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Eli Lilly says other COVID-19 antibody drug trials ongoing after study halted for safety concern

By Carl O’Donnell and Michael Erman



a large building: FILE PHOTO: Eli Lilly logo is shown on one of their offices in San Diego


© Reuters/MIKE BLAKE
FILE PHOTO: Eli Lilly logo is shown on one of their offices in San Diego

(Reuters) – Eli Lilly & Co on Wednesday said other trials of its experimental coronavirus antibody therapy remain on track after a government-run study testing the treatment in hospitalized COVID-19 patients was paused due to safety concerns.

Lilly said on Tuesday that an independent safety monitoring board requested a pause in the trial, called ACTIV-3, due to a potential safety issue.

The National Institutes of Health (NIH), which is collaborating with Lilly on the trial, said the advisory board paused the trial after seeing a “difference in clinical status” between patients on Lilly’s drug on those who received a placebo, without providing further detail.

Lilly on Wednesday said the paused trial is distinct from others it is conducting because it focuses on hospitalized patients who are more severely ill and being treated with other drugs as well, including Gilead Sciences Inc’s antiviral remdesivir.

The company had already asked U.S. regulators for an emergency use authorization (EUA) for the antibody drug, called bamlanivimab or LY-CoV555, to treat mild to moderate COVID-19 patients, based on interim data from a different study in those less severe illness. It is also testing the drug in nursing homes to see if it can prevent staff and residents from getting infected.

The U.S. Food and Drug Administration did not immediately respond to a request for comment on the status of the EUA application.

LY-CoV555 is similar to the experimental dual-antibody therapy from Regeneron Pharmaceuticals Inc that was used to treat U.S. President Donald Trump. That treatment is also awaiting clearance by U.S. regulators.

Trump touted both drugs as being tantamount to cures in a video he posted last week after being released from the hospital.

Lilly said in a statement that these type of treatments may prove to be less beneficial for hospitalized patients than for those with more mild cases of the disease. A Lilly spokeswoman declined to comment further on why the trial was halted.

The paused trial is being conducted in partnership with the U.S. National Institute of Allergy and Infectious Diseases, a division of the NIH that is working with several drugmakers on COVID-19 treatments and vaccines.

It was halted at the request of an independent oversight panel, called a Data Safety and Monitoring Board (DSMB). It is not uncommon to pause drug trials to investigate safety concerns, and such actions do not necessarily indicate a serious problem.

“Lilly trusts the judgment of the independent DSMB and supports its decisions to exercise caution in ensuring the safety of the patients participating in this study,” the company said in a statement.

(Reporting by Carl O’Donnell; Editing by Chizu Nomiyama and Bill Berkrot)

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New lockdowns from China to Europe as virus trials stumble

As Europe imposed new restrictions to try to stall a surging second wave of the novel coronavirus, hopes for vaccines to rapidly provide relief suffered a blow Tuesday with the suspension of two clinical trials in the United States.

China meanwhile rushed to test an entire city of nine million within days after a minor coronavirus outbreak in the sprawling country, and Europe struggled to tackle a new surge of infections.

The virus is still spreading rapidly worldwide, with over one million deaths and 37 million infections. Many nations that suppressed their first outbreaks now face a second wave.

Hopes for a rapid vaccine rollout suffered a setback as US pharmaceutical firm Eli Lilly said it had suspended the Phase 3 trial of its antibody treatment over an unspecified incident, the second in less than 24 hours after Johnson & Johnson ran into a similar problem.

In Europe, the Netherlands imposed a “partial lockdown” to curb one of the region’s worst coronavirus surges, with all bars, cafes and restaurants to close, and non-medical face coverings mandatory in all indoor spaces for people aged over 13.

In Britain, Labour opposition leader Keir Starmer called for a 2-3 week “circuit break” lockdown to slow the rates, saying the government had “lost control” of the outbreak having ignored stringent measures suggested by scientific experts on September 21.

French President Emmanuel Macron is expected to announce tighter restrictions and faster testing in a prime-time TV interview late Wednesday, with some media speculating Paris and other cities could face evening curfews.

