other by Vanderbilt University Medical Center, to determine whether AKL-T01 can help to improve cognition for long term COVID-19 patients.

Akili is seeking to prove the value of EndeavorRx in more therapeutic areas.

“The technology that we have at Akili is not very specific to one disease area. It basically improves attention control, which is one of the aspects of cognition, and that is part and parcel of many different disorders,” said Akili chief medical officer, Anil S. Jina. 

In a study of 57 patients in rehab after COVID-19 hospitalization conducted by Cornell, preliminary data showed that 81% of patients had some cognitive impairment, with 55% experiencing deficits in working memory, and 46% divided attention.

Jina added that small independent studies have also demonstrated the potential of EndeavorRx in dementia and cognitive impairment.  

https://www.biospace.com/article/covid-19-long-haulers-real-time-research-clarifying-the-condition/

Walgreens-backed VillageMD eyes IPO

 VillageMD, a primary health-care provider backed by Walgreens Boots Alliance Inc., is planning to go public in the U.S. in an initial public offering, according to people with knowledge of the matter.

The company, founded in 2013, plans to raise more than $500 million in a listing that could happen in the third quarter, the people said, asking not to be identified because the information is private. The IPO could raise as much as $1 billion and value the company at up to $10 billion, one of the people said.

Health-care and health-tech deals have fared well despite market volatility in the past year as the global pandemic lured more investments into the sector. Another primary-care service provider, Agilon Health Inc., filed on Wednesday to raise as much as $1.1 billion in a U.S. IPO. Two of the four blank-check mergers announced this week involve health-care companies.

A representative for VillageMD didn’t immediately respond to a request for comment.

VillageMD operates its own clinics under the brand name Village Medical and also partners with independent providers, according to its website. Some of its offices are located inside Walgreens stores under a partnership with the drugstore chain.

The company, which operates in 12 U.S. markets, raised $100 million in 2019in a series B financing round from Swedish investor Kinnevik AB, Oak HC/FT, Town Hall Ventures and Adams Street Partners, according to a company statement at the time.

Kinnevik valued its 9% stake in the company at 4.84 billion Swedish kronor ($561 million) as of Dec. 31, according to a filing. That implies a current valuation of $6.2 billion for VillageMD.

https://www.bloomberg.com/news/articles/2021-04-07/walgreens-backed-villagemd-said-to-plan-initial-public-offering

J&J backed by US C of C, PhRMA and more in SCOTUS appeal of $2.1B talc verdict

 Johnson & Johnson has gained major support in its quest to challenge a $2.1 billion verdict over claims that its talc-based powders cause cancer. 

The U.S. Chamber of Commerce and other business groups on Monday pressed the Supreme Court to review the verdict, taking aim at the merging of 22 plaintiffs' cases and the damages J&J was subsequently asked to shell out. 

In a 2018 trial, a Missouri jury ordered Johnson & Johnson to pay $4.69 billion after hearing the combined claims of 22 women who alleged the company’s talc powder caused their ovarian cancer. Last summer, the Missouri Court of Appeals for the Eastern District knocked the verdict down to $2.1 billion.

After J&J failed to overturn the verdict on appeal, it elected to take the issue up with the Supreme Court. The verdict has climbed to $2.5 billion with interest, J&J said in a recent annual SEC filing.

Amassing nearly two-dozen plaintiff testimonies into a single case put J&J at a severe disadvantage because it lent undue emotional weight to the proceedings and stripped the company of its ability to address claims on a case-by-case basis, the business groups wrote in a petition to the high court. 

To hear the petitioners tell it, jurors were subjected to an "emotional barrage" as plaintiffs or their surviving family members detailed their cancer struggles. Each of those plaintiffs placed blame squarely on Johnson & Johnson's products, which could have jeopardized the jury's ability to make an objective decision, they wrote.

"Worse still, that repetition appears to generate evidence of causation by creating a false cohort of individuals who appear to share only two things: product use and disease," the petitioners said.

