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Eli Lilly’s Antibody Trial Is Paused Over Potential Safety Concern

A government-sponsored clinical trial that is testing an antibody treatment for Covid-19 developed by the drugmaker Eli Lilly has been paused because of a “potential safety concern,” according to emails that government officials sent on Tuesday to researchers at testing sites. The company confirmed the pause.

The news comes just a day after Johnson & Johnson announced the pause of its coronavirus vaccine trial because of a sick volunteer, and a month after AstraZeneca’s vaccine trial was halted over concerns about two participants who had fallen ill after getting the company’s vaccine.

The Eli Lilly trial was designed to test the benefits of the antibody therapy on hundreds of people hospitalized with Covid-19, compared with a placebo. All of the study participants also received another experimental drug, remdesivir, which has become commonly used to treat coronavirus patients. It is unclear exactly what safety issues prompted the pause.

In large clinical trials, pauses are not unusual, and declines in health in volunteers are not necessarily the result of the experimental drug or vaccine. Such halts are meant to allow an independent board of scientific experts to review the data and determine whether the event may have been related to the treatment or occurred by chance.

“This is why clinical trials are essential,” said Marion Pepper, an immunologist at the University of Washington. “The safety of the product has to be empirically proven.”

Enrollment for the Eli Lilly trial, which was sponsored by several branches of the National Institutes of Health and the Department of Veterans Affairs, among other organizations, had been continuing. But on Tuesday, multiple officials sent emails to researchers telling them to stop adding volunteers to the study out of an “abundance of caution.”

In a statement, an N.I.H. spokeswoman said the trial, which had enrolled 326 Covid-19 patients, was paused when the independent safety board found that after five days of treatment, the group of patients who had received the antibodies showed a different “clinical status” than the group who had received a saline placebo — a difference that crossed a predetermined threshold for safety.

The N.I.H. statement did not specify the nature of the participants’ conditions. But the so-called stopping rules for the trial lay out the conditions for “futility” — the idea that a treatment has a very low chance of working, based on the data so far. A trial could also be halted if there is evidence that patients in one group are faring much worse than those in the other.

Given the ambiguity in the statements released on Tuesday, all scenarios remain possible, said Dr. Eric Topol, a clinical trials expert at the Scripps Research Institute. “It’s so amorphous,” Dr. Topol said.

The safety board will review the data again on Oct. 26, and advise the N.I.H. on whether to resume the trial, the statement said. In the meantime, researchers will continue to collect data from people already enrolled in the study.

Several experts praised the trial’s sponsors for halting the trial to address

Ionis’ inhaled antisense medicine demonstrates potential as a novel treatment for cystic fibrosis | News

CARLSBAD, Calif., Oct. 13, 2020 /PRNewswire/ — Ionis Pharmaceuticals, Inc. (NASDAQ: IONS), the leader in antisense therapeutics, announced today that data from a clinical trial of IONIS-ENAC-2.5Rx demonstrated a significant decrease in the expression of epithelial sodium channel (ENaC) in subjects with cystic fibrosis (CF). The study showed a mean 55.6 percent decrease (p<0.05) in ENaC mRNA expression at the 75 mg dose in the multidose segment of the trial. The study represents the first time an antisense medicine delivered directly to the lung via a nebulizer has shown a significant reduction in ENaC messenger RNA levels. In preclinical studies, ENaC mRNA reductions of 40 percent or more resulted in significant improvement in mouse models of CF lung disease.

IONIS-ENAC-2.5Rx is an investigational antisense medicine designed to reduce the expression of ENaC in the lung. ENaC is believed to be hyperactive in cystic fibrosis, which is caused by mutations in the cystic fibrosis transmembrane regulator gene. Data from the Phase 1 study will be presented via e-poster at the 2020 North American Cystic Fibrosis Conference, which will hold virtual sessions and discussions Oct. 21-23.

Cystic fibrosis is a life-threatening disease affecting approximately 30,000 people in the U.S. and about 70,000 worldwide. Although CF is a multisystem disease, the main cause of morbidity and mortality is lung disease, characterized by small airway obstruction due to mucus accumulation, decreased mucus clearing and subsequent inflammation, infections and lung function decline.

