CategoryTreatment

Pfizer begins study of oral drug for prevention of COVID-19

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Pfizer Inc said on Monday it has started a large study testing its investigational oral antiviral drug for the prevention of COVID-19 infection among those who have been exposed to the virus.

The drugmaker and its rivals, including U.S.-based Merck & Co Inc and Swiss pharmaceutical Roche Holding AG, have been racing to develop an easy-to-administer antiviral pill for COVID-19.

The mid-to-late-stage study will test Pfizer’s drug, PF-07321332, in up to 2,660 healthy adult participants aged 18 and older who live in the same household as an individual with a confirmed symptomatic COVID-19 infection.

To date, Gilead Sciences Inc’s intravenous drug remdesivir is the only approved antiviral treatment for COVID-19 in the United States.

https://www.reuters.com/business/healthcare-pharmaceuticals/pfizer-begins-study-covid-19-antiviral-drug-2021-09-27/

A daily pill to treat Covid could be just months away, scientists say

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At least three promising antivirals that could prevent symptoms and limit transmission of Covid-19 are in clinical trials.

Within a day of testing positive for Covid-19 in June, Miranda Kelly was sick enough to be scared. At 44, with diabetes and high blood pressure, Kelly, a certified nursing assistant, was having trouble breathing, symptoms serious enough to send her to the emergency room.

When her husband, Joe, 46, fell ill with the virus, too, she really got worried, especially about their five teenagers at home: “I thought: ‘I hope to God we don’t wind up on ventilators. We have children. Who’s going to raise these kids?’”

But the Kellys, who live in Seattle, had agreed just after their diagnoses to join a clinical trial at the nearby Fred Hutchinson Cancer Research Center that’s part of an international effort to test an antiviral treatment that could halt Covid early in its course.

By the next day, the couple were taking four pills, twice a day. Although they weren’t told whether they had received an active medication or a placebo, within a week, they said, their symptoms were better. Within two weeks, they had recovered.

“I don’t know if we got the treatment, but I kind of feel like we did,” Miranda Kelly said. “To have all these underlying conditions, I felt like the recovery was very quick.”

The Kellys have a role in developing what could be the world’s next chance to thwart Covid: a short-term regimen of daily pills that can fight the virus early after diagnosis and conceivably prevent symptoms from developing after exposure.

“Oral antivirals have the potential to not only curtail the duration of one’s Covid-19 syndrome, but also have the potential to limit transmission to people in your household if you are sick,” said Timothy Sheahan, a virologist at the University of North Carolina-Chapel Hill who has helped pioneer the therapies.

Antivirals are already essential treatments for other viral infections, including hepatitis C and HIV. One of the best known is Tamiflu, the widely prescribed pill that can shorten the duration of influenza and reduce the risk of hospitalization if it is given quickly.

https://www.nbcnews.com/health/health-news/daily-pill-treat-covid-could-be-just-months-away-scientists-n1279938

Ronapreve: ‘Most vulnerable’ to get new Covid drug next week

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The UK’s “most vulnerable” hospital patients, who are unable to build up an antibody response to Covid, will be offered new drug Ronapreve from Monday.

The new Covid treatment, approved just last month, uses a pair of laboratory-made antibodies to attack the virus.

It was famously used as part of the suite of experimental medicines given to US President Donald Trump last year.

The antibody cocktail has been shown to reduce hospital stays by four days and cut the risk of death by a fifth.

The government said it had secured sufficient supply of the new therapeutic for eligible NHS patients across the four nations to cover the forthcoming winter.

Health Secretary Sajid Javid said he was “thrilled it will be saving lives from as early as next week”.

“The UK is leading the world in identifying and rolling out life-saving medicines, particularly for Covid 19, and we will continue our vital work to find the best treatments available to save lives and protect the NHS,” he said.

https://www.bbc.co.uk/news/health-58602999

Very promising data from a trial with an anti-inflammatory drug called Baricitinib in Covid19 – 38% decrease in mortality

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https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(21)00331-3/fulltext

COVID-19 treatment pill administered in new Pfizer clinical trial

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US pharmaceutical giant Pfizer has started giving people doses of a pill against COVID-19 as part of a new clinical trial.

The company’s oral antiviral treatment has entered a mid-to-late-stage trial and is being tested on adults with COVID-19 symptoms who have not been treated in hospital and are not at risk of becoming severely ill.

