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Hydroxychloroquine is not effective when given late in mild-to-moderate COVID-19 patients, a new Brazilian study published in New England Journal of Medicine shows

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Everyone wants to “follow the science.” However, with coronavirus claiming over half a million lives around the world, doctors and scientists are experimenting with promising drugs that could potentially save patients’ lives. One  of these drug is malaria drug hydroxycholoroquine.

On March 30, FDA issued emergency use authorization of hydroxychloroquine before it was later withdrawn on June 15 due to health and safety risks. FDA said, “in light of ongoing serious cardiac adverse events and other serious side effects, the known and potential benefits of CQ and HCQ no longer outweigh the known and potential risks for the authorized use.”

We’ve been covering hydroxychloroquine for more than four months. On July 12, we wrote about another study from Henry Ford Health System that showed treatment with hydroxychloroquine cut the death rate significantly in sick patients hospitalized with COVID-19 – and without heart-related side-effects.

However, despite anecdotal evidence from doctors and physicians who credited hydroxycholoroquine for saving  patients’ lives, a new Brazilian study published in New England Journal of Medicine shows hydroxychloroquine is not effective when given late in mild-to-moderate COVID-19 patients.

According to NEJM, the research team conducted a three-group trial at 55 hospitals in Brazil. The trial included consecutive patients who were 18 years of age or older and who had been hospitalized with suspected or confirmed Covid-19 with 14 or fewer days since symptom onset.

However, the study did not provide detailed timeline of when the participants started the trial. Many front line doctors said hydroxychloroquine is effective only if the drug is taken early. For example, Dr. Harvey A. Risch, MD, PhD, a professor of epidemiology at Yale School of Public Health, said hydroxychloroquine has shown to be highly effective when the drug is given very early in the course of illness, especially when given in combination with the antibiotics azithromycin or doxycycline and the nutritional supplement zinc.

The trial was approved by the Brazilian National Commission for Research Ethics, the Brazilian Health Regulatory Agency (ANVISA), and ethics committees at the participating sites. The trial, which was funded by the hospitals and research institutes participating in Coalition Covid-19 Brazil,  found that among patients hospitalized with mild-to-moderate Covid-19, the use of hydroxychloroquine, alone or with azithromycin, c clinical status at 15 days as compared with standard care.

Below is the abstract of the study.

BACKGROUND
Hydroxychloroquine and azithromycin have been used to treat patients with coronavirus disease 2019 (Covid-19). However, evidence on the safety and efficacy of these therapies is limited.

METHODS
We conducted a multicenter, randomized, open-label, three-group, controlled trial involving hospitalized patients with suspected or confirmed Covid-19 who were receiving either no supplemental oxygen or a maximum of 4 liters per minute of supplemental oxygen. Patients were randomly assigned in a 1:1:1 ratio to receive standard care, standard care plus hydroxychloroquine at a dose of 400 mg twice daily, or standard care plus hydroxychloroquine at a dose of 400 mg twice daily plus azithromycin at a dose of 500 mg once daily for 7 days. The primary outcome was clinical status at 15 days as assessed with the use of a seven-level ordinal scale (with levels ranging from one to seven and higher scores indicating a worse condition) in the modified intention-to-treat population (patients with a confirmed diagnosis of Covid-19). Safety was also assessed.

RESULTS
A total of 667 patients underwent randomization; 504 patients had confirmed Covid-19 and were included in the modified intention-to-treat analysis. As compared with standard care, the proportional odds of having a higher score on the seven-point ordinal scale at 15 days was not affected by either hydroxychloroquine alone (odds ratio, 1.21; 95% confidence interval [CI], 0.69 to 2.11; P=1.00) or hydroxychloroquine plus azithromycin (odds ratio, 0.99; 95% CI, 0.57 to 1.73; P=1.00). Prolongation of the corrected QT interval and elevation of liver-enzyme levels were more frequent in patients receiving hydroxychloroquine, alone or with azithromycin, than in those who were not receiving either agent.

CONCLUSIONS
Among patients hospitalized with mild-to-moderate Covid-19, the use of hydroxychloroquine, alone or with azithromycin, did not improve clinical status at 15 days as compared with standard care. (Funded by the Coalition Covid-19 Brazil and EMS Pharma; ClinicalTrials.gov number, NCT04322123. opens in new tab.)


Source: https://techstartups.com/2020/07/28/a-new-brazilian-study-published-in-new-england-journal-of-medicine-shows-hydroxychloroquine-is-not-effective-when-given-late-in-mild-to-moderate-covid-19-patients/

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Sillicon Valley tech startup Atomwise scores $123 million for its AI drug discovery platform

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Researchers and companies struggle with access to AI-based drug discovery technology, due to overall cost and lack of expertise — something which requires computational scientists, drug discovery experts, software and systems engineers for AI and ML. Enter Atomwise, a San Francisco-based AI tech startup that is developing artificial intelligence systems using powerful deep learning algorithms and supercomputers for drug discovery.

