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Wednesday, July 22, 2020

Arcturus Therapeutics on go with Phase 1/2 study on COVID-19 vaccine

Singapore’s Health Sciences Authority has signed off on Phase 1/2 clinical trial evaluating Arcturus Therapeutics Holdings (NASDAQ:ARCT) and Duke-NUs Medical School’s mRNA-based COVID-19 vaccine candidate LUNAR-COV19 in up to 108 healthy adult volunteers.
The company says its STARR technology platform used in the vaccine combines self-replicating mRNA and a proprietary nanoparticle delivery system optimized for mRNA molecules called LUNAR. The approach enables very low doses and potential single-shot administration.
Preclinical data showed levels of neutralizing antibodies that continued to increase over 50 days.

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Mylan gets Indian regulatory approval for tuberculosis drug

July 22, 2020

Drugmaker Mylan NV said on Wednesday it has received Indian regulatory approval to make tuberculosis treatment pretomanid available in a country that accounts for a quarter of the world’s cases.
Mylan will initially make a donation of 400 treatment courses of pretomanid under the Indian government’s National Tuberculosis Elimination Program (NTEP) and will provide commercial access at $364 for a six-month treatment course.
“The Drug Controller General of India has approved the anti-tuberculosis drug pretomanid for conditional access under the NTEP,” Mylan said in an emailed statement.
New treatments against tuberculosis have been sparse, with pretomanid being only the third new drug developed for drug-resistant forms of the disease to be approved in more than 40 years, after Johnson & Johnson’s bedaquiline and Otsuka Pharmaceutical Co Ltd’s delamanid.
The approval comes amid fears the coronavirus outbreak has derailed global efforts to curtail the spread of tuberculosis, a bacterial infection that mainly affects a patient’s lungs.
Between 2020 and 2025, an additional 1.4 million tuberculosis deaths could be registered as a direct consequence of the COVID-19 pandemic, the World Health Organization said bit.ly/2WGC48T in May.
Tuberculosis is one of the leading causes of mortality in India, killing more than 300,000 people in the country every year, according https://tbcindia.gov.in to the Central Tuberculosis Division set up by the nation’s health ministry.
Pretomanid has been approved as part of a three-drug, six-month all-oral regimen for the treatment of highly drug-resistant forms of tuberculosis. The three-drug combination also consists of linezolid and J&J’s bedaquiline.
Not-for-profit TB Alliance granted a non-exclusive license to Mylan to manufacture and sell pretomanid in April last year. Pretomanid as part of the three-drug combination was approved by the U.S. Food and Drug Administration in August last year.

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Aurinia Pharma voclosporin accelerated review for kidney inflammation

July 22, 2020

The FDA has accepted Aurinia Pharmaceuticals’ (NASDAQ:AUPH) New Drug Application (NDA) for voclosporin, as a potential treatment for lupus nephritis, an inflammation of the kidneys caused by the autoimmune disease systemic lupus erythematosus.
The Agency has granted Priority Review for the NDA and has assigned a PDUFA target action date of January 22, 2021.
The FDA currently do not plan to hold an advisory committee meeting to discuss the application.

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Thermo Fisher Scientific EPS beats by $1.00, beats on revenue

Thermo Fisher Scientific (NYSE:TMO): Q2 Non-GAAP EPS of $3.89 beats by $1.00; GAAP EPS of $2.90 beats by $0.83.
Revenue of $6.92B (+9.5% Y/Y) beats by $10M.
Adjusted operating margin of 27.0% vs. consensus of 22.0%.
Press Release