Pfizer is one of several drug manufacturers hoping to develop the first antiviral pill to be taken for early signs of the illness.

If the trial is successful, Pfizer said it would file for emergency approval between October and December this year.

The drug manufacturer said it could be prescribed at the first sign of infection, without requiring hospitalisation.

https://news.sky.com/story/covid-19-treatment-pill-administered-in-new-pfizer-clinical-trial-12396759

Further patients benefit from drug against Long COVID

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After the Department of Ohthalmology at Universitätsklinikum Erlangen announced their global breakthrough in early July 2021 of successfully treating a Long COVID patient (aged 59), two further patients are now on the road to recovery thanks to the drug BC 007. The team at the Department of Ophthalmology has used the approach to treat two more patients. A 51 year old man from the Allgäu region and a 39 year old woman from Middle Franconia both received the active ingredient BC 007 intravenously in an infusion lasting 75 minutes, and were then kept in the hospital for monitoring for a further three days. They have continued to attend outpatient appointments to monitor their health ever since. Both patients have already reported significant improvements in their performance and quality of life, and this has been corroborated in medical tests.

Following the pattern seen in the patient who was treated first, BC 007 also caused Long COVID symptoms in these patients to subside shortly after it was administered. ‘After someone contracts COVID-19, special autoantibodies start to circulate in their bloodstream. These then turn on the body itself and may damage certain structures within the body or affect circulation,’ explains ophthalmologist PD Dr. Dr. Bettina Hohberger. The drug BC 007 was developed several years ago, originally for patients with severe heart disease, but could now potentially be used in the fight against Long COVID. ‘In both patients currently being treated, we can see that BC 007 neutralises the harmful autoantibodies and retinal micro circulation, in other words blood flow in the smallest blood vessels in the eye, improves. We can prove that this is the case using optical coherence tomography angiography, or OCT-A for short. In addition, both patients experienced a reduction in their clinical Long COVID symptoms,’ confirmed Bettina Hohberger.

https://www.research-in-germany.org/news/2021/8/2021-08-30_Further_patients_benefit_from_drug_against_Long_COVID.html

Starpharma’s Nasal Spray Reduces SARS-CoV-2 by Over 99.9% in Animal Studies

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A new antiviral nasal spray by Melbourne biotechnology firm Starpharma reportedly shows effectiveness against SARS-CoV-2 infection following a successful animal trial.

Starpharma’s Viraleze is said to have reduced the viral load by over 99.9% when it was administered nasally into the trachea and lungs of animals who were positive with the virus, compared to saline control. The results, published in the journal Viruses, provided empirical proof that SL7013 (Viraleze) was potent against the Delta variant and multiple other variations of the SARS-CoV-2.

The latest results were from research conducted by The Scripps Research Institute, which used a humanized SARS-CoV-2 mouse model under the World Health Organization’s recommendation.

The protective effects of the drug were found to be consistent with SPL7013’s virucidal activity previously reported in a separate study also by Starpharma, which highlighted the topical drug astodrimer sodium as a potential agent against the virus after one minute of exposure.

“In this study Viraleze was highly protective against SARS-CoV-2 challenge in an established SARS-CoV-2 animal model of coronavirus infection. These results provide compelling data supporting the utility of a broad-spectrum nasal spray, like Viraleze, to potentially reduce exposure to SARS-CoV-2 virus in respiratory tract and other organs. One of the potential advantages of Viraleze is its ability to significantly reduce viral load in the respiratory tract, which could lower both the transmissibility of the virus to others and severity of disease,” said Dr. Jackie Fairley, chief executive officer of Starpharma, in a statement.

The title of the report is “Medical Interventions for Treatment and Prevention of SARS-CoV-2 Infections.

https://www.biospace.com/article/nasal-antiviral-spray-shows-promising-results-against-sars-cov-2/

Israel claims new treatments could be a ‘game-changer’

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While most of the world is focused on getting as many people vaccinated as quickly as possible as new Covid-19 variants wreak havoc, such as the Delta strain has in Sydney, there is a renewed focus on developing effective treatments overseas.

And now there is burgeoning hope that “game changing” medication is on the way.

Because many health experts are coming to realise that while vaccination is the most important way to protect people from the coronavirus, it’s not the only way we can fight back.