Currently, Atomwise has provided AI technology to over 750 research collaborations addressing over 600 disease targets, and worked with top-pharmaceutical and biotechnology partners, to design new drugs for “undruggable” targets with speed and scale. We covered Atomwise back in March 2018 when the San Francisco-based AI tech startup raised $45 million for its AI-powered drug discovery platform.

Today, Atomwise announced it has raked in another $123 million Series B funding to focus on creating drugs for the vast number of genetic diseases that don’t have one yet. The oversubscribed round, which brings the total amount of capital raised to date to almost $175 million, was led by B Capital Group and Sanabil Investments.

The round also includes returning investors DCVC, BV, Tencent, Y Combinator, Dolby Family Ventures, AME Cloud Ventures, as well as new backing from two top ten global insurance companies. In conjuction with the funding, Atomwise also announced it has appointed Raj Ganguly of B Capital Group as a new board member and Hani Enaya of Sanabil as a board observer.

Atomwise also made the news in March 2017 after it identified medications that could reduce spread of the Ebola outbreak in West Africa. In medicine, identifying the right treatments for diseases normally takes years, it but took Atomwise only four months.

Founded in 2012 by Abraham Heifets, Alexander Levy, and Dr. Izhar Wallach, Atomwise invented the first deep learning AI technology for structure-based small molecule drug discovery. Today, Atomwise performs hundreds of projects per year in partnership with some of the world’s largest pharmaceutical and agrochemical companies, as well as more than 200 universities and hospitals in 40 countries.

AtomNet, its AI platform built for drug discovery contains more than 16 billion molecules for virtual screening. Atomwise has raised over $174 million from leading venture capital firms to support the development and application of its AI technology.

“Over the past three years, our platform AtomNet® has tackled — and succeeded — in finding small molecule hits for more undruggable targets than any other AI drug discovery platform,” said Abraham Heifets, CEO and co-founder of Atomwise. “With support from our new and existing investment partners, we will be able to leverage this to develop our own pipeline of small molecule drug programs, further grow our portfolio of joint-venture investments, and realize our vision to create better medicines that can improve the lives of billions of people.”

With the new investment, Atomwise will continue to scale its AI technology platform and team. The company plans to expand its work with corporate partners, which currently include major players in the biopharma space such as Eli Lilly and Company, Bayer, Hansoh Pharmaceuticals, and Bridge Biotherapeutics, as well as emerging biotechnology companies like StemoniX and SEngine Precision Medicine. Atomwise has signed more than $5.5 billion in total deal value with corporate partners to date.

The company will also leverage the financing to build its own internal pipeline tackling historically undruggable and other challenging disease targets. Atomwise will continue to grow its portfolio of joint ventures with leading researchers using AtomNet® for drug discovery, like those it has launched with X-37, Atropos Therapeutics, Theia Biosciences and vAIrus, with a goal to commercialize high potential candidates through the drug development process.

Atomwise created the first convolutional neural networks (CNN) for drug discovery, and since its founding in 2012 has continually developed and improved its AI-based drug discovery technology. The company’s AI technology has been used by academic researchers at institutes around the world and drug developers — including top-100 pharmaceutical and emerging biotechnology companies, a rapidly growing market estimated to reach $729B in global market value by 2025.


Source: https://techstartups.com/2020/08/11/sillicon-valley-tech-startup-atomwise-scores-123-million-ai-drug-discovery-platform/

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U.S. government reached a $1.5 billion deal with Moderna for 100 million doses of coronavirus vaccine

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Last month, we wrote about Moderna after the biotech giant announced it has begun the final-stage testing of its  coronavirus vaccine. Moderna said its mRNA vaccine could be ready for use by the end of 2020.

Today, the company received the good news from the U.S. Federal government. President Donald Trump announced Tuesday that the U.S. government has reached a deal to purchase 100 million doses of Moderna’s experimental coronavirus coronavirus mRNA vaccine, which is currently in late-stage human trials. President Trump made the announcement during a daily press conference at the White House.

“We are investing in the development and manufacture of the top six vaccine candidates to ensure rapid delivery. The military is ready to go, they’re ready to deliver a vaccine to Americans as soon as one is fully approved by the FDA and we’re very close to that approval,”  President Trump said.

In a separate announcement, Moderna said the deal for its mRNA vaccine vaccine is worth $1.525 billion. Under the terms of the agreement, the U.S. government, as a part of Operation Warp Speed, will also have the option to purchase up to an additional 400 million doses of mRNA-1273 from Moderna.

The U.S. government has announced that consistent with its commitment to free access to COVID-19 vaccines, Americans will receive mRNA-1273 at no cost for the vaccine itself. As is customary with government-purchased vaccines, healthcare professionals could charge for the cost of administering the vaccine. So far, the U.S. has already invested $955 million to develop Moderna’s vaccine, bringing its total investment up to $2.48 billion, the company said in a press release Tuesday.

