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Merck Pauses Enrollment for Two Phase 3 Clinical Trials of Investigational, Once-Monthly, Oral Islatravir for Pre-Exposure Prophylaxis of HIV-1 infection

Merck announced a pause in enrollment for the IMPOWER 22 (MK-8591-022) and IMPOWER 24 (MK-8591-024) Phase 3 clinical studies evaluating investigational, once-monthly, oral islatravir (ISL) – a nucleoside reverse transcriptase translocation inhibitor…

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Merck Announces Pause in Enrollment for Two Phase 3 Clinical Trials of Investigational, Once-Monthly, Oral Islatravir for Pre-Exposure Prophylaxis (PrEP) of HIV-1 infection

— Enrolled Participants Will Continue to Receive Study Medicine

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced a pause in enrollment for the IMPOWER 22 (MK-8591-022) and IMPOWER 24 (MK-8591-024) Phase 3 clinical studies evaluating investigational, once-monthly, oral islatravir (ISL), a nucleoside reverse transcriptase translocation inhibitor, for pre-exposure prophylaxis (PrEP) in people at high risk of HIV-1 infection.

At the recommendation of the ISL PrEP external data monitoring committee (eDMC), Merck is pausing enrollment for the IMPOWER 22 and IMPOWER 24 trials while the company conducts further analyses of these and other ongoing studies. Participants already enrolled in the trials will continue to receive the study medicine. Informed by the recommendations of the PrEP eDMC, Merck is implementing additional monitoring measures for study participants, including increasing the frequency of total lymphocyte and CD4+ T-cell assessments. Investigators have been informed of these actions.

“We continue to apply learnings from our HIV program as we move forward with the development of islatravir in both treatment and PrEP,” said Dr. Joan Butterton, vice president, infectious diseases, Global Clinical Development, Merck Research Laboratories. “Merck remains committed to developing tools to help address unmet needs in HIV treatment and prevention to contribute to the global effort against the ongoing HIV epidemic.”

About IMPOWER 22 (MK-8591-022) and IMPOWER 24 (MK-8591-024)

The IMPOWER 22 clinical trial is a Phase 3, randomized, active-controlled, double-blind clinical study to evaluate the efficacy and safety of oral islatravir once-monthly compared to once-daily emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) as pre-exposure prophylaxis (PrEP) in cisgender women at high risk for HIV-1 Infection.

The IMPOWER 24 clinical trial is a Phase 3, randomized, active-controlled, double-blind clinical study to evaluate the efficacy and safety of oral islatravir once-monthly as PrEP compared to once-daily FTC/TDF or emtricitabine/tenofovir alafenamide (FTC/TAF) in cisgender men and transgender women who have sex with men, and are at high risk for HIV-1 infection.

About Islatravir (MK-8591)

Islatravir (MK-8591) is Merck’s investigational nucleoside reverse transcriptase translocation inhibitor under evaluation for the treatment and prevention of HIV-1.

Our Commitment to HIV

For more than 35 years, Merck has been committed to scientific research and discovery (R&D) in HIV. Today, we are developing a series of antiviral options designed to help people manage HIV and protect people from HIV, with the goal of reducing the growing burden of infection worldwide. We remain committed to working hand-in-hand with our partners in the global HIV community to address the complex challenges that impede progress toward ending the epidemic.

About Merck

For over 130 years, Merck, known as MSD outside the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases in pursuit of our mission to save and improve lives. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to prevent and treat diseases that threaten people and animals – including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases – as we aspire to be the premier research-intensive biopharmaceutical company in the world. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA

This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s 2020 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

Contacts

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(215) 407-3536

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Investor Contacts:

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(908) 740-1037

Raychel Kruper
(908) 740-2107

Business Wire source:

https://www.businesswire.com/news/home/20211206005824/en

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Type-I interferon stops immune system ‘going rogue’ during viral infections

Hamilton, ON (May 17, 2022) – McMaster University researchers have found not only how some viral infections cause severe tissue damage, but also how…

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Hamilton, ON (May 17, 2022) – McMaster University researchers have found not only how some viral infections cause severe tissue damage, but also how to reduce that damage.

Credit: Georgia Kirkos/McMaster University

Hamilton, ON (May 17, 2022) – McMaster University researchers have found not only how some viral infections cause severe tissue damage, but also how to reduce that damage.

 

They have discovered how Type I interferon (IFN) stops the immune system ‘going rogue’ and attacking the body’s own tissues when fighting viral infections, including COVID-19.

 

Their paper was published in the journal PLOS Pathogens today.

  

Senior author Ali Ashkar said IFN is a well-known anti-viral signalling molecule released by the body’s cells that can trigger a powerful immune response against harmful viruses.