“We are very encouraged by these data, which demonstrate attractive tolerability and safety for IONIS-ENAC-2.5Rx with substantial target reduction and the convenience of once weekly administration. The data also confirm our expectations for aerosol delivery of antisense medicines for lung diseases based on a wealth of preclinical data,” said Brett P. Monia, Ph.D., Ionis’ chief executive officer. “These results point to the exciting potential for aerosol delivery of other Ionis medicines that we plan to advance to the clinic, including treatments for chronic obstructive pulmonary disease, or COPD, and severe asthma.”

The company also plans to initiate a clinical study to evaluate IONIS-ENAC-2.5Rx in patients with COPD associated with chronic bronchitis starting later this year. IONIS-ENAC-2.5Rx is one of more than 20 potentially transformative antisense medicines in the growing Ionis-owned pipeline that the company is prioritizing and preparing for commercialization.

The primary endpoint of the study was evaluation of safety and pharmacokinetics of IONIS-ENAC-2.5Rx delivered via a Pari eFlow mesh nebulizer. In the single escalating dose study, 32 subjects in four cohorts received a single dose of 3, 10, 37.5, or 100 mg and were followed for 30 days. In the multiple ascending dose study, 24 subjects in three cohorts received four doses of 10, 37.5, or 75 mg once weekly, with an additional dose administered during the first week. An additional cohort of eight subjects received a 37.5 mg dose given thrice weekly for 10 doses. Subjects were followed for 13 weeks after dosing. Fiberoptic bronchoscopy including bronchial brushings and bronchoalveolar lavage was

Ionis’ inhaled antisense medicine demonstrates potential as a novel treatment for cystic fibrosis

CARLSBAD, Calif., Oct. 13, 2020 /PRNewswire/ — Ionis Pharmaceuticals, Inc. (NASDAQ: IONS), the leader in antisense therapeutics, announced today that data from a clinical trial of IONIS-ENAC-2.5Rx demonstrated a significant decrease in the expression of epithelial sodium channel (ENaC) in subjects with cystic fibrosis (CF). The study showed a mean 55.6 percent decrease (p

(PRNewsfoto/Ionis Pharmaceuticals, Inc.)

IONIS-ENAC-2.5Rx is an investigational antisense medicine designed to reduce the expression of ENaC in the lung. ENaC is believed to be hyperactive in cystic fibrosis, which is caused by mutations in the cystic fibrosis transmembrane regulator gene. Data from the Phase 1 study will be presented via e-poster at the 2020 North American Cystic Fibrosis Conference, which will hold virtual sessions and discussions Oct. 21-23.

Cystic fibrosis is a life-threatening disease affecting approximately 30,000 people in the U.S. and about 70,000 worldwide. Although CF is a multisystem disease, the main cause of morbidity and mortality is lung disease, characterized by small airway obstruction due to mucus accumulation, decreased mucus clearing and subsequent inflammation, infections and lung function decline.

“We are very encouraged by these data, which demonstrate attractive tolerability and safety for IONIS-ENAC-2.5Rx with substantial target reduction and the convenience of once weekly administration. The data also confirm our expectations for aerosol delivery of antisense medicines for lung diseases based on a wealth of preclinical data,” said Brett P. Monia, Ph.D., Ionis’ chief executive officer. “These results point to the exciting potential for aerosol delivery of other Ionis medicines that we plan to advance to the clinic, including treatments for chronic obstructive pulmonary disease, or COPD, and severe asthma.”

The company also plans to initiate a clinical study to evaluate IONIS-ENAC-2.5Rx in patients with COPD associated with chronic bronchitis starting later this year. IONIS-ENAC-2.5Rx is one of more than 20 potentially transformative antisense medicines in the growing Ionis-owned pipeline that the company is prioritizing and preparing for commercialization.