Under the terms of the agreement, the U.S. government, as a part of Operation Warp Speed, will also have the option to purchase up to an additional 400 million doses of mRNA-1273 from Moderna. The U.S. government has announced that consistent with its commitment to free access to COVID-19 vaccines, Americans will receive mRNA-1273 at no cost for the vaccine itself. As is customary with government-purchased vaccines, healthcare professionals could charge for the cost of administering the vaccine.

“We appreciate the confidence of the U.S. government in our mRNA vaccine platform and the continued support,” said Stéphane Bancel, Moderna’s Chief Executive Officer. “We are advancing the clinical development of mRNA-1273 with the ongoing Phase 3 study being conducted in collaboration with NIAID and BARDA. In parallel, we are scaling up our manufacturing capability with our strategic partners, Lonza, Catalent and Rovi, to address this global health emergency with a safe and effective vaccine.”

Moderna is currentyly working closely with BARDA and the NIH, including NIAID’s COVID-19 Prevention Network (CoVPN), to conduct the Phase 3 COVE study under the auspices of Operation Warp Speed. The vaccine efficacy trial is the first to be implemented under Operation Warp Speed, a multi-agency collaboration led by HHS that aims to accelerate the development, manufacturing and distribution of medical countermeasures for COVID-19.

“For Operation Warp Speed, we are assembling a broad portfolio of vaccines to increase the odds that we will have at least one safe, effective vaccine as soon as the end of this year,” said HHS Secretary Alex Azar. “With this latest investment, we will have supported the vaccine candidate developed by Moderna in partnership with the NIH all the way from early development through clinical trials and now manufacturing, with the potential to bring millions of safe and effective doses to the American people.”

So far,  Modernaa remains on track to be able to deliver approximately 500 million doses per year, and possibly up to 1 billion doses per year, beginning in 2021 because of the Company’s internal U.S. manufacturing capabilities and strategic collaboration with Lonza, Ltd.


Source: https://techstartups.com/2020/08/11/us-government-reached-1-5-billion-deal-moderna-100-million-doses-coronavirus-vaccine/

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Dr. Scott Atlas, the anti-Fauci Stanford doctor, joins the White House Coronavirus Task Force team

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Back in June, we wrote about Dr. Scott Atlas when the former chief of neuroradiology at Stanford University Medical Center and a senior fellow at Stanford’s Hoover Institution, said that the rise in coronavirus hospitalizations among young people is a good thing because it leads to herd immunity over the long term.

Dr. Atlas, along with the handful of other European doctors, is one of the medical experts telling who thinks herd immunity is one of the best ways to overcome the deadly coronavirus. Unlike Dr, Anthony Fauci, Dr. Atlas told Americans back in June not to panic about the rise in coronavirus cases. Dr. Atlas later got the attention of US President Trump.

Yesterday, President Trump announced that Dr. Scott Atlas is now joining the Coronavirus Task Force team. President Trump said:

“…This is Scott Atlas. Do you know that? Right? …Scott is a very famous man who’s also very highly respected — Stanford. And he’s working with us and will be working with us on the coronavirus. And he has many great ideas. And he thinks what we’ve done is really good, and now we’ll take it to a new level. And so it’s great to have Scott working along with us. And we appreciate it very much, Scott. Thank you very much, Scott. Thank you very much.”

Back in June, Dr Atlas appeared with the host of “The Story with Martha MacCallum.” During the the show, Dr. Atlas said that since everyone who gets hospitalized for any reason is getting tested for COVID-19, the people making up the inflated statistics could actually be “hospitalized for something else” but “classified as COVID-19 hospitalizations.” Dr. Atlas also used the interview to lash out at medical journals. “Medical journals like Lancet are publishing garbage studies on coronavirus,” Dr. Atlas says.

Also in an op-ed piece in The Hill titled, “The data is in — stop the panic and end the total isolation,” Dr. Atlas provided five facts key facts that are being ignored by those calling for continuing the near-total lockdown:

  • Fact 1: The overwhelming majority of people do not have any significant risk of dying from COVID-19.
  • Fact 2: Protecting older, at-risk people eliminates hospital overcrowding.
  • Fact 3: Vital herd immunity is actually PREVENTED by total isolation policies, prolonging the problem.
  • Fact 4: People are dying from being denied other medical care due to hypothetical COVID-19 fatality projections that turned out to be garbage.
  • Fact 5: We have a clearly defined population at risk who can be protected with targeted measures.

Below is a Twitter video of President Trump’s announcement.


Source: https://techstartups.com/2020/08/11/dr-scott-atlas-anti-fauci-stanford-doctor-joins-white-house-coronavirus-task-force-team/

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