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Beyond Celiac Chosen by 9 Meters Biopharma as Exclusive Patient Organization to Recruit for First-Ever Phase 3 Clinical Trial

Premier Patient Recruiter for Celiac Disease Research, Beyond Celiac Taps Extensive Network to Advance Study

Go Beyond Celiac, an online patient database launched in 2017, allows its thousands of users to participate in research by sharing their celiac disease stories and experiences and learn how to become involved in research studies such as the Phase 3
Go Beyond Celiac, an online patient database launched in 2017, allows its thousands of users to participate in research by sharing their celiac disease stories and experiences and learn how to become involved in research studies such as the Phase 3
Go Beyond Celiac, an online patient database launched in 2017, allows its thousands of users to participate in research by sharing their celiac disease stories and experiences and learn how to become involved in research studies such as the Phase 3

Philadelphia, PA, Oct. 14, 2020 (GLOBE NEWSWIRE) — Beyond Celiac, the leading catalyst for a celiac disease cure in the United States, today announced it has been chosen by 9 Meters Biopharma, Inc. (Nasdaq: NMTR) as the exclusive patient organization to recruit for the first-ever Phase 3-stage clinical trial therapeutic for treatment of celiac disease. Beyond Celiac will use its unrivaled connection to the celiac disease community and its powerful online patient database to recruit participants for the study of larazotide acetate, which aims to address leaky gut in celiac disease.

“We really listen to our community’s wants and needs. Because of our extensive connection to the people and commitment to connecting researchers with our community, Beyond Celiac has become the partner of choice for leading biotechnology and pharmaceutical companies such as 9 Meters,” said Beyond Celiac CEO Alice Bast. “This is the furthest a celiac disease clinical trial has gone, and it’s an exciting opportunity for our organization to play a vital role in fulfilling its promise.”

9 Meters Biopharma is evaluating larazotide acetate for celiac disease patients who continue to experience gastrointestinal symptoms while following a gluten-free diet. Designed to tighten junctions between intestinal cells, larazotide acetate would act like shoelaces to help restore leaky junctions to a normal state and would be used in addition to the gluten-free diet. It is being tested at more than 100 clinical sites, with a goal of 525 study participants. Results are expected by the end of 2021.

By partnering with Beyond Celiac for recruitment, 9 Meters Biopharma now has access to the power of Go Beyond Celiac, a secure online patient database with thousands of users who share their celiac disease stories and experiences with researchers and seek to become involved in studies.

“Our conservative estimate is that our celiac disease program is at least two years ahead of everyone else’s,” said John Temperato, president and CEO of 9 Meters Biopharma. “Beyond Celiac is going to help us across the finish line in developing the effective treatments that celiac patients deserve.”

Celiac disease is a serious genetic autoimmune disorder that affects an estimated 1 in 133 Americans, more than half of whom are still undiagnosed. The disease causes damage to the small intestine, resulting in debilitating symptoms, and if left untreated, can lead to serious long-term health problems including infertility and some types of cancer.

 

About Beyond Celiac

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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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Eli Lilly antibody trial paused over safety concerns

Checking in: The trial design calls for the data and safety monitoring board to examine results from the first 300 participants — including their need for supplemental oxygen, mechanical ventilation or other supportive care five days after receiving the treatment or a placebo — before proceeding with further enrollment.

The NIAID trial has so far enrolled 326 patients. An agency spokesperson said that the board overseeing the trial this morning “reached a predefined boundary for safety at day five.” The board will now decide whether the trial should add 700 more participants.

The NIAID spokesperson added that the pause in enrollment is “out of an abundance of caution” and the safety board is “continuing data collection and follow-up of current participants for safety and efficacy.”

The late-stage study is examining whether Lilly’s antibody, known as bamlanivimab, could help hospitalized patients. The treatment is a monoclonal antibody that mimics the antibodies the body makes naturally. It’s similar to the Regeneron antibody cocktail that President Donald Trump received recently after being diagnosed with Covid-19.

Background: Last week, Lilly asked the FDA to grant an emergency-use authorization that would allow use of the antibody treatment in high-risk patients recently diagnosed with mild-to-moderate Covid-19.

That application is largely based on preliminary data from a Phase II trial released in mid-September that showed patients who received any dose of the antibody were less likely to be hospitalized or visit the ER.

What’s next: The data and safety monitoring board overseeing the trial will review data again at a preplanned meeting on October 26. The board will recommend at that meeting whether or not enrollment should be resumed, according to NIAID.

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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

J&J says review of illness that led to pause of coronavirus vaccine trial could take days

(Reuters) – Johnson & Johnson said on Tuesday it would take a few days at least to hear from a safety monitoring panel about its review of the company’s late-stage COVID-19 vaccine trial after announcing that the large study had been paused due to an unexplained illness in one participant.

