EIDD-2801

[Joes Place]

FDA Clears the Way for Ridgeback Biotherapeutics to begin Human Testing of a Promising Potential Treatment for COVID-19
4/7/2020

EIDD-2801, an oral broad-spectrum antiviral proceeding into Clinical Trials

ATLANTA and MIAMI, April 6, 2020 /PRNewswire/ -- Ridgeback Biotherapeutics LP, a closely held biotechnology company, and Drug Innovations at Emory (DRIVE), LLC, a not-for-profit biotechnology company wholly owned by Emory University, today announced that the U.S. Food and Drug Administration (FDA) has approved an Investigational New Drug application by Drug Innovation Ventures at Emory (DRIVE), LLC, wholly owned by Emory University, for an orally available antiviral compound, EIDD-2801, exclusively licensed to Ridgeback Biotherapeutics, LP (Ridgeback), a closely held biotechnology company. This action by the FDA allows Ridgeback to initiate human clinical testing of EIDD-2801 in the United States.

EIDD-2801 prevents the replication of SARS-CoV-2, the virus that causes COVID-19, and has shown potent activity against SARS-CoV and MERS-CoV in animal models of infection. In addition to coronaviruses, EIDD-2801 has broad spectrum activity against a number of diseases of public health concern, including influenza, chikungunya, Ebola, and equine encephalitis (VEE and EEE). The antiviral is orally available and, in addition to COVID-19, is being developed for the treatment of seasonal and pandemic influenza under a contract awarded to Emory Institute for Drug Development by the National Institute of Allergy and Infectious Diseases (NIAID) and for Venezuelan and Eastern equine encephalitis virus (VEEV and EEEV) by the Defense Threat Reduction Agency (DTRA).

"FDA's prompt approval of our IND allows us to initiate human testing for EIDD-2801 as quickly as possible," says George Painter, Ph.D., director of the Emory Institute for Drug Development (EIDD) and CEO of DRIVE. "We are grateful to our collaborators for helping us to assemble this application quickly, and to the FDA for expediting the process. An orally available antiviral medication would be a critical weapon for fighting COVID-19."

About EIDD-2801:

EIDD-2801 is an orally bioavailable form of a highly potent ribonucleoside analog that inhibits the replication of multiple RNA viruses including SARS-CoV-2, the causative agent of COVID-19. In animal studies of two distinct coronaviruses (SARS-CoV1 and MERS), EIDD-2801 has been shown to improve pulmonary function, decrease body weight loss and reduce the amount of virus in the lung. In addition to activity against coronaviruses, EIDD-2801, in laboratory studies, has demonstrated activity against seasonal and bird influenza, respiratory syncytial virus, chikungunya virus, Ebola virus, Venezuelan equine encephalitis virus, and Eastern equine encephalitis virus. The development of EIDD-2801 has been funded in part with Federal funds from the National Institute of Allergy and Infectious Diseases (NIAID), under contract numbers HHSN272201500008C and 75N93019C00058, and from the Defense Threat Reduction Agency (DTRA), under contract numbers HDTRA1-13-C-0072 and HDTRA1-15-C-0075.

https://www.biospace.com/article/re...a-promising-potential-treatment-for-covid-19/

 

[Joes Place]

https://www.scientificamerican.com/article/three-ways-to-make-coronavirus-drugs-in-a-hurry/

 

[artradley]

Unfortunately, this is all taking place in Atlanta. Since it is opening back up today, most of the researchers will be dead within a month.

 

[Joes Place]

Even MORE promising info on EIDD-2801:

With hints that EIDD-2801 and its active metabolite, the triphosphate of EIDD-1931, might be able to fight other RNA viruses, Painter and his collaborators began testing it against Ebola, chikungunya, and influenza. It knocked them all out. For example, just three doses of EIDD-2801 could save ferrets (animals commonly used to study human respiratory viruses) infected with influenza from the 2009 H1N1 pandemic.


The success prompted the Emory team to reach out to researchers at Vanderbilt University and the University of North Carolina at Chapel Hill in 2015 to see if their compounds, EIDD-1931 and EIDD-2801, could fight coronaviruses. Mark Denison, who leads the Vanderbilt team studying coronaviruses and how drugs can shut them down, says his group was shocked to see that EIDD-1931 was as effective as remdesivir at fighting SARS-CoV, the coronavirus that causes severe acute respiratory syndrome, and MERS-CoV, the coronavirus that causes Middle East respiratory syndrome.