Meanwhile China — where Covid-19 first emerged late last year — launched a drive to test all residents of Qingdao after a handful of cases were detected on Sunday.

More than four million samples had been collected and 1.9 million results returned as of Tuesday afternoon, Qingdao authorities said, adding that no new cases had been found beyond already confirmed infections.

Chinese officials intend to test the entire city — around 9.4 million people — by Thursday.

In scenes contrasting with the fumbled testing efforts elsewhere, health workers in protective clothing swiftly set up tents and residents queued up to provide samples.

As the rest of Europe struggled to contain the disease, Russia also reported its highest-ever number of daily virus deaths, at 244, and a record number of new cases at almost 14,000.

Italy imposed new, tougher rules to control a resurgence, including an end to parties, amateur football matches and snacking at bars at night.

Polish Prime Minister Mateusz Morawiecki became the latest high-profile figure to go into quarantine after coming into contact with an infected person.

And Portugal’s football federation said star striker Cristiano Ronaldo had tested positive for the virus.

– ‘Ethically problematic’ –

In opposition to lockdowns and social distancing, some politicians have proposed letting the coronavirus circulate in the population to build up “herd immunity” — where so much of the population has been infected there are insufficient new victims for the virus to jump to.

Johnson & Johnson Paused Trials on Its COVID-19 Vaccine Due to Subject’s “Unexplained Illness”

Update, Oct. 13: Johnson & Johnson announced that it has paused all of its COVID-19 vaccine candidate clinical trials, including a large-scale Phase 3 human trial called “Ensemble” that began in September and aimed to enroll up to 60,000 people across three continents. One of the participants in that trial had an “unexplained illness,” the company said.

The Phase 3 clinical trial was in the process of comparing the efficacy of a single-dose vaccine versus a placebo. A company statement explained that the participant’s illness is currently being reviewed, and no other information has been released about the participant’s condition out of privacy. “Adverse events – illnesses, accidents, etc. – even those that are serious, are an expected part of any clinical study, especially large studies,” the company wrote. “We’re also learning more about this participant’s illness, and it’s important to have all the facts before we share additional information.”

This pause, Johnson & Johnson explained, is different than a regulatory hold put in place by a health authority such as the FDA. “As noted in the ENSEMBLE study protocol, Johnson & Johnson has robust mechanisms in place to protect the safety of participants in its clinical trials. While the Company informs all study investigators, we typically do not communicate study pauses publicly,” the company’s statement reads (it does, however, normally disclose information about regulatory holds). Stat News was the first outlet to report on this trial pause on Oct. 12.

Original post: Pharmaceutical brand Johnson & Johnson has been working on a coronavirus vaccine since January 2020, as soon as the virus’s genetic sequence became available. On March 30, the company announced plans to begin human testing of the vaccine in September, working towards an anticipated emergency use date in early 2021.

It’s a “substantially accelerated timeline,” the company noted in a press release; typical vaccine development can take five to seven years before a viable candidate is considered for approval, it said. The company’s manufacturing sector is ramping up production as well, with the goal of eventually providing over one billion doses of the vaccine globally.

“The world is facing an urgent public health crisis,” said Alex Gorsky, the chairman and CEO of Johnson & Johnson, in the press release. “We are committed to doing our part to make a COVID-19 vaccine available and affordable globally as quickly as possible.” He noted that the company’s research, operational, and financial capabilities put it in a favorable position to quickly develop and distribute a vaccine.

Related: If You Have COVID-19 Symptoms, This Is How You Can Take Care of Yourself at Home

Johnson & Johnson has also partnered with the Biomedical Advanced Research and Development Authority (BARDA), part of the US Department of Health and Human Services, to commit $1 billion in funding towards vaccine research, development, and testing, the company said.

It’s hopeful news, especially considering that Johnson & Johnson is just one of multiple pharmaceutical companies rapidly working towards a COVID-19 vaccine; Moderna’s vaccine began its

Pauses of coronavirus antibody and vaccine trials are routine, doctor says

Two setbacks have been reported in 24 hours in the fight against the coronavirus. On Tuesday, drugmaker Eli Lilly halted human testing of a COVID-19 treatment citing a potential safety concern. A person familiar with the trial told CBS News the pause will last approximately two weeks.

