GSK says tests indicate antibody drug works against Omicron


Laboratory analysis of the antibody-based COVID-19 therapy GlaxoSmithKline is developing with U.S. partner Vir has indicated the drug is effective against the new Omicron variant, the British drugmaker said on Thursday.

A GSK statement said that lab tests and a study on hamsters have demonstrated the sotrovimab antibody cocktail works against viruses that were bio-engineered to carry a number of hallmark mutations of the Omicron variant.

The two companies have been engineering so-called pseudoviruses that feature major coronavirus mutations across all suspicious variants that have emerged so far, and have run lab tests on their vulnerability to sotrovimab treatment.

An analysis of past tests has now yielded the preliminary clearance for the drug, because Omicron’ main mutations have been found across a variety of previous variants.

“We’ve been carefully following every mutation that might be important,” said Herbert Virgin, Vir’s Chief Scientific Officer.

“With this new variant, the mutations that we have tested so far have no significant effect on sotrovimab,” he added.

“Sotrovimab was deliberately designed with a mutating virus in mind,” said Vir Chief Executive George Scangos, adding that the drug was targeting a region of the spike protein that was highly unlikely to mutate.

MHRA approves Xevudy (sotrovimab), a COVID-19 treatment found to cut hospitalisation and death by 79%


Another COVID-19 treatment, Xevudy (sotrovimab), has today been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) after it was found to be safe and effective at reducing the risk of hospitalisation and death in people with mild to moderate COVID-19 infection who are at an increased risk of developing severe disease.

This follows a rigorous review of its safety, quality and effectiveness by the UK regulator and the government’s independent expert scientific advisory body, the Commission on Human Medicines, making it the second monoclonal antibody therapeutic to be approved following Ronapreve.

Developed by GSK and Vir Biotechnology, sotrovimab is a single monoclonal antibody. The drug works by binding to the spike protein on the outside of the COVID-19 virus. This in turn prevents the virus from attaching to and entering human cells, so that it cannot replicate in the body.

In a clinical trial, a single dose of the monoclonal antibody was found to reduce the risk of hospitalisation and death by 79% in high-risk adults with symptomatic COVID-19 infection.

It is too early to know whether the omicron variant has any impact on sotrovimab’s effectiveness but the MHRA will work with the company to establish this.

New Covid Drugs Are Here—and They Could Change the Pandemic


Vaccines and great, and you should get yours. But for almost two years now, alongside the showy and ultimately successful hunt for vaccines that fight Covid-19, scientists have also been looking for drugs to treat people who were already sick. That hasn’t gone quite as well: a scientific quest tangled up in hundreds of studies too small to give real answers, then sidetracked by hype over the antimalarial hydroxychloroquine and then the antiparasitic ivermectin. Those didn’t work. But the research continued—and in the past few weeks, it seems to have paid off.

First, in early October, the transnational pharmaceutical company Merck and a biotech company called Ridgeback announced that molnupiravir, a decades-old antiviral drug invented at Emory University, reduced the risk of hospitalizations and deaths in people with Covid-19 by a respectable 50 percent. Then, in early November, the equally transnational pharmaceutical company Pfizer (you might remember it from its mRNA-based Covid vaccine) announced that its purpose-built antiviral Paxlovid likewise reduced the hospital-and-death risk in high-risk Covid patients by a whopping 89 percent.

That’s a win, right? Covid vaccines are finicky, hard to manufacture, and hard to distribute because of, in the case of the ones based on mRNA, a snowflake-like need for ultracold freezers. The steroid dexamethasone is for the severely ill. Monoclonal antibodies have to be administered early to work, and, like the antiviral drug remdesivir, they’re expensive, and both require hospital visits for intravenous infusion. But molnupiravir and Paxlovid are “small-molecule” drugs, easier to make, more stable in storage and distribution, and—this is the big one—they’re just pills. You pop ’em. On a planet ravaged by a pandemic virus, with effective vaccines unavailable in most places, easy-to-use, relatively cheap drugs could help beat the disease. “They’re game-changing in the sense that they’re both pills and therefore relatively easy to take,” says Charles Gore, executive director of the Medicines Patent Pool, a UN-supported organization that sets up international licensing agreements for drugs. “You don’t have to lie down to get an infusion, or walk 150 miles to get to a hospital.”