“We aren’t interested in moving forward with any compound unless it works against every coronavirus,” Denison says. EIDD-2801 passed that test.

In late 2019, Painter got a contract from the National Institute of Allergy and Infectious Diseases to move EIDD-2801 into Phase I clinical trials for influenza. The plan was to file an investigational new drug application and find a partner to help with the clinical work.

Just as the team was contemplating its next move, word of a virus spreading in Wuhan, China, was starting to make news. One of Painter’s collaborators, UNC coronavirus expert Ralph Baric, immediately alerted him that the new pathogen was probably a coronavirus—one that EIDD-2801 could potentially combat.

Denison says the research team knew a coronavirus outbreak was inevitable. “Every single one of our grants, every single one of our papers predicted that this event was going to happen that’s occurring right now,” he says. “The whole goal of our drug development was to plan for this.”

“We thought, ‘Oh my god, it’s a coronavirus. We should be ready,’ ” Painter recalls.

In early March, the research team tested EIDD-1931 in human cells infected with SARS-CoV-2. The compound was able to knock out the virus. It also effectively fought coronaviruses that are resistant to remdesivir.

The researchers sped up efforts to get EIDD-2801 into clinical studies for SARS-CoV-2. Painter says they wrote the investigational new drug application for EIDD-2801 in 48 h. The application also had the fastest turnaround—about 7 days—he’s ever seen from the US Food and Drug Administration.

In March, DRIVE licensed EIDD-2801 to Ridgeback Biotherapeutics for human studies. In April, the FDA and the UK Medicines and Healthcare Products Regulatory Agency cleared the way to begin Phase I human testing, which began a few weeks ago.

Juliet Morrison, a virologist at the University of California, Riverside, says the compound appears promising from its success in cell culture studies and experiments in mice with SARS-CoV and MERS-CoV. To have an impact, it will need to be given early, she says, before the virus has had time to harm the body. EIDD-2801 “would probably not be useful for the later stages of the disease but would be useful for disease prevention potentially,” she says.​

https://cen.acs.org/pharmaceuticals...g-antiviral-takes-aim-COVID-19/98/web/2020/05

Yet, not a whisper of information from the WH or push to establish more widespread trials or anything.

It this because the folks who developed this aren't Trump Campaign or RNC donors?
Very odd, that something so ready-made to combat this virus is getting zero press, anywhere.

 

[torbee]

Sounds promising. Needs a catchier name.

Not to mention Eid is an Islamic holiday, so many deplorables probably won’t take it.

 

[luvmyhawks]

I do agree that it is odd that this isn’t getting more coverage in the media. Equally as odd is that you blame that on the White House. And weren’t you here telling all of us to keep our optimism down until hydroxy cleared some clinical trials? This hasn’t even started trials here in the us yet, yet you want it pumped up through the media?

But most importantly, it needs a new name.

 

[Joes Place]

I do agree that it is odd that this isn’t getting more coverage in the media. Equally as odd is that you blame that on the White House.

Aren't they runnin' the "Task Force"?
Would this not be a "priority" for them, and to communicate that to Americans to build confidence they are pulling out all the stops here?

The silence is deafening on this particular treatment - I can literally only come up with a single, solitary reason as to why they'd ignore it: the folks behind it aren't Trump supporters and/or are actually linked to Dems.

Can you identify another rational reason? Were I part of that Task Force, I'd be putting this up front and center, and pushing resources to help facilitate its testing and approval. It'd be on the Priority List for actions. Instead of getting politically connected "volunteers" to fumble acquistion of PPE....

 

[artradley]

Sounds promising. Needs a catchier name.

Not to mention Eid is an Islamic holiday, so many deplorables probably won’t take it.

That’s not a bug; that’s a feature.

 

[shank hawk]

The immune system is perfectly suited to deal with viruses: supplementing with Vit’s A, D & C, Zinc, Selenium, etc. should be an essential part of everyone’s diet in today’s world. Failing that, HCQ has been shown to do the same thing this new wonder drug is alleged to do, and it’s been known for at least fifteen years.

