Cerevel Gets FDA Fast-Track Designation for CVL-871 in Dementia-Related Apathy

 Cerevel Therapeutics Holdings Inc. on Tuesday said the U.S. Food and Drug Administration granted fast-track designation to CVL-871, in development for the treatment of dementia-related apathy.

The Cambridge, Mass., company, which is focused on neuroscience diseases, said it plans to initiate screening in a Phase 2a exploratory trial in dementia-related apathy in the next few weeks, with data expected in the second half of 2022.

The FDA's fast-track program is designed to facilitate the development and expedite the review of treatments for serious or potentially life-threatening illnesses with high unmet medical needs.

Cerevel said CVL-871 could be a potential treatment to address the symptoms represented by dementia-related apathy, such as social disengagement, diminished initiative and interest, and loss of emotion.

https://www.marketscreener.com/quote/stock/CEREVEL-THERAPEUTICS-HOLD-110370301/news/Cerevel-Gets-FDA-Fast-Track-Designation-for-CVL-871-in-Dementia-Related-Apathy-35609937/

Novavax unveils phase 3 COVID jab data, but has it missed the boat in US?

 The top-line phase 3 data for Novavax’ COVID-19 vaccine look good, with a 90% overall efficacy rate, but a dip in its share price indicates investors fear it could be too late for the programme.

Novavax’ price spiked 9% after the data were announced today, but fell back just as quickly, despite the company’s assertions that it should now be in a position to file for emergency use authorisation (EUA) of NVX-CoV2373 in the third quarter.

Novavax said last month it would have to delay the completion of filings in the US, UK and Europe, originally scheduled for this month, because there was still work to be done on the chemistry, manufacturing and controls (CMC) data that would be needed for an EUA.

Given the positive results – which also showed suggested the shot was 100% effective at preventing moderate-to-severe COVID-19 and had 93% efficacy against variants of concern – it seems there are some doubts about its long-term prospects as cases decline and supplies of already-approved vaccines firm up.

Shareholders may also have the jitters because another late-stage COVID-19 vaccine developer – Ocugen – was told by the FDA it would have to file for full approval rather than going down the speedier EUA route, becoming the first drugmaker to be affected by the regulator’s stricter stance on emergency approvals.

AstraZeneca meanwhile has already said that it may forego the EUA approach for its AZD1222 vaccine and go straight for a full marketing application.

“Novavax continues to work with a sense of urgency to complete our regulatory submissions and deliver this vaccine, built on a well understood and proven platform, to a world that is still in great need of vaccines,” said the company’s chief executive Stanley Erck.

He told a conference call today that it may well be that in the US NVX-CoV2373 is used primarily in booster programmes.

Novavax’ phase 3 PREVENT-19 trial was conducted in 30,000 patients in the US and Mexico, with 63 cases of COVID-19 in the placebo group compared to 14 of the vaccine arm. That’s in line with an ex-US study that generated results in March.

By sequencing virus from COVID-19 cases seen among patients in the trial, the Maryland-based biotech said the shot seemed to have good efficacy against the alpha or B.1.1.7 variant first identified in the UK, as well as other variants of concern including the beta (B.1.351) strain that emerged in South Africa.

It is also testing another version of the vaccine that has shown stronger immune responses against beta and other variants and could also be used as a booster shot.

The UK has ordered 60 million doses of NVX-CoV2373 and a further 1.1 billion doses are due to go to the COVAX programme, which distributes vaccines to poorer countries.

Novavax said it remains on track to reach manufacturing capacity of 100 million doses per month by the end of the third quarter of this year, and 150 million doses per month by the end of the fourth quarter.

The vaccine is based on a protein subunit that mimics the spike protein on SARS-CoV-2 and can be stored at regular refrigeration temperatures.

https://pharmaphorum.com/news/novavax-unveils-phase-3-covid-jab-data-but-has-it-missed-the-boat-in-us/

Healthcare manager Bright Health Group sets terms for $1.3 billion IPO

 Bright Health Group, which provides health insurance and other healthcare services, announced terms for its IPO on Tuesday.

The Minneapolis, MN-based company plans to raise $1.3 billion by offering 60 million shares at a price range of $20 to $23. At the midpoint of the proposed range, Bright Health Group would command a fully diluted market value of $15.4 billion.