J&J, for its part, wrote in its own petition to the Supreme Court that the Missouri verdict was "at odds with decades of independent scientific evaluations confirming Johnson’s Baby Powder is safe, is not contaminated by asbestos and does not cause cancer." The company also cited "numerous legal errors" and a "faulty" presentation of the facts in its petition.

In the 2018 trial, the court found plaintiffs had "proved with convincing clarity that defendants engaged in outrageous conduct because of an evil motive or reckless indifference." 

Still, it's far from certain the Supreme Court will take up the case. Of the 7,000 cases it's asked to review each year, the high court takes up 100 to 150 of them, according to U.S. government figures.

Plaintiffs' attorney Kevin Parker in November said the appellate court had "carefully considered the instructions and verdict rendered at the trial court, and the resulting opinion presented a fair and reasonable resolution of the claims." He urged J&J to accept the verdict move forward with compensation.

Meanwhile, J&J still faces around 25,000 talc lawsuits, the drugmaker disclosed in an annual SEC filing in February. 

https://www.fiercepharma.com/pharma/j-j-gets-chamber-commerce-business-groups-backing-2-1b-talc-verdict-appeal

Ionis lays off majority of Akcea staff, expands Sobi Tegsedi deal

 After taking Akcea inhouse last year, Ionis Pharmaceuticals is laying off 70% of the staff.

The move comes as Ionis expands an earlier deal with Swedish Orphan Biovitrum (Sobi) to now distribute rare disease med Tegsedi in North America. Ionis had already struck a deal in December with Sobi to distribute Akcea’s Tegsedi and Waylivra in Europe.

The layoffs primarily affect Akcea’s Tegsedi field team and support staff, Ionis reported in an SEC filing. Akcea retains marketing duties for Tegsedi in the U.S. and Canada and will continue to lead Tegdesi’s global commercial strategy.

Ionis called the plan a reorganization of Akcea’s workforce “to better align with immediate needs of its business.” Akcea will focus on next-generation “high priority programs,” including its proprietary ligand conjugated antisense (LICA) IONIS-TTR-LRx, Ionis added.

Akcea employed about 300 people; those affected were notified on Monday. No executive announcements were made, but, former Akcea CEO Damien McDevitt had already left the company in January, joining Aspen Neuroscience as president and CEO.

The FDA approved Tegsedi in 2018 to treat ATTR polyneuropathy, but sales have been lower than expected. Ionis reported $70 million in combined sales of Tegsedi and Waylivra in 2020; it continued to make the bulk of its revenue from Spinraza royalties at $287 million. Tegsedi's competitor, Alnylam’s Onpattro, reported much higher sales of $306 million in 2020.

Tegsedi, along with others in the ATTR therapy market, was negatively affected by COVID-19, with fewer new diagnoses last year. SVB Leerink lowered sales expectations for the drug for 2020 from $158 million to $118 million and predicted “lower market share in 2021 and beyond” for the product.

Tegsedi still fell short of that revised estimate. Onpattro, however—for which SVB Leerink lowered its sales target to $298 million because of the pandemic—exceeded it.

https://www.fiercepharma.com/marketing/ionis-lays-off-majority-akcea-staff-expands-deal-sobi-for-tegsedi

PRA remote patient monitoring platform selected by Merck for human growth hormone

 PRA’s cloud-based infrastructure enables Merck KGaA, Darmstadt, Germany to deliver a better product experience and scale for future enhancements

PRA Health Sciences (NASDAQ: PRAH) announced today that Merck KGaA, Darmstadt, Germany, known in the United States as EMD Serono, selected PRA’s remote patient monitoring platform to work in combination with its human growth hormone (HGH) treatment system. Under this agreement, PRA’s remote patient monitoring platform backs Merck KGaA, Darmstadt, Germany’s HGH treatment system, including growlinkTM, a mobile app for patients prescribed with HGH treatment, and easypod® Connect, a secure platform for healthcare professionals (HCP) in the field of endocrinology to monitor patients’ adherence, review injection history, and share information about patients’ progression with growth hormone disorder.