Plus, it’s cheap.

And therein lies the problem, presumably.

 

[GOHOX69]

Sounds promising. Needs a catchier name.

Not to mention Eid is an Islamic holiday, so many deplorables probably won’t take it.

In due fairness, there are many EIDS in the Islamic holiday calendar. Deplorables will get multiple chances.

 

[Joes Place]

The immune system is perfectly suited to deal with viruses

No. It is not.

#Ebola.SARS1.MERS.COVID-19.MEASLES.POLIO....etc etc etc.

 

[LBoogie28]

Unfortunately, this is all taking place in Atlanta. Since it is opening back up today, most of the researchers will be dead within a month.

To post this, you must have access to public WiFi from the alley where you sleep...cause economic collapse and all.

 

[Phenomenally Frantastic]

The immune system is perfectly suited to deal with viruses

 

[Joes Place]

Yep. It works

50% reduction in hospitalization or death

Merck Pill Intended to Treat Covid-19 Succeeds in Key Study

The drug from Merck and Ridgeback Biotherapeutics cut the risk of hospitalization or death among subjects by 50% in an early look at the study’s progress.

www.wsj.com

Merck and Ridgeback’s Investigational Oral Antiviral Molnupiravir Reduced the Risk of Hospitalization or Death by Approximately 50 Percent Compared to Placebo for Patients with Mild or Moderate COVID-19 in Positive Interim Analysis of Phase 3 Study -

At the Interim Analysis, 7.3 Percent of Patients Who Received Molnupiravir Were Hospitalized Through Day 29, Compared With 14.1 Percent of Placebo-Treated Patients Who were Hospitalized or Died Merck Plans to Seek Emergency Use Authorization in the U.S. as Soon as Possible and to Submit...

www.merck.com

Identified even before the trials were completed.

 

[EvilMonkeyInTheCloset]

https://www.scientificamerican.com/article/three-ways-to-make-coronavirus-drugs-in-a-hurry/

I got another number for you........meet ED-209

 

[hexumhawk]

No. It is not.

#Ebola.SARS1.MERS.COVID-19.MEASLES.POLIO....etc etc etc.

As a species, yes it is. That is the reason we all still exist btw.

 

[runkpanole]

The immune system is perfectly suited to deal with viruses: supplementing with Vit’s A, D & C, Zinc, Selenium, etc. should be an essential part of everyone’s diet in today’s world. Failing that, HCQ has been shown to do the same thing this new wonder drug is alleged to do, and it’s been known for at least fifteen years.

Plus, it’s cheap.

And therein lies the problem, presumably.

I’ll give you this, you’ve remained consistent in your treatment regiments, doctor.

 

[Joes Place]

As a species, yes it is. That is the reason we all still exist btw.

Nope

Viruses aren't designed to wipe out species; they go extinct, too, when that happens.

 

[shank hawk]

Gonna take a wild guess and say sugar pills were not the placebo used in this study.

The incidence of any adverse event was comparable in the molnupiravir and placebo groups (35% and 40%, respectively). Similarly, the incidence of drug-related adverse events was also comparable (12% and 11%, respectively). Fewer subjects discontinued study therapy due to an adverse event in the molnupiravir group (1.3%) compared to the placebo group (3.4%).

 

[Joes Place]

Gonna take a wild guess and say sugar pills were not the placebo used in this study.

The incidence of any adverse event was comparable in the molnupiravir and placebo groups (35% and 40%, respectively). Similarly, the incidence of drug-related adverse events was also comparable (12% and 11%, respectively). Fewer subjects discontinued study therapy due to an adverse event in the molnupiravir group (1.3%) compared to the placebo group (3.4%).

FUNFACT: In patients with lots of co-morbidities, adverse events are MUCH more common, irrespective of any "treatments".

I'm sure that's completely baffling to you. But those who deal in this stuff know it.

 

[shank hawk]

Someone didn’t read the study, but then again they didn’t release a lot of the raw data so it might not matter in this case.

All subjects had at least one co-morbidity - so either the placebo group was heavily weighted with those that had a higher number of co-morbidities, or the placebo was NOT an inert substance.