The primary endpoint of the study was evaluation of safety and pharmacokinetics of IONIS-ENAC-2.5Rx delivered via a Pari eFlow mesh nebulizer. In the single escalating dose study, 32 subjects in four cohorts received a single dose of 3, 10, 37.5, or 100 mg and were followed for 30 days. In the multiple ascending dose study, 24 subjects in three cohorts received four doses of 10, 37.5, or 75 mg once weekly, with an additional dose administered during the first week. An additional cohort of eight subjects received a 37.5 mg dose given thrice weekly for 10 doses. Subjects were followed for 13 weeks after dosing. Fiberoptic bronchoscopy including bronchial brushings and bronchoalveolar lavage was performed during screening and after completion of dosing in the MAD cohorts. Quantitative RT-PCR was performed from the bronchial cell brushings to evaluate ENaC mRNA levels.

About Ionis Pharmaceuticals

As the leader in RNA-targeted drug discovery and development, Ionis has created an efficient, broadly applicable, drug discovery platform called antisense technology that can treat diseases where no other therapeutic approaches have proven effective. Our

Being overweight now potential coronavirus risk factor, CDC says

The Centers for Disease Control and Prevention (CDC) has expanded its coronavirus risk warning to include people who are considered overweight, meaning over 70% of U.S. adults may be at an increased risk for severe illness related to COVID-19.

According to CDC statistics, over 71% of Americans aged 20 and older are considered overweight or obese. Obesity is defined as having a body mass index of between 30 and 40, with severe obesity being diagnosed when BMI is 40 or above. Being overweight, however, is classified as having a BMI greater than 25 but less than 30. The health agency now says that if you fall into that category, it “might increase your risk of severe illness from COVID-19.”

OBESITY CAN INCREASE CORONAVIRUS-RELATED DEATH RISK BY ALMOST 50%, STUDY FINDS

Other risk factors that might increase the risk of severe illness include asthma, cerebrovascular disease, cystic fibrosis, hypertension, immunocompromised state, neurologic conditions, liver disease, pregnancy, pulmonary fibrosis, thalassemia and Type 1 diabetes. 

The CDC’s update follows numerous studies that have found that obesity may increase the risk of COVID-19-related death, including one that found the increase to be as much as 50%. The same University of North Carolina, Chapel Hill study found that those with a BMI of over 30 are more likely to be hospitalized or admitted to the ICU due to the virus. According to the research, obesity is over tied to other underlying risk factors for novel coronavirus identified by the CDC such as heart disease, Type 2 diabetes, chronic kidney, liver disease and hypertension.

HOME IS WHERE AMERICANS FEEL SAFEST DURING PANDEMIC, STUDY FINDS

Further, individuals who have obesity can have metabolic changes that result in inflammation, issues with insulin, and the immune system which can hamper the body’s ability to fight off COVID-19. The researchers suggested preventative action among the obese population that was not unlike the steps listed by the CDC.

“Given the significant threat COVID-19 represents to individuals with obesity, healthy food policies can play a supportive – and especially important role in the mitigation of COVID-19 mortality and morbidity,” Barry Popkin, Ph.D., professor of nutrition at the UNC Gillings School of Global Public Health, said in a news release at the time.

CLICK HERE FOR COMPLETE CORONAVIRUS COVERAGE 

Additionally, the CDC advises taking prescription medicines for overweight, obesity or severe obesity exactly as prescribed, following a health care providers recommendations for nutrition and physical activity while maintaining social distancing, calling health care provider of you have concerns or feel sick, and in the event that you don’t have a health care provider, contacting the nearest community health center or health department.

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First Patient Enrolled in NIH Phase 3 Trial to Evaluate Potential COVID-19 Hyperimmune Medicine

The Alliance’s anti-COVID-19 Hyperimmune Globulin (CoVIg-19) medicine is under evaluation as part of the trial and may become one of the earliest treatments for hospitalized individuals at risk for serious complications of COVID-19

The CoVIg-19 Plasma Alliance urges anyone who has recovered from COVID-19 to consider donating plasma. To learn more, please visit TheFightIsInUs.org. 