That’s convenient. And both Merck and Pfizer have also announced extensive licensing agreements with generic drugmakers and tiered pricing for lower-income countries, which is good for places that haven’t been able to afford the vaccines that North America and Europe have been hoarding. “I think the combination of these drugs and vaccines will really make a difference,” says Jayasree Iyer, CEO of the Access to Medicine Foundation, which works on getting critical drugs into lower-income countries. Vaccine makers know they have to do the same kind of technology transfer and licensing agreements for those, Iyer says, “but that’s going to take longer, and the immediate need now has an immediate drug.”

Schaper says the company will have 3 million courses of treatment ready to deploy to low- and middle-income countries as soon as approval comes, and then international generics makers will be able to make medicine for more than 100 countries. Molnupiravir is already approved in the United Kingdom, and the US government has agreed to buy 1.4 million courses of treatment. “Pricing indications, from some academic work on the Merck drug, suggest that it could be around $20 for the five-day course, falling to $10 if they use a process that the Gates Foundation has funded, which optimized production,”

Pfizer, on the other hand, has only just started making pills, but the company also has an agreement with the Medicines Patent Pool. Its Paxlovid blocks an enzyme that the SARS-CoV-2 virus uses to cut big chunks of protein into the sizes and shapes the virus needs to reproduce itself—a “protease inhibitor” like the drugs that were instrumental in the fight against HIV and AIDS. In Paxlovid, that protease inhibitor comes with another drug, ritonavir, that keeps a person’s liver from breaking down the protease inhibitor. A Pfizer spokesperson declined to make anyone from the company available for an interview, but the press release in which Pfizer announced its early trial results also quoted CEO Albert Bourla calling the drug “a real game changer,” for what that’s worth.

According to Pfizer’s spokesperson, the company expects to be able to make 120,000 full courses of the drug before the end of the year, and 50 million courses a year after that. The license deals the company has made via the MPP guarantee tiered pricing to 95 countries—more than half the humans on Earth. And Pfizer has said generic drugmakers in low-income countries need never pay them royalties—in fact, the company won’t collect royalties from anyone until the World Health Organization says the pandemic is over.

AstraZeneca’s antibody cocktail helps prevent COVID-19 for at least 6 months


AstraZeneca on Thursday cemented its lead in bringing a preventative COVID-19 shot to market, saying its antibody cocktail offered 83% protection over six months, providing another possible weapon in the fight against the pandemic.

The therapy, called AZD7442 or Evusheld, had previously been shown to confer 77% protection against symptomatic illness after three months, in an earlier readout of the late-stage PROVENT trial in August. read more

The data give hope of additional protection for people who do not respond well to vaccines, such as cancer patients.

The Anglo-Swedish company also said a separate study in patients with mild-to-moderate COVID-19 showed a higher dose of AZD7442 cut the risk of symptoms worsening by 88% when given within three days of the first symptoms.

Pills could prove COVID game changer


Harvard experts in medical therapeutics say the recent development of pills to treat COVID-19 may turn out to be a pandemic game changer for a simple reason: When it comes to treating the ailment, the earlier the better.

Mark Namchuk, executive director of Harvard Medical School’s Therapeutics Initiative, said pills have some clear advantages over existing treatments — the drug remdesivir and a handful of antibody therapies — because they are by comparison easy to transport, store, and administer. The other treatments must be given intravenously and have largely been reserved for use by the sickest patients confined to medical facilities late in their illness’ course.

Namchuk said that assuming the pills are made widely available, they can be prescribed soon after symptoms start at home, with nothing else required to administer them beyond possibly a glass of water.

“They’re both oral, so much easier to get them distributed to folks early in their illness and make them more broadly available,” said Namchuk, professor of the practice of biological chemistry and molecular pharmacology. “The efficacy is very encouraging, but the route of administration opens up the possibility of using it more broadly.”

The assessment comes after reports by Merck and Ridgeback Biotherapeutics that their COVID-19 pill — currently being reviewed by federal regulators — lowers risk of hospitalization and death by 50 percent, and on the heels of last week’s promising results by Pfizer Inc., which said a Phase 2/3 study of its pill showed that it cuts risk of hospitalization and death by 89 percent. The Pfizer results were so promising the study was halted early, the company said. About 1 percent of study participants (6 out of 607) were hospitalized, and none died after 28 days. That compared with 6.7 percent (41 out of 612) hospitalized in the control group, with 10 subsequently dying. The company also plans to seek FDA emergency use authorization to market the pill.