The pause comes around a month after AstraZeneca Plc also suspended trials of its experimental coronavirus vaccine – which uses a similar technology – due to a participant falling ill. That trial remains on pause.

U.S.-based J&J, whose vaccine effort is among the high profile attempts to fight the coronavirus pandemic, said on Monday the illness was being reviewed by an independent data and safety monitoring board as well as its own clinical and safety team. The data board is then required to submit its findings to the U.S. Food and Drug administration before the study can be restarted.

Mathai Mammen, head of research & development at J&J’s drugs business, said the company informed the safety board about the ill trial participant on Sunday. The board has asked for more information, he said, adding that the company is collecting information to answer its questions.

“It will be a few days at minimum for the right set of information to be gathered and evaluated,” Mammen said during a conference call to discuss the company’s quarterly results.

He said because the study is blinded, the company did not yet know if the ill person had been given the vaccine or a placebo.

J&J said such pauses are normal in big trials, which can include tens of thousands of people. The company said the trial is still on track to continue adding patients over the coming months.

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

Former FDA chief said on Twitter the trial said that the oversight of safety boards for the COVID-19 vaccine trials is evidence of the “integrity, rigor, and careful nature” of the vaccine trial process.

Experts and officials have voiced concerns that U.S. President Donald Trump could put pressure on vaccine makers to rush an unsafe or ineffective vaccine to market.

AstraZeneca last month paused late-stage trials of its experimental coronavirus vaccine developed with the University of Oxford due to a serious 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 both use modified, harmless versions of adenoviruses to deliver genetic instructions to human cells in order to spur an immune response to the target virus, in this case the novel coronavirus.

FILE PHOTO: The company logo for Johnson & Johnson is displayed to celebrate the 75th anniversary of the company’s listing at the New York Stock Exchange (NYSE) in New York, U.S., September 17, 2019. REUTERS/Brendan McDermid/File Photo

They are both also

Johnson & Johnson moves to buoy investors over paused Covid vaccine trial

US pharmaceutical giant Johnson & Johnson sought Tuesday to reassure investors after its stock slumped on an announcement that it was pausing a Covid-19 vaccine trial over a sick participant.

The company is one of several working on a vaccine, but on Monday it announced the unexplained illness, closing enrollment for the 60,000-patient trial while an independent patient safety committee is convened.

The announcement sent shares tumbling 2.3 percent at the close of trading Tuesday, even as the company reported healthy third-quarter results, with sales growing 1.7 percent to $21.08 billion.

In a conference call earlier in the day, J&J’s global research head Mathai Mammen said “our plan is to continue the study” following “a temporary pause” caused by the illness.

“It’s not at all unusual for unexpected illnesses (to occur) in large studies over their duration. In some cases, serious adverse events… may have something or nothing to do with the drug or vaccine being investigated,” he said.

The Phase 3 trial had started recruiting participants in late September, with a goal of enrolling volunteers across more than 200 US and international locations, the company and the US National Institutes for Health (NIH), which is providing funding, said.

The other countries where the trials were taking place are Argentina, Brazil, Chile, Colombia, Mexico, Peru and South Africa.

The company’s chief financial officer Joe Wolk said it was unclear whether the participant who became ill was receiving the trial vaccine or the placebo.

“We are waiting for the independent drug safety monitoring board to do their analysis,” he said.

J&J is one of 11 organizations globally to begin a Phase 3 trial on a Covid-19 vaccine.

Washington has given the multinational about $1.45 billion in funding under Operation Warp Speed.

The vaccine is based on a single dose of a cold-causing adenovirus, modified so that it can no longer replicate, combined with a part of the new coronavirus called the spike protein that it uses to invade human cells.

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As Dr. Javaid Perwaiz faces trial, the women he treated question decades of care

CHESAPEAKE, Va. — The last time Brittni DuPuy-German saw her trusted gynecologist, she once again explained that the stabbing, mystery pain in her abdomen had not gone away.

It first appeared two years earlier, after she said her doctor, Javaid Perwaiz, surgically tied her tubes. To fix it, he had proposed more surgery — three additional procedures in nine months that she said included a hysterectomy when she was 29. But the pain persisted.

So on Nov. 8, 2019, at his private-practice office, Perwaiz and DuPuy-German discussed the possibility of yet another surgery, she said. He scheduled an ultrasound for just days later, a sign of the efficiency that DuPuy-German had come to expect from her family’s longtime gynecologist. He was her mother’s doctor, her sister-in-law’s doctor, her best friend’s doctor. Perwaiz had delivered DuPuy-German and delivered her children.

Which is why, when her phone buzzed the day after her appointment, she was shocked by the headline she was reading: “Chesapeake doctor tied women’s tubes, performed hysterectomies without their consent, feds say.”