OSAKA, Japan and KING OF PRUSSIA, Pa., Oct. 8, 2020 /PRNewswire/ — The CoVIg-19 Plasma Alliance, an unprecedented collaboration of leading plasma companies supported by global organizations outside the plasma industry, today confirmed that patients are now being enrolled in the Inpatient Treatment with Anti-Coronavirus Immunoglobulin (ITAC) Phase 3 clinical trial sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The trial will evaluate the safety, tolerability and efficacy of an investigational anti-coronavirus hyperimmune intravenous immunoglobulin (H-Ig) medicine for treating hospitalized adults at risk for serious complications of COVID-19 disease. If successful, the Alliance’s H-Ig may become one of the earliest treatment options for hospitalized COVID-19 patients.

The first patient has been enrolled in NIH Phase 3 trial to evaluate CovIg-19 Plasma Alliance’s potential COVID-19 hyperimmune medicine.
The first patient has been enrolled in NIH Phase 3 trial to evaluate CovIg-19 Plasma Alliance’s potential COVID-19 hyperimmune medicine.

This global multi-center, double-blind, placebo-controlled, randomized trial will enroll 500 adult patients at up to 58 sites in the United States, Mexico and 16 other countries on five continents  (utilizing the NIH’s global INSIGHT Network), who have been hospitalized for COVID-19 and have had symptoms for 12 days or fewer without life-threatening organ dysfunction or end-organ failure. Patients will receive remdesivir as standard of care, allowing the safety and efficacy of H-Ig to be evaluated when given along with remdesivir treatment. The investigational H-Ig materials for the trial will be provided by CSL Behring and Takeda on behalf of the CoVIg-19 Plasma Alliance, as well as by two other companies. 

“The rapid progress we’ve made since we initiated this program just a few months ago to reach this key milestone of enrolling patients in the trial is a powerful testament to the collaboration, determination and innovation taking place across the biomedical community as we work to fight the COVID-19 pandemic,” said Julie Kim, President of Plasma-Derived Therapies Business Unit, Takeda and co-leader of the CoVIg-19 Alliance. “This study will help us understand how CoVIg-19 could potentially become an important therapeutic option. To support our efforts, we encourage all those people who have recovered from COVID-19 to donate their plasma, which contains vital antibodies that have fought off the disease and could help others do the same.”

“When we created the CoVIg-19 Plasma Alliance in April, the goal was to partner to accelerate our timelines so that we could develop and deliver a reliable and sustainable treatment option for people suffering the impact of COVID-19 and to support countries around the world in their efforts to fight the current pandemic,” said Bill Mezzanotte, MD, MPH, Executive Vice President, Head of Research and Development and Chief Medical Officer, CSL Behring and co-leader of

Chile scientists study potential coronavirus mutation in remote Patagonia

SANTIAGO (Reuters) – Scientists in Chile are investigating a possible mutation of the novel coronavirus in southern Patagonia, a far-flung region near the tip of the South American continent that has seen an unusually contagious second wave of infections in recent weeks.

Dr. Marcelo Navarrete of the University of Magallanes told Reuters in an interview that researchers had detected “structural changes” in the spikes on the distinctive, crown-shaped virus. He said research is underway to better understand the potential mutation and its effects on humans.

“The only thing we know to date is that this coincides in time and space with a second wave that is quite intense in the region,” Navarrete said.

The Magallanes region of Chile is largely a remote, glacier-strewn wilderness dotted with small towns and the regional hub Punta Arenas, which has seen cases of COVID-19 spike in September and October following a first wave earlier this year.

Hospitals are nearing full occupancy in the hard-hit region. Chilean health ministry officials said they have begun evacuating sick residents from the region to the capital, Santiago.

Other studies outside Chile have also indicated that the coronavirus can evolve as it adapts to its human hosts.

A preliminary study that analyzed the virus’ structure following two waves of infection in the U.S. city of Houston found that a more contagious strain dominated recent samples.

Navarrete acknowledged similar mutations had been observed elsewhere, but he said the relative isolation and harsh climate of the famously cold and windy Magallanes region may have exaggerated its impacts.