Bright Health Group seeks to employ a more consumer-centric approach to healthcare than legacy healthcare management organizations to improve consumer experiences. The core Bright HealthCare business has grown to serve roughly 623,000 patients in 14 states in the five years since its founding. The company's newest offering, NeueHealth, uses technology to connect healthcare providers and payors and maintained nearly 75,000 unique patient relationships as of April 2021.

Bright Health Group was founded in 2015 and booked $1.9 billion in sales for the 12 months ended March 31, 2021. It plans to list on the NYSE under the symbol BHG. J.P. Morgan, Goldman Sachs, Morgan Stanley, Barclays, BofA Securities, Citi, and Piper Sandler are the joint bookrunners on the deal. It is expected to price during the week of June 21, 2021.

Relevant Profile: BHG

https://www.renaissancecapital.com/IPO-Center/News/82782/Healthcare-manager-Bright-Health-Group-sets-terms-for-$1.3-billion-IPO

Life sciences-focused SPAC JATT Acquisition files for a $120 million IPO

 JATT Acquisition, a blank check company targeting life sciences technology, filed on Tuesday with the SEC to raise up to $120 million in an initial public offering.

The Cayman Islands-based company plans to raise $120 million by offering 12 million units at $10 per unit. Each unit contains one share of common stock and one-half of a warrant, exercisable at $11.50. At the proposed deal size, the company would command a market value of $150 million. 

JATT Acquisition is led by CEO and Chairman Someit Sidhu, co-founder and CEO of Akaza Bioscience and Izana Bioscience and co-founder of Pathios Therapeutics, and CFO Verender Badial, founder and Managing Director of Cryfield Investments. The company aims to leverage management's experience to target life sciences companies applying cutting edge technologies to the therapeutic development process, such as machine learning, artificial intelligence, mechanistic genetics, and structure-based drug design.

The company was founded in 2021 and plans to list on the NYSE under the symbol JATT.U. Raymond James is the sole bookrunner on the deal.

Relevant Profile: JATT.U

https://www.renaissancecapital.com/IPO-Center/News/82796/Life-sciences-focused-SPAC-JATT-Acquisition-files-for-a-$120-million-IPO

CDC issues alert about respiratory syncytial virus spread in Southern U.S.

 The Southern part of the United States is seeing an unusual late spring wave of respiratory syncytial virus (RSV) infections and health care providers should be on alert, the U.S. Centers for Disease Control and Prevention warned Thursday.

The recent spread of the virus has occurred in Alabama, Florida, Georgia, Kentucky, Mississippi, North Carolina, South Carolina, Tennessee, Arkansas, Louisiana, New Mexico, Oklahoma, and Texas.

"Due to this increased activity, CDC encourages broader testing for RSV among patients presenting with acute respiratory illness who test negative for severe acute respiratory syndrome coronavirus 2, the virus that causes COVID-19," the CDC alert advised.

"RSV is the most common cause of bronchiolitis and pneumonia in children under 1 year of age in the United States. Infants, young children, and older adults with chronic medical conditions are at risk of severe disease from RSV infection," the agency said. "Each year in the United States, RSV leads to on average approximately 58,000 hospitalizations with 100 to 500 deaths among children younger than 5 years old and 177,000 hospitalizations with 14,000 deaths among adults aged 65 years or older."

The CDC also warned that due "to reduced circulation of RSV during the winter months of 2020 to 2021, older infants and toddlers might now be at increased risk of severe RSV-associated illness since they have likely not had typical levels of exposure to RSV during the past 15 months."

https://medicalxpress.com/news/2021-06-cdc-issues-respiratory-syncytial-virus.html

A fifth of asymptomatic COVID patients develop long COVID: study

 Almost a fifth of COVID patients without symptoms went on to experience conditions consistent with long COVID a month after their initial diagnosis, according to a huge study published Tuesday.

The analysis by non-profit FAIR Health encompassed insurance claims from 1.96 million Americans—the largest population of patients ever studied for long COVID—from February 2020 to February 2021.

"Even as the COVID-19 pandemic wanes, long-haul COVID persists as a public health issue affecting many Americans," said FAIR Health's president Robin Gelburd.

"The findings in our new study shed significant light on this emerging issue for all individuals who have long-haul COVID, as well as for policy makers, providers, payors and researchers."

Perils of 'Long COVID'

"Long COVID" refers to symptoms of the disease that persist more than four weeks after being diagnosed.

The study found that across all ages, the most common post viral conditions were in order of frequency: pain, breathing difficulties, high cholesterol, general discomfort and fatigue, and high blood pressure.

