SARS-CoV-2 Archives - Page 3 of 5 - Medical Design Sourcing

Roche and Atea’s COVID-19 pill disappoints in Phase 2 trial

Interest in oral antivirals has surged in recent weeks. Merck (NYSE:MRK) announced on October 1 that the investigational antiviral molnupiravir appeared to halve the risk of hospitalization from COVID-19.

Roche (SWX:ROG) and Atea (NSDQ:AVIR) are having less luck with the oral, direct-acting antiviral drug candidate AT-527.

The two companies announced that the Phase 2 MOONSONG trial failed to meet its primary endpoint related to reducing the level of SARS-CoV-2 in patients with mild-to-moderate COVID-19 relative to placebo.

The drug appeared to be more effective in high-risk patients with underlying health conditions.

Roche and Atea are mulling whether they can modify the international Phase 3 MORNINGSKY study to increase the risk of achieving a statistically significant benefit. The companies expect data from that trial in the second half of 2022.

Both companies saw their stock price decline in the aftermath of the announcement. AVIR shares…

Antivirals could be a vital weapon in the COVID-19 pandemic endgame

Transmission electron microscope image of SARS-CoV-2. Image from NIH.

Antivirals have several advantages over vaccines. They tend to be broadly effective against viral variants and offer faster-acting protection than vaccines. In addition, antivirals are usually simple to transport and don’t require ultra-cold storage. And oral antivirals would have an advantage in terms of the speed of protection they offer. For SARS-CoV-2, antivirals also could provide an alternative to vaccines in the scores of vaccine-hesitant people. Additionally, antivirals have a proven track record against other viruses like HIV and hepatitis C, where vaccines aren’t available.

“We need antivirals,” surmised Kamlendra Singh, a molecular microbiology and immunology professor at the University of Missouri (Columbia, Missouri).

“It’s not that the vaccines aren’t working. They are working wonders,” Singh said. But antivirals will likely emerge as an indispensable tool as SARS-CoV-2 continue…

Antivirals could be a vital weapon in the COVID-19 pandemic endgame

Transmission electron microscope image of SARS-CoV-2. Image from NIH.

Antivirals have several advantages over vaccines. They tend to be broadly effective against viral variants and offer faster-acting protection than vaccines. In addition, antivirals are usually simple to transport and don’t require ultra-cold storage. And oral antivirals would have an advantage in terms of the speed of protection they offer. For SARS-CoV-2, antivirals also could provide an alternative to vaccines in the scores of vaccine-hesitant people. Additionally, antivirals have a proven track record against other viruses like HIV and hepatitis C, where vaccines aren’t available.

“We need antivirals,” surmised Kamlendra Singh, a molecular microbiology and immunology professor at the University of Missouri (Columbia, Missouri).

“It’s not that the vaccines aren’t working. They are working wonders,” Singh said. But antivirals will …

Merck finds molnupiravir cuts COVID-19 hospitalization rate in half

The oral antiviral molnupiravir from Merck (NYSE:MRK) and Ridgeback Biotherapeutics fared well in a planned interim analysis of the Phase 3 MOVe-OUT trial.

If authorized by FDA, the pill would be the first oral antiviral for SARS-CoV-2 in the U.S.

To date, all authorized or approved COVID-19 drugs require subcutaneous, intramuscular or intravenous administration.

Merck intends to file an EUA for the oral therapy soon.

“With these compelling results, we are optimistic that molnupiravir can become an important medicine as part of the global effort to fight the pandemic and will add to Merck’s unique legacy of bringing forward breakthroughs in infectious diseases when they are needed most,” Merck CEO Robert M. Davis said in a statement.

The molnupiravir study focused on initially non-hospitalized adults with mild-to-moderate COVID-19. It found that 7.3% of molnupiravir recipients were hospitalized within 29 days. By contrast, 14.1% of placebo …

Pfizer launches Phase 2/3 trial of COVID-19 oral antiviral cocktail

Pfizer (NYSE:PFE) has announced the launch of the Phase 2/3 EPIC-PEP study to test its oral antiviral candidate PF-07321332 as a post-exposure prophylaxis.

The EPIC-PEP study, whose name is an acronym of “Evaluation of Protease Inhibition for COVID-19 in Post-Exposure Prophylaxis,” will test the efficacy of PF-07321332 with low-dose ritonavir to prevent COVID-19 infection.

PF-07321332 and ritonavir are both protease inhibitors. AbbVie’s Ritonavir (Norvir) initially won FDA approval as an HIV treatment in 1996.

Molecular structure of PF-07321332. Image from Wikipedia.

Trial participants must be 18 or older and live in the same household as an individual with laboratory-confirmed symptomatic SARS-CoV-2 infection.

The study will enroll up to 2,660 participants.

“Given the continued emergence and evolution of SARS-CoV-2 variants and their immense impact, we continue to work diligently…

Why the pandemic is a crucible for clinical trial innovation

Image from Sam Moqadam on Unsplash

The rapid pace of development of COVID-19 vaccines and antibodies has redefined expectations for clinical trials. As SARS-CoV-2 variants such as Delta continue to fuel the epidemic, the industry must continue to ensure testing and clinical trials stay ahead of mutations.

To get a clearer sense of what the ramifications of this accelerated development will be for the industry at large, we spoke with Neta Bendelac, senior director of strategy at 4G Clinical, which offers software and services for clinical drug trials.

Drug Discovery & Development: What impact has the pandemic had on trials for COVID-19 therapies?