“Some of these variables such as cold, wind, are associated with a higher rate of spread in the world,” Navarrete said.

Scientists say the mutations may make the virus more contagious but do not necessarily make it more deadly, nor do they necessarily inhibit the effectiveness of a potential vaccine.

(Reporting by Reuters TV, writing by Dave Sherwood; Editing by Hugh Lawson)

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Pence, Harris spar over potential coronavirus vaccine

Vice President Mike Pence and Sen. Kamala Harris (D-Calif.), the Democratic vice presidential nominee, sparred over a potential coronavirus vaccine during Wednesday night’s vice presidential debate.

Harris, who in the past has wavered about whether she would take a vaccine approved under the Trump administration’s watch, said if medical experts, like Dr. Anthony Fauci, sign off on a candidate, “I’ll be the first in line to take it.” But she clarified if President Trump “tells us to take it, them I’m not taking it.”

Pence chose to respond to Harris’ remarks when asked a separate question, accusing her of continuing to “undermine public confidence in a vaccine,” which he said was “unconscionable.” He then asked the senator to “stop playing politics with people’s lives” before reiterating the White House’s belief that a vaccine will be approved by the Food and Drug Administration by the end of the year.

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Potential Coronavirus Outbreak Reported At Nashua Church

NASHUA, NH — State health officials are investigating a potential COVID-19 outbreak at a Nashua church.

Seven people who attend services at the Gate City Church on Main Street in Nashua in September have contracted the virus, according to officials. Those people who became infected attended multi-day prayer sessions held between Sept. 19 and Sept. 28.

“DHHS and the Nashua Division of Public Health and Community Services are investigating these illnesses further and the church has moved to hosting virtual services only,” the State Joint Information Center said. “Any individuals who attended events associated with Gate City Church since Sept. 19 may have been exposed to COVID-19 and should observe for illness and seek testing.”

Testing is available for anyone without health insurance or a primary care provider. Tests can be scheduled by calling 603-271-5980 or through completing the online form at the state’s testing website.

Potential symptoms parishioners should be looking for include fever, chills, cough, shortness of breath, runny nose, nasal congestion, sore throat, fatigue, headache, muscle aches, nausea, vomiting, diarrhea, or loss of taste or smell.

Any person who develops new symptoms should stay home, limit their contact with others, immediately contact their healthcare provider, and get tested for COVID-19.

Guidance for self-observation is available here.

COVID-19 continues to circulate in New Hampshire communities, according to health officials, but Granite Staters can protect themselves and help prevent further infections in our communities by:

  • Washing your hands often with soap and water for at least 20 seconds or use an alcohol-based hand sanitizer that contains at least 60 percent alcohol if soap and water are not available.

  • Avoiding close contact with others. When outside your home, keep a distance of at least 6 feet between yourself and others. This is known as social distancing.

  • Wearing a cloth face covering that covers your mouth and nose to protect others when in public areas.

  • Covering your mouth and nose with a tissue when you cough or sneeze, then throw the tissue in the trash and wash your hands.

  • Avoiding touching your eyes, nose, or mouth with unwashed hands.

  • Staying home if you have a fever or are not feeling well.

  • Cleaning and disinfecting frequently touched objects and surfaces.

For more information on COVID-19 in NH, visit https://www.nh.gov/covid19/.

Got a news tip? Send it to [email protected] View videos on Tony Schinella’s YouTube channel.

This article originally appeared on the Nashua Patch

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ARCA biopharma Announces FDA Approval of IND Application for AB201 as a Potential Treatment for COVID-19

Dr. Bristow

Dr. Michael Bristow, President and CEO, ARCA biopharma, Inc.
Dr. Michael Bristow, President and CEO, ARCA biopharma, Inc.
Dr. Michael Bristow, President and CEO, ARCA biopharma, Inc.
  • Initiation of Phase 2b clinical trial anticipated in Q4 2020

  • Trial to enroll approximately 100 patients hospitalized with COVID-19

  • Topline data anticipated Q2 2021

WESTMINSTER, Colo., Oct. 07, 2020 (GLOBE NEWSWIRE) — ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically targeted therapies for cardiovascular diseases, today announced the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for AB201 (rNAPc2) as a potential treatment for patients hospitalized with COVID-19. ARCA anticipates initiating a Phase 2b/3 sequential clinical trial, ASPEN-COVID-19, of AB201 in approximately 100 patients hospitalized with COVID-19 in the fourth quarter of this year, with Phase 2b followed by a contiguous Phase 3 study that is dependent on Phase 2 results. The Company anticipates topline data from the trial in the second quarter of 2021.

