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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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Taysha Gene Therapies Receives Rare Pediatric Disease Designation and Orphan Drug Designation for TSHA-102 as a Treatment for Rett Syndrome

Program leverages novel miRARE platform technology used to control transgene expression on a cellular basis

TSHA-102 anticipated to submit Investigational New Drug application in 2021

Taysha Gene Therapies Inc. (Nasdaq: TSHA), a patient-centric gene therapy company focused on developing and commercializing AAV-based gene therapies for the treatment of monogenic diseases of the central nervous system in both rare and large patient populations, today announced that it has received rare pediatric disease designation and orphan drug designation from the U.S. Food and Drug Administration (FDA) for TSHA-102, an AAV9-based gene therapy in development for the treatment of Rett syndrome. Taysha anticipates that it will submit an Investigational New Drug (IND) application for TSHA-102 to the FDA in 2021.

Rett syndrome is one of the most common genetic causes of severe intellectual disability worldwide, with a prevalence of over 25,000 cases in the U.S. and European Union (EU). It is an X-linked disease that primarily occurs in females, but it can be seen very rarely in males. It is usually recognized in children between six to 18 months of age as they begin to miss developmental milestones or lose abilities they had developed. Individuals with Rett syndrome also show symptoms that include loss of speech, loss of purposeful use of hands, loss of mobility, seizures, cardiac impairments, breathing issues and sleep disturbances.

“Patients with Rett syndrome are currently managed with symptomatic treatments as there are no therapies approved to treat the underlying cause of disease,” said Berge Minassian, M.D., Chief Medical Advisor of Taysha and Chief of Pediatric Neurology at the University of Texas Southwestern Medical Center (UT Southwestern). Dr. Minassian is credited with describing the CNS isoform of the MECP2 gene which is responsible for neuronal and synaptic function throughout the brain. “Gene therapy offers a potentially curative option for patients suffering with Rett syndrome.”

Rett syndrome is caused by mutations in the MECP2 gene. TSHA-102 is designed to deliver a healthy version of the MECP2 gene as well as the miRNA-Responsive Auto-Regulatory Element, miRARE, platform technology to control the level of MECP2 expression. “TSHA-102 represents an important step forward in the field of gene therapy, where we are leveraging a novel regulatory platform called miRARE to prevent the overexpression of MECP2,” said Steven Gray, Ph.D., Chief Scientific Advisor of Taysha and Associate Professor in the Department of Pediatrics at UT Southwestern. “In collaboration with Sarah Sinnett, Ph.D. to develop miRARE, our goal was to design a regulated construct that allowed us to control MECP2 expression to potentially avoid adverse events that are typically seen with unregulated gene therapies.”

The FDA defines a rare pediatric disease as a serious or life-threatening disease in which the disease manifestations primarily affect individuals aged from birth to 18 years. Pediatric diseases recognized as “rare” affect under 200,000 people in the U.S. The Rare Pediatric Disease Priority Review Voucher Program is intended to address the challenges that drug companies face when developing treatments for these unique patient populations. Under this program, companies are

Eli Lilly pauses trial of antibody drug Trump touted as COVID-19 ‘cure’ over safety concern

By Michael Erman and Carl O’Donnell

(Reuters) – Eli Lilly and Co said on Tuesday that the government-sponsored clinical trial of its COVID-19 antibody treatment similar to one taken by U.S. President Donald Trump has been paused because of a safety concern.

Trump touted the Lilly drug, along with the antibody treatment from Regeneron Pharmaceuticals Inc that he received for his COVID-19, as tantamount to a cure in a video he posted last week.

The announcement comes one day after Johnson & Johnson said it was forced to pause a large high-profile trial of its experimental coronavirus vaccine because a volunteer fell ill. J&J said it does not yet know if that person was given the vaccine or a placebo.

AstraZeneca Plc’s U.S. trial for its experimental COVID-19 vaccine has also been on hold for over a month after a volunteer in its UK study fell ill. Trials of that vaccine resumed in other regions after a brief halt.

Lilly said earlier this month it was applying for emergency use authorization (EUA) for the antibody drug, LY-CoV555, for patients with mild to moderate COVID-19 based on data from another clinical trial.

It is not uncommon to pause drug trials to investigate safety concerns, and such actions do not necessarily indicate a serious problem. Because of the urgent need for drugs and vaccines to tackle a pandemic that has claimed over 1 million lives worldwide – and the speed with which they are being developed – these trials have come under intense scrutiny.

