Drugmakers Regeneron Pharmaceuticals Inc. and Sanofi SA are racing to
launch clinical trials exploring whether their arthritis drug could
treat symptoms of novel coronavirus infections.
The study preparations mark the latest effort in an emerging front in
researchers’ hunt for effective treatments for Covid-19, the
respiratory disease caused by the novel coronavirus. In the U.S., there
aren’t any drugs or vaccines approved for the condition.
The research aims to see whether certain drugs already on the market
to tackle immune disorders like rheumatoid arthritis could help ease
damage to the lungs and respiratory system caused by the immune system’s
overreaction to the virus causing Covid-19. The drugs wouldn’t treat
the underlying virus.
The research aims to see whether certain drugs already on the market
to tackle immune disorders like rheumatoid arthritis could help ease
damage to the lungs and respiratory system caused by the immune system’s
overreaction to the Covid-19 virus, rather than killing it.
The Sanofi and Regeneron drug, called Kevzara, was approved by the
Food and Drug Administration in 2017 to treat rheumatoid arthritis.
“The goal would be in the next couple of weeks to have the trial up
and running, and in weeks to months after that to have the data,”
Regeneron Chief Scientific Officer George Yancopoulos said in an
interview on Tuesday.
Boosting the rationale for studying Kevzara’s effect on Covid-19 was a
recent report by Chinese researchers that a similar-acting drug,
Actemra from Roche Holding AG, had helped a small group of patients with
severe or critical Covid-19 disease recover.
Several patients in the study “got out of death’s bed and walked out
of the hospital” after receiving Actemra, Dr. Yancopoulos said. However,
he cautioned that the study required repeating because it was small,
not controlled and didn’t have defined parameters for success.
Genentech, a Roche subsidiary, said it is exploring opportunities to
conduct U.S. studies of Actemra in Covid-19 patients with pneumonia,
said a company spokeswoman. A study of the drug on Covid-19 was recently
begun by the First People’s Hospital of University of Science and
Technology of China, she said.
Both Actemra and Kevzara block proteins called interleukin-6, or
IL-6, that trigger the body’s immune and inflammatory response. Normally
the response helps fight infections. If the immune system overreacts,
however, it can attack healthy tissue and organs.
In some novel coronavirus patients, the immune response may be
accelerating and damaging the lungs even after significantly diminishing
the amount of virus in the body, said Naimish Patel, Sanofi’s head of
global development for immunology and inflammation, in an interview.
Blocking IL-6 may put the brakes on the immune system and keep the body from attacking itself, he said.
“Even though the virus is diminishing, it’s sending signals to the
immune system to keep attacking,” said Dr. Patel. “If there’s too much
inflammation, you end up killing cells that aren’t infected and leading
to more damage than you really need.”
Symptoms associated with Covid-19 include fever, low oxygen levels in the blood and difficulty breathing.
One concern about deploying drugs that dampen the immune system is
that patients could become more prone to infection, said Timothy
Sheahan, assistant professor of epidemiology at the University of North
Carolina, who conducts laboratory research into drugs for coronaviruses,
including Gilead Sciences Inc.’s remdesivir.
Several drugmakers in addition to Gilead are looking for drugs aiming
to cure novel coronavirus infections, while Sanofi and other companies
are working on vaccines to prevent the infections.
Regeneron is leading efforts to study Kevzara in the U.S. and is in
talks with the FDA, New York state Health Commissioner Howard Zucker and
hospitals designated to care for Covid-19 patients and could serve as
research sites for the trial, Dr. Yancopoulos said. The study would
evaluate the drug only in patients with severe to critical disease.
The company, based in Tarrytown, N.Y., is likely to kick off the trial in New York, he said.
The FDA didn’t immediately respond to requests for comment. Dr. Zucker didn’t immediately respond to a request for comment.
Sanofi, based in Paris, is responsible for studying the drug in
Covid-19 overseas and hopes to begin studies as soon as possible,
perhaps in weeks, Dr. Patel said.
“Given the quickly evolving situation around Covid-19, we are working
to leverage the knowledge of both companies in evaluating how Kevzara
may be a potential treatment option for some patients,” a Sanofi
spokeswoman said.
Regeneron and Sanofi co-developed Kevzara as part of a yearslong
R&D collaboration. In December, the companies said that as part of a
restructuring of the collaboration, Sanofi will take full ownership of
the drug. But the restructuring terms aren’t final yet and could change
and the companies are actively discussing how the drug’s potential
treating Covid-19 may factor into the completed pact, a Sanofi
spokeswoman said.
Dr. Yancopoulos said the companies jointly decided that Regeneron
would lead the U.S. research program in Covid-19 “because it’s the right
thing to do,” and they will figure out the details later.