The treatment, which uses COVID-19 antibodies, is similar to a therapeutic given to President Donald Trump that he touted as a cure. “It was like unbelievable,” Mr. Trump said. “I felt good immediately.”

This comes as Johnson & Johnson said its vaccine trial, the largest to date, is also stopping temporarily while it investigates if an unexplained illness was caused by its vaccine.

CBS News medical contributor Dr. David Agus said these pauses are routine and reassuring.

“So this is not unusual,” Agus said. “I hope that Americans see news like this and have comfort that we are investigating every single issue with these drugs and with these vaccines to make sure they are safe for the American people.”

Thirty-seven states are seeing a rise in average new cases; only one state — South Carolina — is down. A key driver is gatherings. A recent CDC report found that a 13-year-old girl infected 11 people staying at the same house during a family vacation, without masks or social distancing.

With many Americans resisting guidelines, the death toll continues to grow. Leanna Richardson lost her mother — a third-grade teacher from North Carolina — in just 10 days.

“And if anything else, let her death be a reminder that COVID-19 doesn’t care,” Richardson said. “COVID-19 is serious. This is a pandemic. This is not a joke.”

School officials at her mother’s school said they do not believe she contracted the virus at work where she was teaching students in person. 

© 2020 CBS Interactive Inc. All Rights Reserved.

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Johnson & Johnson Pauses Coronavirus Vaccine Trials due to ‘Unexplained Illness’ in Participant | Health News

Johnson & Johson has paused the clinical trial for its coronavirus vaccine following an “unexpected illness” in a participant.

Health experts have said that pauses in vaccine trials aren’t uncommon and mean that safety precautions are working. It’s the second vaccine trial to be paused in the U.S. A vaccine from AstraZeneca and Oxford University was put on pause last month after a participant fell ill. That trial hasn’t yet resumed in the U.S.

Photos: Daily Life, Disrupted

TOPSHOT - A passenger in an outfit (R) poses for a picture as a security guard wearing a facemask as a preventive measure against the Covid-19 coronavirus stands nearby on a last century-style boat, featuring a theatrical drama set between the 1920s and 1930s in Wuhan, in Chinas central Hubei province on September 27, 2020. (Photo by Hector RETAMAL / AFP) (Photo by HECTOR RETAMAL/AFP via Getty Images)

It is unclear how long Johnson & Johnson’s pause could last. The company said there is a “significant distinction” between a study pause and a regulatory hold of a clinical trial, which could last much longer.

“We must respect this participant’s privacy. We’re also learning more about this participant’s illness, and it’s important to have all the facts before we share additional information,” the company said in a press release Monday night.

The vaccine’s phase three trial launched last month, making it the fourth vaccine candidate to reach final stage trials in the U.S. The company at the time said it plans to enroll up to 60,000 volunteers at more than 200 clinical research sites in the U.S. and other countries. The vaccine was developed by Belgium-based Janssen Pharmaceutical Companies, which is a subsidiary of Johnson & Johnson.

The vaccine requires just one dose, making it logistically easier to produce and roll out than one that requires two doses with time in between each injection.

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J&J Pauses Coronavirus Vaccine Trials Due to Unexplained Illness | Top News

(Reuters) – Johnson & Johnson

has paused clinical trials of its coronavirus vaccine candidate due to an unexplained illness in a study participant, delaying one of the highest profile efforts to contain the global pandemic.

The move comes around a month after AstraZeneca

also suspended trials of its experimental coronavirus vaccine – which uses a similar technology – due to a participant falling ill.

J&J said on Monday the illness was being reviewed by an independent data and safety monitoring board as well as the U.S. group’s clinical and safety physicians.

The company, which reports quarterly financial results on Tuesday morning, said such pauses are normal in big trials, which can include tens of thousands of people.

It added the voluntary “study pause” in giving doses of the vaccine candidate was different from a “regulatory hold” imposed by health authorities.

AstraZeneca last month paused late-stage trials of its experimental coronavirus vaccine developed with the University of Oxford due to an unexplained illness in a British study participant.