“Out of an abundance of caution, the ACTIV-3 independent data safety monitoring board (DSMB) has recommended a pause in enrollment,” Lilly spokeswoman Molly McCully said in an emailed statement. “Lilly is supportive of the decision by the independent DSMB to cautiously ensure the safety of the patients participating in this study.”

The Indianapolis-based drugmaker did not comment on the implications for the paused trial, called ACTIV-3, which is testing the treatment on COVID-19 patients who require hospitalization, or on its other ongoing trials. 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 and the National Institutes of Health did not immediately reply to requests for comment.

Lilly began its ACTIV-3 trial in August and is aiming to recruit 10,000 patients primarily in the United States.

The trial compares patients who receive its antibody drug plus Gilead Sciences Inc’s antiviral drug remdesivir with those who receive remdesivir alone.

Lilly sought the EUA from U.S. regulators after publishing data in September showing LY-CoV555 helped cut hospitalization and emergency room visits for COVID-19 patients. The treatment is being developed with Canadian biotech AbCellera.

Lilly shares closed nearly 3%.

(Reporting by Michael Erman and Carl O’Donnell in New York; Additional reporting by Deena Beasley in Los Angeles; Editing by Bill Berkrot)

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FDA faults quality control at Lilly plant making Trump-touted COVID drug

By Dan Levine and Marisa Taylor

(Reuters) – U.S. drug inspectors uncovered serious quality control problems at an Eli Lilly and Co pharmaceutical plant that is ramping up to manufacture one of two promising COVID-19 drugs touted by President Trump as “a cure” for the disease, according to government documents and three sources familiar with the matter.

The Lilly antibody therapy, which is experimental and not yet approved by regulators as safe and effective, is similar to a drug from Regeneron Pharmaceuticals that was given to the president during his bout with COVID-19.

Trump, who credits the Regeneron drug with speeding his recovery, has called for both therapies to become available immediately on an emergency basis, raising expectations among some scientists and policy experts that the administration will imminently release an Emergency Use Authorization (EUA) for the drug. The president’s push is key to his efforts to convince voters he has an answer to the pandemic that has killed more than 215,000 Americans.

But the findings by the U.S. Food and Drug Administration inspectors at the Lilly manufacturing facility, which have not been disclosed previously, could complicate the drugmaker’s bid for a so-called emergency use authorization (EUA) from the federal agency, two of the sources and two outside legal experts told Reuters. That’s because U.S. law generally requires compliance with manufacturing standards for authorization of a drug.

The three sources who spoke to Reuters requested that their names be withheld so they could speak freely without fear of retaliation.

Inspectors who visited the Lilly plant in Branchburg, New Jersey, last November found that data on the plant’s various manufacturing processes had been deleted and not appropriately audited, government inspection documents show.

“The deleted incidents and related audit trail were not reviewed by the quality unit,” the FDA inspectors wrote. Because the government inspection documents reviewed by Reuters were heavily redacted by the FDA it was not possible to see the inspectors’ more specific findings.

Following its November inspection, the FDA classified the problems as the most serious level of violation, resulting in an “Official Action Indicated” (OAI) notice.

That “means that the violations are serious enough and have a significant enough impact on the public health that something needs to be fixed,” said Patricia Zettler, a former associate chief counsel at the FDA who is now a law professor at Ohio State University.

Separately, Lilly said on Tuesday it had paused its clinical trial for the COVID drug in hospitalized patients “out of an abundance of caution” over a potential safety concern. The company did not release information on what the problem was and declined to say how the news might affect their EUA request.

In response to Reuters’ questions on Monday about the manufacturing issues, Lilly confirmed the OAI notice but declined to provide details on what prompted the FDA action. The drugmaker said it has launched a “comprehensive remediation plan,” has increased staffing at the site and was working “aggressively” to address all concerns raised during

Advocates Stand Up Against AstraZeneca to Save Drug Discount Program for Vulnerable Populations

Wilmington Protest, Wed., Oct. 14th – 12 noon – 1:00 pm ET

Dozens of concerned healthcare advocates from across the northeast region protest AstraZeneca, one of five U.S. based pharmaceutical companies that have cut back on the number of drugs they provide through the 340B federal drug discount program

Please replace the release with the following updated version due to multiple revisions.