The planned Phase 2b trial is anticipated to be a randomized comparison of two dose regimens of AB201 versus heparin prescribed per local standard of care. The clinical course of some patients with COVID-19 is complicated by a virus-triggered coagulopathy that includes thrombotic events and inflammatory processes, thought to be mediated in part by tissue factor production. AB201 is a potent tissue factor inhibitor anticoagulant with anti-inflammatory and antiviral properties. The primary endpoint of the trial will be change in D-dimer level from baseline to Day 8. D-dimer is a biomarker commonly used for assessing coagulation activation, which is elevated in approximately 50% of hospitalized COVID-19 patients and is directly associated with adverse clinical outcomes.   If Phase 2b indicates a favorable effect on D-dimer levels, following FDA review of the data and identification of the proposed Phase 3 AB201 dose, the Company anticipates that clinical investigative sites will begin enrolling in the planned Phase 3 clinical trial. The primary endpoint of Phase 3 will be clinical recovery as measured by the Adaptive COVID-19 Treatment Trial (ACTT-1) ordinal scale, with secondary endpoints that include D-dimer levels and the number of thrombotic events. Phase 3 will be event driven, with an estimated requirement of 450 patients. The Phase 2b and Phase 3 trials are described in a common protocol and use identical entry criteria and the same heparin regimen control.

Dr. Michael Bristow, ARCA’s President and Chief Executive Officer, who is also an American Heart Association (AHA) funded COVID-19 investigator, commented, “The ASPEN-COVID-19 trial will use the coagulopathy biomarker D-dimer to identify an optimal dose from AB201 regimens that are both within the therapeutic range as determined from Phase 2 trials investigating cardiovascular thrombosis prophylaxis. If successful, we anticipate using this dose in a planned Phase 3 trial to evaluate potential improvement in clinical outcomes. We believe that the combination of anticoagulant, anti-inflammatory and antiviral effects of AB201 may favorably impact clinical recovery of patients hospitalized with COVID-19.”

The trial is being managed in collaboration with the Colorado Prevention Center (CPC),

Apples, Grapes, Mango At Walmart Recalled For Potential Listeria

Walmart shoppers should check the dates on their fruit. Country Fresh has expanded their voluntary recall on cut fruit sold at Walmart for possible listeria contamination.

As IBT reported last week, a recall was issued for watermelon sold in Arkansas, Missouri, Illinois, Oklahoma, and Texas at Walmart and RaceTrac. Country Fresh has now extended their voluntary recall to include more fruits in nine states.

In addition to watermelon, the recall now includes clamshell containers of “Freshness Guaranteed” cut and/or sliced apples, grapes, mangos, pineapples and cantaloupe distributed by Walmart. Arkansas, Illinois, Indiana, Kansas, Kentucky, Louisiana, Missouri, Oklahoma and Texas are affected by the fruit recall.

“The recall is a precautionary measure due to a possible health risk from Listeria monocytogenes detected on equipment used in an area near where these products are packed. FDA discovered these findings during a recent inspection,” a press release reads.

The cut fruit being recalled has expiration dates between Oct. 3 and Oct. 11. To see the full list of products and UPC codes to look out for, check out the FDA website. Also, look at Walmart’s list of stores affected by the recall.

Walmart is removing any recalled products from shelves, and customers who already purchased them are advised to discard the possibly contaminated fruit.

Consumers with questions can contact Country Fresh customer service at 1-877-251-8300.

Walmart fruit The produce section at Walmart is pictured. Photo: Courtesy of Walmart

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