She absorbed the details of the FBI investigation. Her doctor, the news report said, was accused of lying to patients and persuading them to have life-altering surgeries they didn’t need. DuPuy-German began doubting everything Perwaiz had told her about her own body.

“That’s when all of the things that I didn’t question before started popping up,” she said.

As Perwaiz faces trial this week, a year after his arrest, DuPuy-German has received few answers to those questions — even as the FBI’s investigation expanded and the list of alleged victims grew. There are 29 patients specified in court documents and hundreds of others who contacted authorities after the doctor’s arrest.

DuPuy-German, now 32, is not cited in the criminal case but has filed a lawsuit against Perwaiz.

The U.S. attorney’s office for the Eastern District of Virginia would not say how many women in total were allegedly mistreated by Perwaiz, but in a recent trial memorandum prosecutors wrote that “the identified patients are only ‘examples’ of the scheme to defraud.”

The case, which authorities said was launched in 2018 after a hospital employee’s tip, first hinged on one charge each of health-care fraud and false statements. Federal prosecutors now allege that Perwaiz executed an “extensive scheme” spanning nearly a decade that endangered women’s pregnancies, robbed their ability to conceive and pressured them into unnecessary procedures based on unfounded cancer diagnoses and exams using broken equipment.

The more procedures Perwaiz performed, authorities said, the more money he made off insurance companies. He used the profits, according to prosecutors’ trial memorandum, “to support his lavish lifestyle.”

Perwaiz, who is jailed without bond, pleaded not guilty. He has not spoken publicly about the allegations but defense attorneys said in a court document he is “prepared to defend himself at trial.” His lawyers in the criminal case have not responded to multiple requests for comment, but have argued unsuccessfully in numerous motions to dismiss that, among other things, some charges were duplicative.

Johnson & Johnson pauses coronavirus vaccine trial following ‘unexplained illness’ in participant

Pharmaceutical giant Johnson & Johnson on Monday night announced that it had paused its late-stage COVID-19 vaccine trial after an “unexplained illness” was reported in a participant. 

“Adverse events – illnesses, accidents, etc. — even those that are serious, are an expected part of any clinical study, especially large studies,” the company said in a statement when announcing the temporary halt. 

The pause, which was first reported by the health news site STAT, come after the company began the Phase 3 trial of its vaccine in September. 

The pause, which was first reported by the health news site STAT, come after the company began the Phase 3 trial of its vaccine in September. 
(iStock)

No details on the illness were revealed, and it’s not currently clear if the illness is related to the shot or was a coincidence. It’s also not clear if the volunteer had received the vaccine or the placebo. 

“Based on our strong commitment to safety, all clinical studies conducted by the Janssen Pharmaceutical Companies of Johnson & Johnson have prespecified guidelines. These ensure our studies may be paused if an unexpected serious adverse event (SAE) that might be related to a vaccine or study drug is reported, so there can be a careful review of all of the medical information before deciding whether to restart the study,” the company added. 

CLOTH CORONAVIRUS FACE MASKS WORK — BUT ONLY IF YOU DO THIS AFTER WEARING THEM, STUDY FINDS

The pause, which was first reported by the health news site STAT, comes after the company began the Phase 3 trial of its vaccine in September. 

The temporary halt is not the first to occur in the race to find a safe and effective vaccine to protect against COVID-19. In fact, the pause is the second such hold to occur among several vaccine candidates that have reached large-scale final tests in the U.S.

RISKIEST BEHAVIORS TO AVOID DURING CORONAVIRUS PANDEMIC, ACCORDING TO AN EXPERT

Final-stage testing of a vaccine made by AstraZeneca and Oxford University remains on hold in the U.S. as officials examine whether an illness in its trial poses a safety risk. That trial was stopped when a woman developed severe neurological symptoms consistent with transverse myelitis, a rare inflammation of the spinal cord, the company has said. That company’s testing has restarted elsewhere.

Johnson & Johnson was aiming to enroll 60,000 volunteers to prove if its single-dose approach is safe and protects against the coronavirus. Other vaccine candidates in the U.S. require two shots.

CLICK FOR COMPLETE CORONAVIRUS COVERAGE 

The Associated Press contributed to this report. 

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U.S. pauses Eli Lilly’s trial of a coronavirus antibody treatment over safety concerns

  • Eli Lilly’s phase-three trial of its ACTIV-3 monoclonal antibody treatment for coronavirus has been paused due to potential safety concerns.
  • The ACTIV-3 trial is designed to test a monoclonal antibody developed by Eli Lilly in combination with remdesivir, an anti-viral with emergency use authorization for the virus.
  • It’s one of several ongoing trials, as part of the National Institute of Health’s “Activ” program, designed to accelerate the development of vaccine treatments in partnership with the pharmaceutical industry.



a group of people standing around a plane: In this May 2020 photo provided by Eli Lilly, researchers prepare mammalian cells to produce possible COVID-19 antibodies for testing in a laboratory in Indianapolis.