The updated release reads:

DELAWARE PROTEST: ADVOCATES STAND UP AGAINST ASTRAZENECA TO SAVE DRUG DISCOUNT PROGRAM FOR VULNERABLE POPULATIONS

Wilmington Protest, Wed., Oct. 14th – 12 noon – 1:00 pm ET

Dozens of concerned healthcare advocates from across the northeast region protest AstraZeneca, one of five U.S. based pharmaceutical companies that have cut back on the number of drugs they provide through the 340B federal drug discount program.

Healthcare advocates from across the northeast region will protest the recent actions of AstraZeneca, in cutting back the number of critical life-saving drugs provided at discounted rates to non-profit healthcare providers, through the federal 340B drug discount program.

WHAT:

Protest against AstraZeneca

 

 

WHERE:

AstraZeneca’s Corporate Office

 

1800 Concord Pike, Wilmington, DE 19803

 

NOTE: The protest will take place at the intersection of Powder Mill Road & Route 22

 

 

WHEN:

Tomorrow, Wednesday, October 14, 2020

 

12noon – 1pm (EDT)

 

 

WHO:

Healthcare advocates from across the Northeast Region

The federal 340B Drug Discount Program is a lifeline that allows safety net providers, including HIV/AIDS clinics receiving funding through the Ryan White program, to obtain prescription drugs at below-retail prices. The program was established with bipartisan support as part of the Veterans Health Care Act of 1992. With 340B savings, Ryan White clinics are able to stretch their grant funds, offer a wider range of services, and improve the quality of care persons living with HIV/AIDS receive. The program also benefits qualified 340B covered entities such as non-profit rural health facilities, community clinics and children’s hospitals that serve vulnerable populations.

Tomorrow’s protest, led by healthcare advocates from AIDS Healthcare Foundation (AHF), follows a lawsuit filed by Ryan White Clinics for 340B Access (RWC-340B) against the U.S. Department of Health and Human Services (HHS), in U.S. District Court for the District of Columbia, to require the HHS secretary to take action against AstraZeneca and three other pharmaceutical companies, including Eli Lilly, Novartis and the U.S. division of Sanofi-Aventis which are illegally withholding drugs they are required to sell through the 340B program. With tomorrow’s protest, AHF is demanding that these greedy pharmaceutical companies stop their bullying tactics that will have a devastating impact on the healthcare and well-being of our most vulnerable populations (see LITIGATION PRESS RELEASE). RWC340B also recently released a study on the potential adverse impact of policies reducing resources to Ryan White clinics, see WHITE PAPER, PRESS RELEASE, and FACT SHEET.

“AstraZeneca has launched an assault on a federal drug discount program essential to the safety net of our nation’s health care,” stated John Hassell, AHF’s national director of advocacy. “They are messing with the numerous health care centers

Davina McCall compares menopause to being a drug addict

Davina McCall attending The Masked Singer press launch held at The Mayfair Hotel, London. (Photo by Scott Garfitt/PA Images via Getty Images)
Davina McCall attending The Masked Singer press launch held at The Mayfair Hotel, London. (Photo by Scott Garfitt/PA Images via Getty Images)

TV presenter Davina McCall has revealed going though the menopause took her back to the days she was a drug addict.

The former Big Brother host has been clean for many years, but admits going through perimenopause eight years ago aged 44 gave her similar symptoms to when she was using Class A drugs.

The 52-year-old spoke of the experience as part Loose Women Menopause Week when she appeared on the ITV show on Monday (12 October).

Read more: Changing Rooms to return with Davina McCall as host

McCall admitted she had no idea what was happening when she started having symptoms such as night sweats and being moody.

She said: “Nobody told me about it. I hadn’t learned about it at school, from my mum or my big sister. It was the thing nobody talked about it.

Watch: Davina McCall talks about the menopause on Loose Women

“There was so much shame about it. It was a sign you’d dried up, you were past your sell by date, you were at the end of your life, which in Victorian days, I suppose you were….But now we live until we’re 80, we’re right in the middle of our lives.

“This is where the good bit happens where we know we’re not going to have kids anymore and we can go off and be a bit selfish after being selfless for so long.”

Comparing the symptoms to those similar to being an addict, she added: “Obviously I’m a reformed addict and I was waking up soaked in sweat, having to put towels on the bed, thinking, ‘There’s something wrong with me, I’ve got the flu or a virus or something’.