While AstraZeneca’s trials in Britain, Brazil, South Africa and India have since resumed, its U.S. trial is still on hold, pending a regulatory review.

The J&J and AstraZeneca vaccines are both based on a so-called adenovirus, a harmless modified virus that instructs human cells to produce vaccine proteins.

They are both also part of the U.S. government’s Operation Warp Speed programme to support vaccine development.

“This could be a second case of adenoviral vaccine to spur safety concerns,” said Bryan Garnier analyst Olga Smolentseva.

AstraZeneca and medical experts say trial suspensions to look into the cause of a participant’s illness are not uncommon. Underwriters of clinical trial insurance have said premiums for coronavirus vaccines studies are only marginally higher than for pre-pandemic vaccines.

J&J on Sept. 22 became the fourth Warp-Speed participant to enter the final stage of testing on humans, with the aim of enrolling 60,000 volunteers in the United States and abroad.”Everybody is on the alert because of what happened with AstraZeneca,” Dr. William Schaffner, a professor of infectious diseases at the Vanderbilt University School of Medicine, said by email, adding it could take a week to gather information.

“This is likely to be a neurological event,” he said. Last month, J&J said its vaccine candidate produced a strong immune response in an early-to-mid stage clinical trial. This prompted the company to start the large scale trial, with results expected by the end of this year or early 2021.

J&J declined to elaborate on the illness due to privacy concerns. It did say some participants in studies get placebos, and it was not always clear whether a person suffering a serious adverse event in a trial received a placebo or the treatment.

Stat News reported https://www.statnews.com/2020/10/12/johnson-johnson-covid-19-vaccine-study-paused-due-to-unexplained-illness-in-participant/?utm_content=buffer37312&utm_medium=social&utm_source=twitter&utm_campaign=twitter_organic the pause earlier, citing a document sent to outside researchers, which stated that a “pausing rule” had been met, the online system used to enroll patients in the study had been closed and the data and safety monitoring board would be convened.

(Reporting by Ayanti

Gossamer Bio Announces Topline Results for Phase 2 Trials of Oral GB001 in Asthma and Chronic Rhinosinusitis

– Primary endpoint of asthma worsening not met in LEDA Study, however consistent numeric reductions ranging from 32-35% observed across all three GB001 groups –

– Statistically significant improvements in key secondary endpoint of time to first asthma worsening of 28% and 30% observed for 20 mg and 60 mg doses of GB001, respectively; 23% improvement observed in 40 mg group –

– TITAN Study in chronic rhinosinusitis did not meet primary or secondary endpoints –

– Gossamer to hold webcast to discuss trial results at 8:00 am EDT –

Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, today announced topline results from its Phase 2b LEDA trial in patients with moderate-to-severe eosinophilic asthma and its Phase 2 TITAN trial in patients with chronic rhinosinusitis.

“While we did not achieve statistical significance on the primary endpoint in the LEDA Study, we are encouraged by the consistent results observed for all three doses of once-daily, oral GB001 therapy across the primary and secondary endpoints,” said Sheila Gujrathi, M.D., Co-Founder and Chief Executive Officer of Gossamer. “We believe these data provide important information for designing a well-powered Phase 3 program for GB001 in severe asthma. We plan to engage in global regulatory discussions in order to inform our thinking around potential partnerships or strategic alternatives for this program.”

“The results of the robust LEDA Study are meaningful and help us to further understand the DP2 pathway in asthma,” said Bruce Levy, M.D., Chief, Division of Pulmonary and Critical Care Medicine at Brigham and Women’s Hospital and Professor of Medicine at Harvard Medical School. “I believe GB001 as an oral treatment has the potential to serve the high unmet need of patients with uncontrolled severe asthma.”

LEDA Phase 2b Trial Design

The LEDA trial enrolled 480 patients with uncontrolled, moderate-to-severe eosinophilic asthma and assessed the effect of oral GB001 add-on therapy to standard of care over 24 weeks, comparing three dose groups of once-daily, oral GB001 (20 mg, n=120; 40 mg, n=118; and 60 mg, n=122) to placebo (n=120).