There’s also still a huge number of unvaccinated people around the world for various reasons including lack of supply or young age, and this can create a playing field for mutations.

That’s why in Israel, companies are focused on developing medications that could prove invaluable in the fight against the virus.

EXO-CD24 is an experimental “precision” medication for inhalation, developed by Professor Nadir Arber at Tel Aviv Sourasky Medical Center.

Its aim is to halt the “cytokine storm” that affects the lungs of approximately 5-7 per cent of covid-affected patients. This occurs when the immune system starts attacking healthy cells with extra cytokine cells.

“Doctors reported good responses, and this is very encouraging and supports our hope that this drug could be a game-changer,” Arber told the Times of Israel.

Allocetra by Enlivex Therapeutics – Shai Novik is the executive chairman of Enlivex Therapeutics, an immunotherapy company who is developing another treatment for Covid-19 in Israel. He says that there has been renewed interest in treatments for the coronavirus once people realised that, while hugely important, vaccines weren’t going to spell the end for the virus.

Enlivex chief scientist and medical officer Dr Dror Mevorach undertook research that paved the way for trials of Allocetra, which is given once through an IV infusion to severely ill patients and works by reprogramming malfunctioning immune cells.

“To date, we’ve treated 10 critical and 11 severe Covid-19 patients.

“The results were encouraging. We did not see any issue with safety and tolerability. Nineteen of the 21 patients were released from the hospital in 5.6 days, on average, after receiving our drug product — less time than you’d expect at this level of illness.”

The Israeli Ministry of Health has reviewed the company’s phase II trial data, and authorised a phase IIb clinic trial involving 152 patients in Israel and Europe. Half will get Allocetra, and half a placebo.

https://www.nzherald.co.nz/world/covid-19-coronavirus-delta-outbreak-israel-claims-new-treatments-could-be-a-game-changer/PEPFSPN7SXQQ27O2YZJ2LXA3AM/

Monoclonal antibodies are free and effective against covid-19

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When Mike Burton came down with a breakthrough case of covid-19 earlier this month, the infection posed a double threat to his family. At 73, the retired surgeon faced elevated risk of serious illness. His wife, Linda, has a suppressed immune system, the result of drugs she takes after two liver transplants that put her in greater danger of life-threatening illness.

The Burtons, both vaccinated, moved to separate parts of their Mt. Sterling, Ky., home, masked up and hoped for the best.

Then a friend called and insisted they ask their doctors about monoclonal antibodies – an effective, widely available covid-19 therapy that few people are receiving.

The drugs often prevent severe disease, keeping people like Mike Burton out of the hospital if taken within seven to 10 days after symptoms begin. And since last month, they can be given prophylactically to millions of people like Linda Burton who have been exposed to the coronavirus and are at high risk of serious consequences.

Monoclonal antibodies are free to patients and there have been almost no side effects. They are accessible on an outpatient basis, via a single infusion or four injections. Hospitals, urgent care centers and even private doctors are authorized to dispense them.

Mike Burton, the Kentucky surgeon, experienced a turnaround after he received his infusion of monoclonal antibodies last week. He went to bed that night still plagued by fever, chills, a bad cough, clogged sinuses and fatigue. He woke up the next morning without any of the symptoms except fatigue and a milder cough, Linda Burton said. She did not become infected.

It’s impossible to know how Burton might have fared without the drug, but his wife credits it and prayer for their protection. “I just knew I didn’t want to get sick like he got sick,” she said. “I would’ve gotten sicker and I would not have recovered as well.”

https://news.yahoo.com/monoclonal-antibodies-free-effective-against-152854132.html

AstraZeneca’s antibody therapy prevents Covid, study shows

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AstraZeneca’s new antibody therapy reduced the risk of people developing Covid-19 symptoms by 77% in a late-stage trial, putting the drugmaker on track to offer protection to those who respond poorly to vaccines.

The company said on Friday that 75% of the participants in the trial for the therapy – two types of antibodies discovered by Vanderbilt University Medical Center – had chronic conditions including some with a lower immune response to vaccinations.

Similar therapies made with a drug class called monoclonal antibodies which mimic naturally occurring immune system proteins are being developed by Regeneron, Eli Lilly and GlaxoSmithKline with partner Vir.

https://www.cnbc.com/2021/08/20/astrazenecas-antibody-therapy-prevents-covid-study-shows.html

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