The odds of dying 30 days or more after initially being diagnosed with COVID were 46 times higher for patients who were hospitalized with COVID and discharged compared to those who weren't hospitalized.

Overall, 0.5 percent of COVID patients who were hospitalized then discharged died 30 days or more after their initial diagnosis.

Nineteen percent of asymptomatic COVID patients experienced long COVID symptoms 30 days out from their initial diagnosis; the figure grew to 27.5 percent of COVID patients who were symptomatic but not hospitalized, and 50 percent of those who were hospitalized.

The order of most common long COVID conditions varied by age group—for example in the pediatric population, intestinal issues replaced high cholesterol as the third most frequent.

Most long COVID conditions were associated more with females than males—but some, such as cardiac inflammation, were more common in males, who accounted for 52 percent of cases against 48 percent for females.

A quarter of all such cases occurred among individuals aged 19-29.

Among the four mental health conditions evaluated after 30 days, anxiety was the most common, followed by depression, adjustment disorders and tic disorder.

The biggest drawback of the new study is it lacks a control group of people who never got COVID, which would help determine the extent to which COVID caused the conditions as opposed to being coincidental.

The causes of long COVID, which is also known as long haul COVID, post-COVID syndrome or post-acute sequelae of COVID, remain unknown.

"Theories include persistent immune activation after the acute phase; initial damage from the virus, such as damage to nerve pathways, that is slow to heal; and persistent presence of low-level virus," the study said.

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Explore further

Factors tied to severe COVID-19 in children identified

https://medicalxpress.com/news/2021-06-asymptomatic-covid-patients.html

COVID-19: Scientists discover source of life-threatening blood clots

 Scientists in Ireland have identified how some COVID-19 patients can develop life-threatening clots. The researchers said the findings could lead to therapies that prevent it from happening.

The work, led by researchers from RCSI University of Medicine and Health Sciences, is published in the Journal of Thrombosis and Haemostasis.

Previous research has established that blood clotting is a significant cause of death in patients with COVID-19.

To understand why clotting happens, the researchers analysed blood samples that were taken from patients with COVID-19 in the Beaumont Hospital Intensive Care Unit in Dublin.

They found that the balance between a protein that causes clotting, called von Willebrand Factor (VWF), and its regulator, called ADAMTS13, is severely disrupted in patients with severe COVID-19. When compared to control groups, the blood of COVID-19 patients had higher levels of the pro-clotting VWF molecules and lower levels of the anti-clotting ADAMTS13.

The researchers also identified other changes in proteins that caused the reduction of ADAMTS13.

Dr Jamie O’Sullivan, the study’s author and research lecturer within the Irish Centre for Vascular Biology at RCSI, said that the research helps provide insights into the mechanisms that cause severe blood clots in patients with COVID-19. It is critical to developing more effective treatments, she said.

“We looked at the markers in the blood of these patients and tried to understand what was underpinning the blood clotting,” said O’Sullivan. “We observed elevated levels of the protein, VWF.

“This is large, sticky adhesive-like protein that helps to bind platelets within the blood. It prevents people from bleeding excessively. We saw in patients with COVID-19 it was really elevated, five to six fold above normal levels.

“Then we looked at why the levels are so elevated and could we reduce it or use it as a therapeutic for patients.

“We also have this parallel of a reduced level of another protein or enzyme in the blood that would usually help to regulate blood clotting, know as ADAMTS13. We see that level of this anti-clotting are low in the blood of patients with COVID-19 creating a perfect storm for clotting complications in patients with severe infection.

“While more research is needed to determine whether targets aimed at correcting the levels of ADAMTS13 and VWF may be a successful therapeutic intervention, it is important that we continue to develop therapies for patients with COVID-19.

“It’s very much in its infancy and to the best of my knowledge it’s something being researched.”

O’Sullivan added: “COVID-19 vaccines will continue to be unavailable to many people throughout the world, and it is important that we provide effective treatments to them and to those with breakthrough infections.”

This work was funded by Irish COVID-19 Vasculopathy Study (ICVS) through the Health Research Board COVID-19 Rapid Response award as well as a philanthropic grant from the 3M Foundation to RCSI University of Medicine and Health Sciences in support of COVID-19 research.

The research was also led by Professor James O’Donnell of the RCSI and their clinical colleagues in Beaumont Hospital.

https://www.sciencefocus.com/news/covid-19-scientists-discover-source-of-life-threatening-blood-clots/