The primary endpoint, asthma worsening, included five components and was chosen for its sensitivity in detecting deterioration in clinical outcome measures known to be correlated with exacerbations. A patient was considered to have experienced asthma worsening if they met any of the five components by Week 24. This endpoint has previously been used in the context of steroid withdrawal studies, including a prior Phase 2 trial of GB001.

LEDA Primary and Secondary Endpoint Results

The primary endpoint of the trial was not met, though consistent and meaningful numeric reductions in the odds of asthma worsening as compared to placebo were observed across all GB001 groups: 33% (p=0.1425), 32% (p=0.1482), and 35% (p=0.1086), for the GB001 20 mg, 40 mg, and 60 mg groups, respectively. In addition, statistically significant improvements in the key secondary endpoint of time to first asthma worsening as compared to placebo

J&J pauses coronavirus vaccine trials due to unexplained illness

(Reuters) – Johnson & Johnson JNJ.N has paused clinical trials of its coronavirus vaccine candidate due to an unexplained illness in a study participant, delaying one of the highest profile efforts to contain the global pandemic.

The move comes around a month after AstraZeneca AZN.L also suspended trials of its experimental coronavirus vaccine – which uses a similar technology – due to a participant falling ill.

J&J said on Monday the illness was being reviewed by an independent data and safety monitoring board as well as the U.S. group’s clinical and safety physicians.

The company, which reports quarterly financial results on Tuesday morning, said such pauses are normal in big trials, which can include tens of thousands of people.

It added the voluntary “study pause” in giving doses of the vaccine candidate was different from a “regulatory hold” imposed by health authorities.

AstraZeneca last month paused late-stage trials of its experimental coronavirus vaccine developed with the University of Oxford due to an unexplained illness in a British study participant.

While AstraZeneca’s trials in Britain, Brazil, South Africa and India have since resumed, its U.S. trial is still on hold, pending a regulatory review.

The J&J and AstraZeneca vaccines are both based on a so-called adenovirus, a harmless modified virus that instructs human cells to produce vaccine proteins.

They are both also part of the U.S. government’s Operation Warp Speed programme to support vaccine development.

“This could be a second case of adenoviral vaccine to spur safety concerns,” said Bryan Garnier analyst Olga Smolentseva.

AstraZeneca and medical experts say trial suspensions to look into the cause of a participant’s illness are not uncommon. Underwriters of clinical trial insurance have said premiums for coronavirus vaccines studies are only marginally higher than for pre-pandemic vaccines.

J&J on Sept. 22 became the fourth Warp-Speed participant to enter the final stage of testing on humans, with the aim of enrolling 60,000 volunteers in the United States and abroad.”Everybody is on the alert because of what happened with AstraZeneca,” Dr. William Schaffner, a professor of infectious diseases at the Vanderbilt University School of Medicine, said by email, adding it could take a week to gather information.

“This is likely to be a neurological event,” he said. Last month, J&J said its vaccine candidate produced a strong immune response in an early-to-mid stage clinical trial. This prompted the company to start the large scale trial, with results expected by the end of this year or early 2021.

J&J declined to elaborate on the illness due to privacy concerns. It did say some participants in studies get placebos, and it was not always clear whether a person suffering a serious adverse event in a trial received a placebo or the treatment.

Stat News reported here the pause earlier, citing a document sent to outside researchers, which stated that a “pausing rule” had been met, the online system used to enroll patients in the study had been closed and the data and safety monitoring board would be convened.

Reporting

Johnson & Johnson pauses clinical trials for a Covid vaccine over patient illness

Johnson & Johnson has paused its clinical trials for a Covid-19 vaccine following a patient illness, just weeks after it announced it was in its final stage.

A pause is not entirely unexpected in vaccine trials. When another vaccine trial was temporarily stopped last month, experts hailed the move, pointing to it as an example of the scientific rigor that is being maintained despite the understandably intense public interest for a Covid-19 vaccine.

The Johnson & Johnson trial was paused after an “unexplained” illness in one of its participants and in compliance with regulatory standards, the company said in a news release Monday night. The pharmaceutical company said the patient’s condition was being reviewed and evaluated by the ENSEMBLE independent Data Safety Monitoring Board.