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Tuesday, July 21, 2020

Yale Epidemiologist: Hydroxychloroquine Could Save 100,000 Lives If Widely Used

Yale epidemiology professor Dr. Harvey Risch told Fox News‘s “Ingraham Angle” that he thinks hydroxychloroquine could save 75,000 to 100,000 lives if widely used to treat COVID-19, and that it’s unfortunate that a “propaganda war” has been waged on the commonly
Researchers at the Henry Ford Health System in Southeast Michigan have found that early administration of hydroxychloroquine makes hospitalized patients substantially less likely to die.
The study, published in the International Journal of Infectious Diseases, determined that hydroxychloroquine provided a “66 percent hazard ratio reduction,” and hydroxychloroquine and azithromycin a 71 percent reduction, compared with neither treatment.
In-hospital mortality was 18.1 percent overall; 13.5 percent with just hydroxychloroquine, 22.4 percent with azithromycin alone, and 26.4 percent with neither drug. “Prospective trials are needed” for further review, the researchers note, even as they concluded: “In this multi-hospital assessment, when controlling for COVID-19 risk factors, treatment with hydroxychloroquine alone and in combination with azithromycin was associated with reduction in COVID-19 associated mortality.” –Fox News
“All the evidence is actually good for it when it is used in outpatient uses. Nevertheless, the only people who actually say that are a whole pile of doctors who are on the front lines treating those patients across the country and they are the ones who are at risk being forced not to do it,” Risch added, arguing that the MSM refuses to cover the benefits of the drug, and is actively silencing those trying to address the efficacy of HCQ.
Imagine how many people have died thanks to the media’s ‘propaganda war.’
“Our results do differ from some other studies,” said Dr. Marcus Zervos, head of the Henry Ford Health System’s infectious diseases unit. “What we think was important in ours … is that patients were treated early. For hydroxychloroquine to have a benefit, it needs to begin before the patients begin to suffer some of the severe immune reactions that patients can have with COVID.”

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Nitric oxide may slow progression of COVID-19

Nitric oxide treatment can be pivotal in the world’s fight against SARS-CoV-2, the coronavirus that causes COVID-19, according to a review from the George Washington University (GW). The article is published in the journal Nitric Oxide.
Nitric oxide is an antimicrobial and anti-inflammatory molecule with key roles in pulmonary vascular function in the context of viral infections and other pulmonary diseases. In SARS-CoV-1 infection, which led to the outbreak of SARS () in 2003, inhibited viral replication by cytotoxic reactions through intermediates such as peroxynitrite. It is one of several potential COVID-19 treatments included in the U.S. Food and Drug Administration’s emergency expanded access program.
“Nitric oxide plays key roles in maintaining normal vascular function and regulating inflammatory cascades that contribute to (ALI) and (ARDS),” said Adam Friedman, MD, interim chair and professor in the Department of Dermatology at the GW School of Medicine and Health Sciences and co-senior author of the review. “Interventions that are protective against ALI and ARDS can play a critical role for patients and during the pandemic.”
Coronaviruses are RNA viruses that primarily infect birds or livestock, but can mutate to be highly infectious and lethal in humans. There is currently no registered treatment or vaccine for COVID-19. The absence of a specific treatment and the high mortality rate of the virus dictate an urgent need for therapeutics that may control the replication and rapid spread of the virus.
The team, led by first author Nagasai Adusumilli, MBA, a fourth-year medical student at the GW School of Medicine and Health Sciences, reviewed data from between 1993 and 2020 on the pathogenesis of coronaviruses and the use of nitric oxide as a treatment for respiratory illness. The authors highlight the potential for inhaled nitric oxide contributing to better clinical outcomes and alleviating the rapidly rising strain on health care capacity due to COVID-19.
As groups continue to publish more results with their respective nitric oxide platforms, the team recommends that dosing and protocol variations should be examined in evaluating the studies.
“With the emergence of COVID-19 as a pandemic with the ability to overwhelm the body and our health care infrastructure, patients have a pressing need for effective agents that can slow the disease in their bodies and in their communities,” Friedman said.
The authors suggest that if nitric oxide’s efficacy is illustrated for COVID-19, its use as a treatment can be pivotal in the fight against the pandemic.
Friedman has been collaborating with co-senior author Joel Friedman, MD, Ph.D., professor of physiology and biophysics and of medicine at Albert Einstein College of Medicine, on research related to the use of nitric oxide in a broad range of medical indications for close to two decades, and together are developing oxide-based therapeutics for COVID-19.
Explore further
More information: Nagasai C. Adusumilli et al, Harnessing nitric oxide for preventing, limiting and treating the severe pulmonary consequences of COVID-19, Nitric Oxide (2020). DOI: 10.1016/j.niox.2020.07.003