Neta Bendelac: Speed was the most important factor for the early COVID-19 studies as many sponsors raced to get promising therapies and potential vaccines into the clinic. We all felt the urgency, all day, every day. It made sense for the FDA to sti…

An inside look at Pardes Biosciences’ oral coronavirus protease inhibitor

Two months after exiting stealth mode via a SPAC merger, the early-stage biopharma Pardes Biosciences (Palo Alto, California) has launched a first-in-human trial for its investigational COVID-19 pill PBI-0451.

The origins of the company stretch back to the early days of the pandemic, said Dr. Uri Lopatin, CEO and co-founder of the company.

A visiting partner at the startup accelerator Y Combinator, Lopatin discussed the novel coronavirus with Lee Arnold, a Ph.D. chemist and former chief scientific officer of Assembly Biosciences, which Lopatin had also co-founded.

Lee remarked that the novel coronavirus bore a resemblance to SARS and MERS.

In particular, the SARS-CoV-2 main protease resembled those from other beta coronaviruses, which is one of four groupings of such spike-crowned viruses.

Standing on the shoulders of giants

Lee recalled that scientists had worked diligently on protease inhibitors targeting SARS and MERS. That work was now …

Study finds Moderna’s COVID-19 vaccine drives a stronger antibody response than Pfizer’s

Research published in JAMA found the Moderna’s COVID-19 vaccine drove an antibody response that was more than two times greater than that of Pfizer’s.

Specifically, the Moderna mRNA-1273 vaccine generated post-second-dose antibody levels of 2,881 units per milliliter. Those who received the Pfizer-BioNTech BNT162b2 vaccine had antibody levels measuring 1,108 units per milliliter.

The study involved 1,647 fully vaccinated healthcare workers in Belgium.

Immune protection, however, involves more than antibody levels. Pfizer researchers found that recipients of their vaccine have immune protection 12 days after vaccination when there are low antibody levels, according to a STAT article.

In volunteers who had previously contracted COVID-19, the Moderna vaccine recipients generated antibody levels of 3,836 units per milliliter, while antibody levels in Pfizer-BioNTech vaccine recipients were 1,444 units per milliliter.

Some 688 volunt…

Mutated COVID-19 variant C.1.2 elicits concern

[Photo by Fusion Medical Animation on Unsplash]

As even countries with substantial vaccination rates such as the U.S., U.K. and Israel continue to fight the Delta variant, a new threat appears to have emerged in South Africa.

First spotted in South Africa, the C.1.2 variant is potentially more infectious and resistant to antibodies than Delta. Scientists continue to study the variant’s potential to infect the vaccinated and unvaccinated.

Scientists first spotted C.1.2 in Mpumalanga and Gauteng, two provinces in Eastern South Africa.

Outside of South Africa, researchers have identified the variant in other African nations, New Zealand, the U.K. and mainland Europe.

Also troubling is that the C.1.2 variant is mutating at a rate of 41.8 mutations annually — 1.7 times the rate of other variants of concern, according to a preprint study published in MedRxiv.

Another MedRxiv prepri…

Pardes Biosciences launches first-in-human trial for SARS-CoV-2 antiviral

A handful of companies may have a lock on COVID-19 vaccines, but competition is heating up in antivirals targeting the novel coronavirus.

One of the latest entrants is Pardes Biosciences (Carlsbad, Calif.), which recently announced a Phase 1 trial for PBI-0451, an oral antiviral targeting SARS-CoV-2.

Other companies developing antivirals for COVID-19 include Pfizer as well as Merck and its partner Ridgeback Biotherapeutics. In addition, Gilead Sciences scored the first FDA approval for COVID-19 with its broad-spectrum IV-based antiviral Remdesivir, which it first envisioned as an Ebola treatment.

PBI-0451 inhibits viral main protease (Mpro).

Researchers have validated viral proteases over the years for viruses such as hepatitis C and human immunodeficiency virus.

Given their mode of action, oral antivirals could also be effective against variants of concern.

Mpro is common across SARS-CoV-2 variants as well as multiple other coronavi…

How Delta could change the COVID-19 landscape

[Image courtesy of CDC]

Delta is “an extremely transmissible variant and has taken us all for a loop,” said Dr. Monica Gandhi, a professor of medicine and associate division chief of the division of HIV, infectious diseases and global medicine at University of California, San Francisco.

But despite Delta’s hurricane-like ascent, the volume of infections it drives are likely to fall just as quickly after peaking, Gandhi said in a webinar from the Bay Area Council.

Delta could peak anywhere from mid-August to mid-October, according to several experts quoted in WebMD.

In the interim, Delta will remain most threatening for the unvaccinated and those without prior COVID-19 infections, although the variant will likely continue to drive breakthrough infections in vaccinated individuals.

In highly vaccinated areas of the U.S. where the vaccine has spread, there has been a “decou…

REGEN-COV lowers risk of symptomatic COVID-19 infections by 81% in study

Regeneron’s (NSDQ:REGN) REGEN-COV remains one of the most effective monoclonal antibody therapies in reducing the risk of serious COVID-19 infections and resulting hospitalizations and deaths. A study recently published in the New England Journal of Medicine found that the drug effectively prevented COVID-19 disease in household contacts of individuals infected with the novel coronavirus.

When delivered subcutaneously, REGEN-COV was 81.4% effective at reducing the risk of symptomatic infections and led to a 92.6% reduction of symptomatic infections after the first week.

Consisting of the monoclonal antibodies casirivimab and imdevimab, REGEN-COV also appeared to accelerate the recovery of COVID-19-infected individuals. In recipients who received the drug, symptoms resolved two weeks faster than in placebo recipients.

Study investigators also found that the drug was generally well-tolerated.

“This peer-reviewed NEJM publication demonstrates that RE…