“We must respect this participant’s privacy,” the company’s statement said. “We’re also learning more about this participant’s illness, and it’s important to have all the facts before we share additional information.”

It’s unclear whether the patient received the experimental vaccine or were in the placebo-control group.

AstraZeneca also started its Phase 3 vaccine trial last month but was placed on pause in the U.S. after a participant in the United Kingdom was reported to have developed a spinal cord injury. The company resumed its trial with Oxford University in the U.K. but was awaiting Food and Drug Administration approval to continue in the U.S.

Dr. Francis Collins, director of the National Institutes of Health, told NBC News last month that the pause should reassure those with concerns about possible vaccine safety issues.

“If anybody thinks we’re just glossing over these kinds of issues in the big rush to approve a vaccine, this ought to be reassuring,” Collins said during a “Doc to Doc” interview with NBC News medical correspondent Dr. John Torres, which was streamed on Facebook.

Pfizer and Moderna also have vaccine trials that went into Phase 3 in July, both of which require two doses about a month apart. The Johnson & Johnson vaccine is instead administered in one dose, avoiding the complicated coordination to require that people return in time for the second dose.

Johnson & Johnson announced last week that European Commission approved an advance purchase agreement from its parent company, Janssen Pharmaceutical Companies, for 200 million doses of the vaccine to E.U. member states following approval. The company also said it was looking to allocate up to 500 million vaccine doses toward international efforts for low-income nations.

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As Globe Gallops Into Vaccine Trials, Insurers Remain Unfazed | Top News

By Noor Zainab Hussain, Carolyn Cohn and Ludwig Burger

LONDON/FRANKFURT (Reuters) – The world is racing towards a vaccine in record time, stirring public concerns about safety to the extent that nine leading developers have felt compelled to issue a pledge to uphold scientific standards and testing rigour.

Yet, while more than 40 experimental COVID-19 vaccines are being tested on humans, the insurance companies with decades of experience in assessing the risks of clinical trials don’t see anything to be unduly concerned about.

Executives at insurer Allianz and brokers Gallagher and Marsh, among the leading players in clinical trials insurance, told Reuters that premiums had only marginally increased so far in the current pandemic.

They argued there was little structural difference to trials carried out in the past, despite drugmakers around the world competing to shatter the fastest time in history for developing a vaccine, which stands at around four years.

“Rates have been relatively stable. Even this year we have so far seen only moderate price increases on average, with higher price jumps for particularly exposed COVID-19 trials,” said Mark Piazzi, senior underwriter liability at Allianz Global Corporate & Specialty (AGCS).

This was echoed by David Briggs, managing director, life sciences practice at Gallagher, who said every trial was rated on its methods and the kinds of patients involved.

Gallagher said premiums in Britain, for example, started at about 5,000 pounds ($6,500) per trial.

Total claims limits in policies were typically set at roughly $6-12 million, depending on the country’s rules, according to several insurance companies interviewed by Reuters.

In Britain, for instance, claim limits were usually set at no lower than 5 million pounds, while in Germany the figure was around 10 million euros ($11.8 million).

‘LOSS EXPERIENCE NOT DRAMATIC’

However part of the reason why premiums have not risen as sharply as some people might have expected is that claims from trial are generally uncommon, according to executives. This is because patients have often signed so-called informed consent agreements, they said.

Jim Walters, managing director of Life Sciences & Chemical Group at broker Aon, said such agreements outlined the risks that patients were taking by participating in the trial.

“So, you know, everything from you could have a sore spot on your arm. To you could potentially die. And you know, they would literally go that far in some of these protocols,” he added.

“Those generally tend to hold up in courts and in legal systems around the world. That means that the loss experience coming out of clinical trials is not very dramatic.”

Claims are often limited to circumstances linked to the improper conduct of trials or any wrongdoing, rather than side-effects of the treatment, executives said.

Such have been the worries about the vaccine race among some members of the public, who fear safety standards could slip, that nine developers issued a joint pledge last month to “uphold the integrity of the scientific process”.

ASTRAZENECA TRIAL SUSPENSION

AstraZeneca and Oxford University’s suspension of global Phase