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Findings from 1st statewide COVID-19 random sample study in US

The results of the first statewide random sample study in the United States to measure the spread of COVID-19 indicated a general population prevalence of about 2.8 percent in Indiana.
This closely monitored study was conducted by the Indiana University Richard M. Fairbanks School of Public Health at IUPUI in collaboration with the Indiana State Department of Health. The findings were published July 21 in Morbidity and Mortality Weekly Report, the U.S. Centers for Disease Control and Prevention’s scientific publication.
“Using data to guide decisions has been the foundation of how the State of Indiana responds to the pandemic,” Indiana Gov. Eric J. Holcomb said. “We are fortunate to have the Fairbanks School of Public Health conduct this first-of-its kind study for us and look forward to the information that will come with future waves of the random sample testing.”
Between April 25 and May 1, researchers tested more than 4,600 Hoosiers for and antibodies of SARS-CoV-2, the novel coronavirus that causes COVID-19. This number includes more than 3,600 people who were randomly selected from a master list of Indiana residents derived from tax returns, including filers and dependents; and an additional 900 volunteers recruited through nonrandom outreach to the African American and Hispanic communities to get a more in-depth view of the virus’s activity within hard-hit populations.
“Because we cannot test everyone, random sample testing allows us to confidently evaluate the spread of COVID-19 in Indiana,” said Nir Menachemi, lead scientist on the study and professor and Fairbanks Endowed Chair in the Fairbanks School of Public Health. “The results of this study have furthered our scientific knowledge of COVID-19 and contributed valuable information that influenced complex statewide decision-making.”
The researchers determined that 1.7 percent of participants tested positive for the novel coronavirus and an additional 1.1 percent tested positive for antibodies, resulting in an estimated overall population prevalence of SARS-CoV-2 of 2.8 percent. An estimated 187,802 Hoosiers were infected with COVID-19 at the time of the study, approximately 10 times higher than the confirmed cases in the state.
Participants who reported living with someone who tested positive for COVID-19 had a prevalence rate of 33.6 percent.
“The percentage of participants who had a positive test result was 15 times higher among participants who lived with someone who had received a diagnosis of COVID-19,” Menachemi said. “Coupled with the low statewide prevalence, we believe that social distancing efforts helped to minimize the spread of COVID-19 and is an important measure in preventing transmission.”

The research team also found that 44.2 percent of participants who tested positive reported no symptoms during the two weeks before testing. Of those who tested positive, 60.3 percent of males reported being asymptomatic, compared to 24.5 of females who were asymptomatic.
“The study’s findings among are crucial to our efforts to mitigate the spread of COVID-19 in Indiana,” said State Health Commissioner Kris Box, M.D., FACOG. “Hoosiers may not feel sick but can still infect someone else, so it’s vital that every Hoosier takes steps to reduce the spread of this virus.”
Rates of current or previous infection were significantly higher among Hispanic participants, at 8.32 percent, than among non-Hispanics, at 2.29 percent.
The nonrandom sample had higher infection rates, including 22.8 percent of participants who were currently infected; 20 percent of those infected reported being asymptomatic. These findings suggest that nonrandom samples are more suitable for determining the impact of the virus in vulnerable communities, but not for deriving state estimates of infections.
“Because most Hoosiers had not been infected at the time of the study, we need to continue social distancing, make sure we are washing our hands often and always wearing a mask when we are in public,” Menachemi said.
Explore further
More information: Nir Menachemi et al, Population Point Prevalence of SARS-CoV-2 Infection Based on a Statewide Random Sample—Indiana, April 25–29, 2020, MMWR. Morbidity and Mortality Weekly Report (2020). DOI: 10.15585/mmwr.mm6929e1

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