 

“What we have found is that it is also critical to stop white blood cells from releasing protease enzymes, which can damage organ tissue. It has this unique dual function to kick start an immune response against a viral infection on the one hand, as well as restrain that same response to prevent significant bystander tissue damage on the other,” he said.

 

The research team investigated IFN’s ability to regulate a potentially dangerous immune response by testing it on both flu and the HSV-2 virus, a highly prevalent sexually transmitted pathogen, using mice. Data from COVID-19 patients in Germany, including post-mortem lung samples, was also used in the study.

 

“For many viral infections, it is not actually the virus that causes most of the tissue damage, it is our heightened immune activation towards the virus,” said Ashkar, a professor of medicine at McMaster.

  

First co-author of the study and PhD student Emily Feng said: “Our body’s immune response is trying to fight off the virus infection, but there’s a risk of damaging innocent healthy tissue in the process. IFNs regulates the immune response to only target tissues that are infected.

 

“By discovering the mechanisms the immune system uses that can inadvertently cause tissue damage, we can intervene during infection to prevent this damage and not necessarily have to wait until vaccines are developed to develop life-saving treatments,” she added.

 

“This applies not just to COVID-19, but also other highly infectious viruses such as flu and Ebola, which can cause tremendous and often life-threatening damage to the body’s organs,” said first study co-author Amanda Lee, a family medicine resident. 

 

Ashkar said the release of harmful proteases is the result of a ‘cytokine storm’, which is life-threatening inflammation sometimes triggered by viral infections. It has been a common cause of death in patients with COVID-19, but treatment has been developed to prevent and suppress the cytokine storm.

 

Ashkar said that steroids like dexamethasone are already used to rein in an extreme immune response to viral infections. The authors used doxycycline in their study, an antibiotic used for bacterial infections and as an anti-inflammatory agent, inhibits the function of proteases causing the bystander tissue damage.

 

Lee added: “This has the potential in the future to be used to alleviate virus-induced life-threatening inflammation and warrants further research.” 

 

The study was funded by the Canadian Institutes of Health Research.

 

-30-

 

Editors:

Pictures of Ali Ashkar and Emily Feng may be found at https://bit.ly/3wmSw0D

  

 

 


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mRNA vaccines like Pfizer and Moderna fare better against COVID-19 variants of concern

A comparison of four COVID-19 vaccinations shows that messenger RNA (mRNA) vaccines — Pfizer-BioNTech and Moderna — perform better against the World…

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A comparison of four COVID-19 vaccinations shows that messenger RNA (mRNA) vaccines — Pfizer-BioNTech and Moderna — perform better against the World Health Organization’s variants of concern (VOCs) than viral vector vaccines — AstraZeneca and J&J/Janssen. Although they all effectively prevent severe disease by VOCs, the research, publishing May 17th in the open access journal PLOS Medicine, suggests that people receiving a viral vector vaccine are more vulnerable to infection by new variants.

Credit: Carlos Reusser Monsalvez, Flickr (CC0, https://creativecommons.org/publicdomain/zero/1.0/)

A comparison of four COVID-19 vaccinations shows that messenger RNA (mRNA) vaccines — Pfizer-BioNTech and Moderna — perform better against the World Health Organization’s variants of concern (VOCs) than viral vector vaccines — AstraZeneca and J&J/Janssen. Although they all effectively prevent severe disease by VOCs, the research, publishing May 17th in the open access journal PLOS Medicine, suggests that people receiving a viral vector vaccine are more vulnerable to infection by new variants.

By March 2022, COVID-19 had caused over 450 million confirmed infections and six million reported deaths. The first vaccines approved in the US and Europe that protect against serious infection are Pfizer-BioNTech and Moderna, which deliver genetic code, known as mRNA, to the bodies’ cells, whereas Oxford/AstraZeneca and J&J/Janssen are viral vector vaccines that use a modified version of a different virus — a vector — to deliver instructions to our cells. Three vaccines are delivered as two separate injections a few weeks apart, and J&J/Janssen as a single dose.

Marit J. van Gils at the University of Amsterdam, Netherlands, and colleagues, took blood samples from 165 healthcare workers, three and four weeks after first and second vaccination respectively, and for J&J/Janssen at four to five and eight weeks after vaccination. Samples were collected before, and four weeks after a Pfizer-BioNTech booster.

Four weeks after the initial two doses, antibody responses to the original SARS-CoV-2 viral strain were highest in recipients of Moderna, followed closely by Pfizer-BioNTech, and were substantially lower in those who received viral vector vaccines. Tested against the VOCs – Alpha, Beta, Gamma, Delta and Omicron – neutralizing antibodies were higher in the mRNA vaccine recipients compared to those who had viral vector vaccines. The ability to neutralize VOCs was reduced in all vaccine groups, with the greatest reduction against Omicron. The Pfizer-BioNTech booster increased antibody responses in all groups with substantial improvement against VOCs, including Omicron.