Paxlovid, Pfizer’s COVID-19 oral antiviral shows the risk of hospitalisation or death is reduced by nearly 90%


Antibody drugs could protect people with weak immune systems against Covid


Even as the Covid delta wave ebbs in the U.S., millions of people with compromised immune systems remain trapped in an anxious and sequestered limbo. A considerable portion of this population, research indicates, remains highly vulnerable to the coronavirus even after three or four vaccine shots.

Many immunocompromised Americans, including people with cancer, autoimmune disorders and transplanted organs, are impatiently awaiting what could be their ticket back to some semblance of normalcy: the ability to receive periodic injections of long-acting monoclonal antibodies. This, research suggests, could provide them the substantial protection against Covid-19 that in their cases vaccination may not.

The Food and Drug Administration could soon grant emergency authorization to monoclonal antibodies from drugmaker Regeneron for what is known as pre-exposure prophylaxis, or PrEP, against Covid-19. If cleared by the FDA, Regeneron’s therapy could be given as a set of injections every one to three months before potential exposure to the coronavirus.

First pill to treat Covid gets approval in UK


The first pill designed to treat symptomatic Covid has been approved by the UK medicines regulator.

The tablet – molnupiravir – will be given twice a day to vulnerable patients recently diagnosed with the disease.

In clinical trials the pill, originally developed to treat flu, cut the risk of hospitalisation or death by about half.

Health Secretary Sajid Javid said the treatment was a “gamechanger” for the most frail and immunosuppressed.

In a statement he said: “Today is a historic day for our country, as the UK is now the first country in the world to approve an antiviral that can be taken at home for Covid.”

Common antidepressant fluvoxamine slashes risk of COVID death


A cheap, widely available drug used to treat mental illness cuts both the risk of death from COVID-19 and the need for people with the disease to receive intensive medical care, according to clinical-trial results1.

The drug, called fluvoxamine, is taken for conditions including depression and obsessive–compulsive disorder. But it is also known to dampen immune responses and temper tissue damage, and researchers credit these properties for its success in the recent trial. Among study participants who took the drug as directed and did so in the early stages of the disease, COVID-19-related deaths fell by roughly 90% and the need for intensive COVID-19-related medical care fell by roughly 65%.

“A major victory for drug repurposing!” Vikas Sukhatme at Emory University School of Medicine in Atlanta, Georgia, who studies drug repurposing, wrote in an e-mail to Nature. “Fluvoxamine treatment should be adopted for those at high risk for deterioration who are not vaccinated or cannot receive monoclonal antibodies.”

Study co-author Angela Reiersen, a psychiatrist at Washington University School of Medicine in St. Louis, Missouri, has long been interested in using fluvoxamine to treat a rare genetic condition. While monitoring the fluvoxamine literature before the pandemic, she came across a 2019 study showing that fluvoxamine reduced inflammation in mice with sepsis2. When COVID-19 hit, “I immediately thought back to that paper with the mice,” she says.

Reiersen and her colleagues partnered with the organizers of the TOGETHER Trial, which aims to identify approved drugs that can be repurposed to treat COVID-19. The team’s study included 1,497 people in Brazil who had COVID-19 and were at high risk of severe disease. Roughly half received fluvoxamine, and the rest received a placebo.

The trial’s results, published on 27 October, mean that fluvoxamine is one of a handful of therapies that show strong evidence of preventing progression from mild to severe COVID-19. The only early-stage treatments currently recommended by the US National Institutes of Health are monoclonal antibodies, which are costly and difficult to administer in an outpatient setting.

Merck Will Share Formula for its Covid Pill With Poor Countries


Merck has granted a royalty-free license for its promising Covid-19 pill to a United Nations-backed nonprofit in a deal that would allow the drug to be manufactured and sold cheaply in the poorest nations, where vaccines for the coronavirus are in devastatingly short supply.

The agreement with the Medicines Patent Pool, an organization that works to make medical treatment and technologies globally accessible, will allow companies in 105 countries, mostly in Africa and Asia, to sublicense the formulation for the antiviral pill, called molnupiravir, and begin making it.

Merck reported this month that the drug halved the rate of hospitalizations and deaths in high-risk Covid patients in a large clinical trial. Affluent nations, including the United States, have rushed to negotiate deals to buy the drug, tying up large portions of the supply even before it has been approved by regulators and raising concerns that poor countries would be shut out of access to the medicine, much as they have been for vaccines.

Treatment-access advocates welcomed the new deal, which was announced Wednesday morning, calling it an unusual step for a major Western pharmaceutical company.