Human growth hormone treatments are frequently prescribed for children and adolescents with growth hormone deficiency, a condition that impacts approximately 1:4,000 to 1:10,000 children¹ each year in the U.S. Despite the prevalence of growth hormone deficiency and treatment options, one of the biggest challenges is ensuring patients’ adherence to the regimen. Adding this layer of technology to HGH treatments better facilitates patient engagement, helps HCPs make better use of patient visits, and ensures the treatment is taken regularly and at the right dosage, optimizing treatment outcome and driving payer confidence.

https://finance.yahoo.com/news/pra-remote-patient-monitoring-platform-200100629.html

U.S. begins study on allergic reaction risk in Moderna, Pfizer vaccines

 The U.S. National Institutes of Health said on Wednesday it had begun a mid-stage study to determine the risk of allergic reactions to COVID-19 vaccines made by Moderna Inc and Pfizer Inc.

Several allergic reaction incidents, including serious episodes, known as anaphylaxis, have been reported in the U.S. after vaccinations of Pfizer/BioNTech and Moderna shots.

In January, the U.S. Centers for Disease Control and Prevention said allergic reactions are occurring at a rate of 11.1 per 1 million vaccinations.

The study, funded by the National Institute of Allergy and Infectious Diseases, will enroll 3,400 adults between the ages of 18 to 69, with about 60% participants having a history of severe allergic reactions to food, insect stings or immunotherapy.

The goal of the trial is to access the proportion of participants who have a systemic allergic reaction within 90 minutes after injection.

The agency expects to report data later this summer.

https://www.reuters.com/article/us-health-coronavirus-vaccines-allergies/u-s-begins-study-on-allergic-reaction-risk-in-moderna-pfizer-vaccines-idUSKBN2BU20I

UK variant of COVID-19 is now most common strain in US: CDC

 The highly contagious variant of COVID-19 first discovered in the United Kingdom has become the most common strain of the virus in the United States as cases continue to climb, a top U.S. health official said on Wednesday.

The strain, known as B.1.1.7, was identified in Britain last fall and has since been detected in 52 jurisdictions in the United States, U.S. Centers for Disease Control and Prevention Director Dr. Rochelle Walensky told reporters at a White House briefing.

U.S. public health officials have urged Americans to get vaccinated as soon as possible in part to prevent new variants of the novel coronavirus from spreading.

The United States has also detected cases of a variant first discovered in South Africa that is thought to be resistant to some COVID-19 vaccines and treatments. That strain has been found in 36 U.S. jurisdictions, according to federal data last updated on Tuesday.

The United States is administering about 3 million COVID-19 vaccine doses per day on average over the past week, up 8% over the previous seven-day average, Walensky said.

Vaccine supply has increased significantly in the United States in recent weeks as Johnson & Johnson has begun making millions of doses of its recently authorized shots. Pfizer/BioNTech and Moderna have also recently boosted their vaccine production capacity.

U.S. President Joe Biden has doubled his goal for shots administered in his first 100 days in office from 100 million to 200 million and urged states to begin giving shots to all adults by mid-April.

Still, daily U.S. cases of novel coronavirus are averaging 63,000 over the past seven days, up 2.3% from the previous seven-day average, Walensky said.

Walensky said that the CDC has identified a number of COVID-19 outbreaks tied to youth sporting events and that communities experiencing high case counts should avoid holding such events. Testing should also happen twice a week, she said.

White House COVID-19 adviser Andy Slavitt also told reporters that the U.S. government is expanding its community health center program, which it set up in recent weeks to help get vaccines into underserved communities.

https://www.reuters.com/article/us-health-coronavirus-usa-whitehouse/uk-variant-of-covid-19-is-now-most-common-strain-in-united-states-cdc-idUSKBN2BU29X