Or both.

The devil’s in the details.

 

[Joes Place]

Someone didn’t read the study, but then again they didn’t release a lot of the raw data so it might not matter in this case.

All subjects had at least one co-morbidity

Yep.

Just like I told you.
BOTH groups are at-risk of adverse events when BOTH have "at least one co-morbitity".

 

[dgordo]

As a species, yes it is. That is the reason we all still exist btw.

the reasons we still exist is because of advances in medicine. Otherwise humans would still have a life expectancy of 25 years.

 

[shank hawk]

A Merck spokesperson issued a press release this morning: “We haven’t been so excited about a product this safe and effective since the rollout, ummm, the uhh, rollout of Vio.........You know what. We’ll get back to you on this.”

 

[shank hawk]

“.......initially developed by DRIVE as a broad-spectrum antiviral against equine encephalitis and influenza, but laboratory tests showed it was also active against coronaviruses.”

But. But. But..........
🤣 🤣 🤣 🤣 🤣 🤣 🤣

 

[Joes Place]

“.......initially developed by DRIVE as a broad-spectrum antiviral against equine encephalitis and influenza, but laboratory tests showed it was also active against coronaviruses.”

But. But. But..........
🤣 🤣 🤣 🤣 🤣 🤣 🤣

So, this makes you think "ivermectin" has to be effective, I'm guessing.

PROTIP: It is not.

 

[shank hawk]

According to Barron's, some scientists who have studied the drug believe that its method of suppressing the virus could potentially run amok within the body.

Some scientists who have studied the drug warn, however, that the method it uses to kill the virus that causes Covid-19 carries potential dangers that could limit the drug’s usefulness.
Molnupiravir works by incorporating itself into the genetic material of the virus, and then causing a huge number of mutations as the virus replicates, effectively killing it. In some lab tests, the drug has also shown the ability to integrate into the genetic material of mammalian cells, causing mutations as those cells replicate.
If that were to happen in the cells of a patient being treated with molnupiravir, it could theoretically lead to cancer or birth defects.

In particular, Raymond Schinazi, a professor of pediatrics and the director of biochemical pharmacology at Emory who studied the drug while it was being developed, and published a number of papers on NHC, the compound that's the active ingredient in the drug. He published a paper that showed the drug can produce a reaction like the one described above, and insisted it shouldn't be given to young people - especially pregnant women - without more data.

Schinazi told Barron’s that he did not believe that molnupiravir should be given to pregnant women, or to young people of reproductive age, until more data is available. Merck’s trials of molnupiravir have excluded pregnant women; the scientists running the trial asked male participants to “abstain from heterosexual intercourse” while taking the drug, according to the federal government website that tracks clinical trials.

Barron's even shared a paper published in the Journal of Infectious Diseases in May by Schinazi and scientists at the University of North Carolina which reported that NHC can cause mutations in animal cell cultures in a lab test designed to detect such mutations - something Merck claims it has tested for.

 

[RileyHawk]

According to Barron's, some scientists who have studied the drug believe that its method of suppressing the virus could potentially run amok within the body.


In particular, Raymond Schinazi, a professor of pediatrics and the director of biochemical pharmacology at Emory who studied the drug while it was being developed, and published a number of papers on NHC, the compound that's the active ingredient in the drug. He published a paper that showed the drug can produce a reaction like the one described above, and insisted it shouldn't be given to young people - especially pregnant women - without more data.


Barron's even shared a paper published in the Journal of Infectious Diseases in May by Schinazi and scientists at the University of North Carolina which reported that NHC can cause mutations in animal cell cultures in a lab test designed to detect such mutations - something Merck claims it has tested for.

Thus, it is being studied. Duh.

 

[Joes Place]

According to Barron's, some scientists who have studied the drug believe that its method of suppressing the virus could potentially run amok within the body.

FUNFACT: This is why they've been testing it in people FOR OVER A YEAR NOW.

 

[shank hawk]

Aspirin lowers risk of COVID: New findings support preliminary trial

The treatment reduced the risk of reaching mechanical ventilation by 44%. ICU admissions were lower by 43%, and an overall in-hospital mortality saw a 47% decrease.

m.jpost.com