© Provided by CNBC
In this May 2020 photo provided by Eli Lilly, researchers prepare mammalian cells to produce possible COVID-19 antibodies for testing in a laboratory in Indianapolis.

Eli Lilly’s late-stage trial of its leading monoclonal antibody treatment for the coronavirus has been paused by U.S. health regulators over potential safety concerns, the company confirmed to CNBC on Tuesday.

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“Safety is of the utmost importance to Lilly. We are aware that, out of an abundance of caution, the ACTIV-3 independent data safety monitoring board (DSMB) has recommended a pause in enrollment,” a spokeswoman Molly McCully told CNBC. “Lilly is supportive of the decision by the independent DSMB to cautiously ensure the safety of the patients participating in this study.”

The company’s shares fell by about 3% in afternoon trading after the news started to leak out over Twitter.

The news comes less than 24 hours after Johnson & Johnson confirmed that its late-stage coronavirus vaccine trial was paused after a participant reported an “adverse event” the day before.

Dr. Mathai Mammen, global head of Janssen research and development at J&J, told investors on a conference call Tuesday that the company still has “very little information” on the reason for the holdup, including if the patient received the vaccine or the placebo. Preliminary information has been sent to the data safety monitoring board for review, he added.

Medical experts note that pauses in large clinical trials are not uncommon. They added it’s possible the bad reaction could be result of an unrelated illness, and not the drug itself. The review from the data and safety monitoring board will help determine that.

The ACTIV-3 trial is designed to test a monoclonal antibody developed by Eli Lilly in combination with Gilead Sciences’ remdesivir, an anti-viral with emergency use authorization for the virus. It’s one of several ongoing trials that are part of the National Institute of Health’s “Activ” program, which is designed to accelerate the development of Covid-19 vaccines and treatments. It is also backed by Operation Warp Speed, the Trump administration’s effort to manufacturer and distribute vaccines to fight Covid-19.

Eli Lilly’s drug is part of a class of treatments known as monoclonal antibodies, which are made to act as immune cells that scientists hope can fight the virus. The treatment was developed using a blood sample from one of the first U.S. patients who recovered from Covid-19. AstraZeneca and Regeneron, among other companies, are also working on so-called antibody treatments.

Monoclonal antibody treatments hit the headlines this month after news broke

J&J says review of illness that led to coronavirus vaccine trial pause could take days

By Carl O’Donnell and Manas Mishra

(Reuters) – Johnson & Johnson said on Tuesday it would take at least a few days for an independent safety panel to evaluate an unexplained illness of a study participant that led to a pause in the company’s COVID-19 vaccine trial.

J&J shares fell more than 2% following news of the pause and safety review. Rival AstraZeneca Plc’s U.S. trial for its coronavirus vaccine candidate – which uses a similar technology – has remained on hold for more than a month after a participant in the company’s UK trial fell ill.

J&J, whose vaccine effort is among the high profile attempts to fight the coronavirus pandemic, said on Monday the illness was being reviewed by an independent data and safety monitoring board as well as by its own clinical and safety team.

The data board, which is also reviewing AstraZeneca’s U.S. trial, is required to submit its findings to the U.S. Food and Drug Administration before the study can be restarted.

Mathai Mammen, head of research & development at J&J’s drugs business, said the company informed the safety board about the ill trial participant on Sunday. The board has asked for more information, he said, adding that the company is collecting information to answer its questions.

“It will be a few days at minimum for the right set of information to be gathered and evaluated,” Mammen said during a conference call to discuss the company’s quarterly results.

He said because the study is blinded, the company did not yet know if the ill person had been given the vaccine or a placebo. Mammen added that J&J remains on track to complete recruitment for its 60,000-person trial in the next two to three months.

EVIDENCE OF ‘INTEGRITY’

The company said such pauses are not unusual in large trials.

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

J&J has said it expects to have enough data to apply for U.S. regulatory clearance by the end of the year. Pfizer Inc and Moderna Inc have said they expect to be able to apply for FDA clearance for their vaccine candidates even sooner.

Former FDA chief Scott Gottlieb said on Twitter that the oversight of safety boards for COVID-19 vaccine trials is evidence of the “integrity, rigor, and careful nature” of the vaccine trial process.

Health experts have voiced concerns that U.S. President Donald Trump could put pressure on the FDA and drugmakers to rush an unsafe vaccine to market to bolster his re-election prospect. He has repeatedly said a vaccine could be available prior to the Nov. 3 election.

AstraZeneca last month paused late-stage trials of its experimental coronavirus vaccine developed with the University of Oxford due to a serious 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 remains on hold.