LONDON, ENGLAND - NOVEMBER 12: Davina McCall attends the ITV Palooza 2019 at The Royal Festival Hall on November 12, 2019 in London, England. (Photo by Lia Toby/Getty Images)
Davina McCall attends the ITV Palooza 2019 at The Royal Festival Hall on November 12, 2019 in London, England. (Photo by Lia Toby/Getty Images)

“It really reminded me of when I was using and I really hated it… and mood swings, shouting at the kids. I’m not a shouty mother at all and then I’d end up crying in the car, apologising to the children, going, ‘I’m really sorry, I don’t know what’s wrong with me.’

“My keys were in the fridge, my phone was in the bin, my libido was through the floor. It was just a nightmare.

Read more: Davina McCall shares emotional message about lockdown ‘rollercoaster’

“The symptoms were few and far between. My periods were regular, but sometimes they were a bit longer, sometimes a bit shorter. I didn’t think I could have it so early… but actually it’s the perimenopause.”

McCall also how Hormone Replacement Therapy has helped her get through it. “The health benefits for me way outweighed the negatives. I’ve got dementia running in my family, it massively reduces that, reduces diabetes and it reduces the risk of heart disease by 50 per cent.”

Loose Women is on weekdays from 12:30pm on

South Korea’s Celltrion gets approval for Phase 3 trials of COVID-19 antibody drug

By Sangmi Cha

SEOUL (Reuters) – South Korean drugmaker Celltrion Inc <068270.KS> said on Monday it has received regulatory approval for Phase 3 clinical trials of an experimental COVID-19 treatment.

The approval comes as the company plans to seek conditional approval for its antibody drug, CT-P59, for emergency use by the end of this year.

The treatment, the most advanced antibody drug in terms of research in South Korea, is directed against the surface of the virus and designed to block it from locking on to human cells.

The third stage trials will be conducted on some 1,000 asymptomatic coronavirus patients and those who have come into close contact with COVID-19 patients in Korea, Celltrion said in a statement.

The Ministry of Food and Drug Safety recently approved a Phase 2/3 study on patients with mild and moderate cases of COVID-19, Lee Sang-joon, Celltrion’s senior executive vice president, told Reuters.

Celltrion began commercial production of the drug in September – likely to amount to around 1 million doses – in anticipation of demand in both domestic and overseas markets.

In July, Celltrion separately launched overseas human trials of its treatment in Britain.

(Reporting by Sangmi Cha; Editing by Kenneth Maxwell)

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Hong Kong scientists say anti-microbe drug successful against coronavirus

An affordable anti-microbial drug used to treat stomach ulcers and bacterial infections has shown promise in combatting the coronavirus in animals, scientists in Hong Kong announced Monday.

Researchers set out to explore whether metallodrugs — compounds containing metal that are more commonly used against bacteria — might also have anti-viral properties that could fight the SARS-CoV-2 coronavirus.

Using Syrian hamsters as tests subjects, they found that one of the drugs, ranitidine bismuth citrate (RBC), was “a potent anti-SARS-CoV-2 agent”.

“RBC is able to lower the viral load in the lung of the infected hamster by tenfold,” Hong Kong University researcher Runming Wang told reporters on Monday as the team presented their study.

“Our findings demonstrate that RBC is a potential anti-viral agent for Covid-19.”

The coronavirus has killed more than a million people since it first emerged in China last December and then spread across the globe.

As scientists scramble to find a vaccine, they have also been scouring readily available drugs that might alleviate symptoms caused by the Covid-19 disease or help the body fight infection.

Remdesivir, a broad-spectrum antiviral drug, and dexamethasone, a type of corticosteroid, have both been identified as having some success against the virus. Both were used by doctors to treat US President Donald Trump after he contracted Covid-19.

But they have drawbacks.

Remdesivir is expensive and there is a global shortage while dexamethasone has immunosuppression effects that are risky for all but the most ill patients. Other drug cocktails have shown liver damage can be a risk.

The Hong Kong scientists said RBC was a commonly available drug used against stomach ulcers with a safe and comprehensive pharmacological profile.

“It’s been used for decades so it’s pretty safe,” Wang said.

They added that their research, which has been published in the journal Nature Microbiology, suggested other metallodrugs might also have success against the virus and should be further explored.

jta/qan

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Regeneron CEO says $450 million contract with U.S. secured 300k doses of antibody drug

Washington — Dr. Leonard Schleifer, the founder and CEO of Regeneron Pharmaceuticals, which developed the antibody cocktail heralded by President Trump, estimated Sunday that a $450 million contract the company won from the federal government over the summer will secure roughly 300,000 doses of the treatment.