Separately, Regeneron is developing new antibody drugs to kill the
virus itself and aims to have the drugs ready to study in humans by the
end of August, the company has said.
https://www.marketscreener.com/REGENERON-PHARMACEUTICALS-10649/news/Regeneron-Pharmaceuticals-Sanofi-to-Test-Arthritis-Drug-as-Coronavirus-Treatment-2nd-Update-30139963/
Tuesday, March 10, 2020
NY to close schools, houses of worship in suburban center of coronavirus outbreak
Schools, houses of worship and large gathering venues in part of the New York City suburb of New Rochelle will shut down for two weeks in an effort to contain the coronavirus outbreak at its local epicentre, Governor Andrew Cuomo said on Tuesday.
The shutdown, which begins on Thursday and is due to last until at
least March 25, affects an area of New Rochelle in Westchester County
that measures 1 mile (1.61 km) in diameter. The county accounts for more
than 100 of the state’s 173 confirmed cases, the governor said.
“This will be a period of disruption for the local community,” Cuomo said at a news conference. “It is a dramatic action, but it is the largest cluster in the country. And this is literally a matter of life and death.”
Cuomo said he was calling in the National Guard to the containment area to assist with cleaning public spaces and to deliver food to homes.
New Rochelle Mayor Noam Bramson said the National Guard would ensure that students who rely on school meals would receive food but would “not have a military or policing function.”
“It is very important to clarify that this is not an exclusion or quarantine zone. No one is prohibited from entering or leaving the area,” the mayor said at a news conference after the governor’s announcement.
The number of cases of the highly contagious respiratory illness caused by the virus has risen steadily to more than 800 in the United States. There have been 28 deaths, most of them in Washington state, according to a tally by Johns Hopkins University. New Jersey on Tuesday reported the state’s first death.
The containment measure will close three public schools and several parochial and private schools, in addition to houses of worship, country clubs, and possibly other public places, Bramson said.
New Rochelle’s senior center, which is outside the containment zone, will also be closed until further notice to prevent spread of the disease among one of the most vulnerable groups, the mayor said.
Coronavirus deaths have disproportionately hit the elderly with the largest U.S. cluster at a nursing home near Seattle.
Bramson said his office was still consulting with state authorities to create a comprehensive list of businesses and facilities that would be affected.
The group of cases in Westchester County emerged after an attorney who lives in New Rochelle and works in Manhattan became the second person in New York to be diagnosed with the virus last week.
Some cases in the town have been traced to the Young Israel Synagogue of New Rochelle, where the attorney attended services last month. The synagogue, which public health officials closed last week, is at the center of the containment zone.
“The heaviest burdens have fallen upon the members of Young Israel,” Bramson said. “Many are quarantined, which is enormously disruptive to their daily lives, and yet there has been a sense of commitment to the common good.”
New York State Health Commissioner Howard Zucker said in a statement on Tuesday that he believed the risk generally to people in New York remained low, and Cuomo urged New Yorkers not to panic.
“If you are not a member of the vulnerable population then there is no reason for excess anxiety,” Cuomo said.
“This will be a period of disruption for the local community,” Cuomo said at a news conference. “It is a dramatic action, but it is the largest cluster in the country. And this is literally a matter of life and death.”
Cuomo said he was calling in the National Guard to the containment area to assist with cleaning public spaces and to deliver food to homes.
New Rochelle Mayor Noam Bramson said the National Guard would ensure that students who rely on school meals would receive food but would “not have a military or policing function.”
“It is very important to clarify that this is not an exclusion or quarantine zone. No one is prohibited from entering or leaving the area,” the mayor said at a news conference after the governor’s announcement.
The number of cases of the highly contagious respiratory illness caused by the virus has risen steadily to more than 800 in the United States. There have been 28 deaths, most of them in Washington state, according to a tally by Johns Hopkins University. New Jersey on Tuesday reported the state’s first death.
The containment measure will close three public schools and several parochial and private schools, in addition to houses of worship, country clubs, and possibly other public places, Bramson said.
New Rochelle’s senior center, which is outside the containment zone, will also be closed until further notice to prevent spread of the disease among one of the most vulnerable groups, the mayor said.
Coronavirus deaths have disproportionately hit the elderly with the largest U.S. cluster at a nursing home near Seattle.
Bramson said his office was still consulting with state authorities to create a comprehensive list of businesses and facilities that would be affected.
The group of cases in Westchester County emerged after an attorney who lives in New Rochelle and works in Manhattan became the second person in New York to be diagnosed with the virus last week.
Some cases in the town have been traced to the Young Israel Synagogue of New Rochelle, where the attorney attended services last month. The synagogue, which public health officials closed last week, is at the center of the containment zone.
“The heaviest burdens have fallen upon the members of Young Israel,” Bramson said. “Many are quarantined, which is enormously disruptive to their daily lives, and yet there has been a sense of commitment to the common good.”
New York State Health Commissioner Howard Zucker said in a statement on Tuesday that he believed the risk generally to people in New York remained low, and Cuomo urged New Yorkers not to panic.