The researchers caution that their AstraZeneca group was significantly older, because of safety concerns for the vaccine in younger age groups. As immune responses tend to weaken with age, this could affect the results. This group was also smaller because the Dutch government halted use for a period.

van Gils concludes, “Four COVID-19 vaccines induce substantially different antibody responses.”

#####

In your coverage, please use this URL to provide access to the freely available paper in PLOS Medicine:

http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1003991

Citation: van Gils MJ, Lavell A, van der Straten K, Appelman B, Bontjer I, Poniman M, et al. (2022) Antibody responses against SARS-CoV-2 variants induced by four different SARS-CoV-2 vaccines in health care workers in the Netherlands: A prospective cohort study. PLoS Med 19(5): e1003991. https://doi.org/10.1371/journal.pmed.1003991

 

Author Countries: The Netherlands, United States

 

Funding: This work was supported by the Netherlands Organization for Scientific Research (NWO) ZonMw (Vici grant no. 91818627 to R.W.S., S3 study, grant agreement no. 10430022010023 to M.K.B.; RECoVERED, grant agreement no. 10150062010002 to M.D.d.J.), by the Bill & Melinda Gates Foundation (grant no. INV002022 and INV008818 to R.W.S. and INV-024617 to M.J.v.G.), by Amsterdam UMC through the AMC Fellowship (to M.J.v.G.) and the Corona Research Fund (to M.K.B.), and by the European Union’s Horizon 2020 program (RECoVER, grant no. 101003589 to M.D.d.J). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.


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Pfizer Jab In Young People Only 20% Effective After 60 Days, 0% After 5 Months

Pfizer Jab In Young People Only 20% Effective After 60 Days, 0% After 5 Months

Authored by Zachary Stieber via The Epoch Times,

The Pfizer…

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Pfizer Jab In Young People Only 20% Effective After 60 Days, 0% After 5 Months

Authored by Zachary Stieber via The Epoch Times,

The Pfizer COVID-19 vaccine turned negatively effective after five months, according to a new study.

A health care worker fills a syringe with Pfizer's COVID-19 vaccine in a file image. (Robyn Beck/AFP via Getty Images)

Researchers with the U.S. Centers for Disease Control and Prevention (CDC) analyzed test results from sites across the United States and determined that the vaccine was 60 percent effective two to four weeks after 12- to 15-year-olds got the second of the two-dose primary regimen.

But the effectiveness, measured against symptomatic illness, quickly plummeted, hitting 20 percent around month two and zero around month five.

After that, recipients in the age group were more likely to be infected by COVID-19.

Vaccine effectiveness “was no longer significantly different from 0 during month 3 after the second dose,” the researchers wrote in the study, which was published by the Journal of the American Medical Association.

Pfizer, its partner BioNTech, and the CDC didn’t respond to requests for comment.

The analyzed tests were performed between Dec. 26, 2021, and Feb. 21, 2022. Some 47,700 tests among 12- to 15-year-olds were included, with about half being unvaccinated. The testing data was on the Increasing Community Access to Testing, a program funded by the U.S. Department of Health and Human Services that contracts with pharmacy chains to perform drive-through testing. The testing data was supplemented by information in questionnaires filled out by adults with the adolescents.

Limitations of the study included vaccination being self-reported.

The study was funded by the U.S. government.

The study also found that vaccine effectiveness against symptomatic infection plunged quickly for those 5 to 11 years old, starting at 60 percent but hitting 23 percent just one month later.

One way to combat the negative effectiveness, researchers said, was to get a booster dose.

Of the 906 12- to 15-year-olds who got a third, or booster, dose, the effectiveness was measured at 71 percent two to six weeks after receipt.

Other studies, though, show that the protection from a booster, like that from the primary regimen, quickly wanes.

“Given the well-established pattern of waning mRNA VE after 2 doses and early evidence of waning of booster dose protection in adults, monitoring the duration of protection from booster doses in adolescents will be important,” researchers said.

Both the Pfizer and Moderna vaccines are built on messenger RNA (mRNA) technology. VE refers to vaccine effectiveness.

In another study published by the same journal on May 13, New York researchers reported the gap of infection and hospitalization risk between unvaccinated and vaccinated youth narrowing over time, with vaccinated 5- to 11-year-olds being infected at a rate of 62 per 100,000 and unvaccinated being infected at a rate of 70 per 100,000.

That was an incidence rate ratio of 1.1; the rate ratio for 12- to 17-year-olds was 2.

The protection also waned considerably against hospitalization over time, researchers found.

They said that the findings support “efforts to increase vaccination coverage in children and adolescents.

Tyler Durden Tue, 05/17/2022 - 13:36

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