“They bought from us several hundred thousand, maybe around 300,000 doses, which they are going to make it for free,” Schleifer said in an interview with “Face the Nation.” “We can’t do this alone. We need the entire industry.”

The Trump administration announced in July it signed a $450 million contract with Regeneron to supply the treatment. But with the number of new coronavirus cases outpacing the doses of the drug available, Schleifer conceded the federal government, together with ethics experts at the Food and Drug Administration, will have to decide who receives the limited supply.

“Coming up with a distribution system where we take what’s limited, and we try and give it to the people who most need it, who would most benefit from it — the vulnerable people, elderly people, people who are at high risk, household contacts perhaps,” he said. “We have to figure out ways to ration this.”

Mr. Trump was given a single dose of Regeneron’s antibody cocktail while he was being treated for COVID-19 and has gone on to praise the treatment, officially known as REGN-COV2, as a “cure” for the virus.

But the treatment has yet to undergo a peer-reviewed drug trial and has only been given to 10 people outside of clinical trials.

Schleifer called Mr. Trump’s case a “case report” and said while it is evidence of how the drug worked, it’s the “weakest evidence that you can get.”

“The real evidence has to come — about how good a drug is and what it will do on average — has to come from these large clinical trials, these randomized clinical trials, which are the gold standard,” he said.

Regeneron applied for an emergency use authorization from the FDA, and if it’s granted, the government has agreed “to making these doses available to the American people at no cost.”

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Gilead Drug Shows Promising Results In Treating COVID, Ready For Distribution Says CEO

KEY POINTS

  • Gilead’s coronavirus treatment redemsivir was found to reduce recovery time in patients by several days
  • Redemsivir and other drug treatments could serve as stopgap measures until a proper vaccine is ready and approved
  • The Trump administration and Congress re-entered negotiations about a stimulus package to help a U.S. economy hit hard by the pandemic

Final results from Gilead Sciences’ latest remdesivir trial showed the antiviral drug was effective in treating coronavirus patients and cutting recovery time by at least a week.

Gilead’s CEO said, given the positive results, the company was ready for mass production and distribution of the drug.

As of Friday, Johns Hopkins said the U.S. has over 7.6 million confirmed cases of coronavirus and 212,805 reported deaths from it. The latest trial was conducted for nearly a month and involved over 1,062 patients hospitalized for coronavirus. Half of the patients were given remdesivir while the other half were given placebo as part of the randomized, double-blind trial. Trial sites were located in the U.S., United Kingdom, Denmark, Mexico, Japan, Germany, Greece, Korea, Spain, and Singapore.

Average recovery time for people given remdesivir was found to be shortened by five days. While overall data showed the drug was not significant in reducing mortality, it appeared effective in lowering the mortality rate among patients on oxygen.

“Our data show that remdesivir was superior to placebo in shortening the time to recovery in adults who were hospitalized with COVID-19 and had evidence of lower respiratory tract infection,” the final report in the New England Journal of Medicine said.

Gilead CEO Daniel O’Day said the company was pleased with the results and ready for distribution, if and when the drug is approved.

“These results are meaningful,” O’Day told CNBC. “They’ll definitely help patients around the world who have the misfortune of entering the hospital to get better, and I’m really pleased to say that we have ample supply.”

Former Food and Drug Administration Commissioner Dr. Scott Gottlieb said while remdesivir, alone, is likely not enough to treat coronavirus, this data is a good sign in battling the pandemic.

“I think combined with the antibody drugs, which should be coming onto the market soon based on the data that we’ve seen, this is a pretty effective treatment regime in advance of a vaccine,” Gottlieb told CNBC.

While a drug like remdesivir, or the antibody treatment developed by Eli Lilly, serve as a stopgap means of addressing coronavirus, a vaccine will still be needed to serve as a long-term answer. The hope is that a vaccine will be approved and ready for distribution by the end of December, with timetables having life get back to some degree of normalcy by summer 2021.

Some of the vaccines furthest along include:

  • Moderna and the National Institute of Health’s mRNA vaccine, currently in Phase 3 trials
  • China’s CanSino Biologics and Russia’s Gamaleya Research Institute have vaccines in limited approval, though experts warned these were likely rushed and could still be harmful
  • AstraZeneca and the