“If you are not a member of the vulnerable population then there is no reason for excess anxiety,” Cuomo said.
https://www.marketscreener.com/news/New-York-to-close-schools-houses-of-worship-in-suburban-centre-of-coronavirus-outbreak–30140033/
Sanders cancels Cleveland rally over coronavirus concerns
U.S. Democratic presidential candidate Bernie Sanders has cancelled a rally set for Tuesday night in Cleveland over concerns about holding large public gatherings during the coronavirus outbreak, his campaign spokesman said.
“Out of concern for public health and safety, we are cancelling
tonight’s rally in Cleveland,” spokesman Mike Casca said in a statement.
“We are heeding the public warnings from Ohio state officials, who have communicated concern about holding large, indoor events during the coronavirus outbreak,” he said. “All future Bernie 2020 events will be evaluated on a case by case basis.”
“We are heeding the public warnings from Ohio state officials, who have communicated concern about holding large, indoor events during the coronavirus outbreak,” he said. “All future Bernie 2020 events will be evaluated on a case by case basis.”
https://www.marketscreener.com/news/Bernie-Sanders-cancels-Cleveland-rally-over-coronavirus-concerns–30140031/
Generic anti-malarial may treat COVID-19 – Raymond James
A generic drug used to treat malaria may be as
promising as any that companies are currently scrambling for to treat
COVID-19, the coronavirus-related disease spreading rapidly, Raymond
James says.
Analyst Steven Seedhouse says chloroquine – a
longtime oral anti-malarial that costs pennies per dose – could turn out
“more effective, scalable, and affordable” than the candidates being
studied by companies including AbbVie (NYSE:ABBV), Gilead (NASDAQ:GILD), and Regeneron (NASDAQ:REGN), not to mention Moderna (NASDAQ:MRNA), GlaxoSmithKline (NYSE:GSK), Pfizer (NYSE:PFE) and others.
After very early indications of efficacy in China,
chloroquine is seeing increased demand suggesting it may be seeing
real-world use already, though ultimate efficacy depends on data that
still need to be gathered.
https://seekingalpha.com/news/3550389-generic-anti-malarial-may-treat-covidminus-19-raymond-jamesGT Biopharma up 20% on plan for coronavirus treatment
Thinly traded nano cap GT Biopharma (OTCQB:GTBP +20%) is, yet another, would-be player in the rush to develop a drug to treat COVID-19.
This morning, it announced a
collaboration agreement with contract development and manufacturing
services provider Cytovance Biologics aimed at advancing a TriKE
candidate for severe acute respiratory syndrome associated with
SARS-CoV-2 infection, the coronavirus causing the current outbreak.
Under the terms of the deal, the companies will
focus on producing enough product for preclinical studies using
Cytovance’s E. coli-based Keystone Expression System. Production will be
scaled up with Cytovance’s GMP microbial manufacturing platform for
human trials.
TriKEs
(Tri-specific NK cell Engager) are small single-chain fusion proteins
that bind to a certain receptor on natural killer (NK) cells, eliciting a
more durable and potent immune response. GT’s first TriKE candidate
was GTB-3550 for the potential treatment of acute myeloid leukemia (AML).
https://seekingalpha.com/news/3550190-gt-biopharma-up-20-on-plan-for-coronavirus-treatmentGilead’s Descovy shows long-term effectiveness in HIV PrEP study
Longer-term data from the Phase 3 DISCOVER study evaluating Gilead Sciences’ (GILD -5.2%)
Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets,
F/TAF) for preexposure prophylaxis (PrEP) to reduce the risk of sexually
acquired HIV-1 infection in at-risk adult men and transgender women
showed a favorable safety profile and non-inferior efficacy compared to
Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg,
F/TDF). The results were presented at the Conference on Retroviruses and
Opportunistic Infections in Boston.
At week 96, participants receiving Descovy continued to show beneficial changes in key biomarkers of renal and bone safety.
Descovy’s non-inferiority to Truvada was
demonstrated in the overall study population as well as subpopulations
of participants older than 50 and younger than 25. A separate analysis
showed that both drugs were effective and well-tolerated in Black and
Hispanic/Latinx subjects.
The FDA approved Descovy in October 2019 for HIV PrEP.
https://seekingalpha.com/news/3550202-gileads-descovy-shows-long-term-effectiveness-in-hiv-prep-studyTeladoc up 6% on insurance coverage of telemedicine
Teladoc (TDOC +6.2%) perks up on 22% higher volume on the heels of an announcement from Vice President Mike Pence that health insurers will pay for telemedicine services during the COVID-19 outbreak.
The company is top dog in the space, completing
~4.1M telehealth visits last year. It says it has over 36.7M U.S.
members and 19.3M visit fee-only users, delivering services in more than
175 countries around the world.
https://seekingalpha.com/news/3550209-teladoc-up-6-on-insurance-coverage-of-telemedicine
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