8/12/2020 Dr. Yogendra Show Guest Dr. Jonathan Javitt -Subject RLF-100 COVID 19
8/12/2020 Dr. Yogendra Show Guest Dr. Jonathan Javitt -Subject RLF-100 COVID 19: Video automatically transcribed by Sonix
8/12/2020 Dr. Yogendra Show Guest Dr. Jonathan Javitt -Subject RLF-100 COVID 19: this mp4 video file was automatically transcribed by Sonix with the best speech-to-text algorithms. This transcript may contain errors.
Introduction
Dr Yogendra:
Hi, this is Dr. Yo from the doctor Yo show today I have a very special guest with me, very distinguished guest, Dr. Jonathan Javitt. Dr. Javitt played leadership roles in seven successful healthcare I.T. and biopharma startups. He's been led drug development engagements for Merck, Allegan, Pharmacia, Novartis and Pfizer. He was appointed to health care leadership roles under Presidents Reagan, George H.W. Bush, Clinton and George W. Bush.
Dr Yogendra:
He's a graduate of Princeton University, Cornell University Medical College, Harvard School of Public Health, Willis Eye Hospital and Johns Hopkins Medical School. Dr. Javitt has published more than two hundred scientific works in the areas of health outcomes and formal economics that have been cited by more than sixteen thousand people. Dr. Javitt, thank you very much for joining me today. Just just wonderful.
Dr Yogendra:
I know you're so busy, but we've been talking a little bit about on social media and in the news about RLF one hundred and some of the new exciting news regarding the clinical trial. So I'm just going to turn the platform over to you. And if you could just sort of kind of give us some background and tell us something more about the studies.
Dr Javitt:
Well, thank you so much for inviting me, and Dr. Javid is my 90 year old dad who's still writing more scientific papers than I am just John. And tell me what I can tell you. What do your readers want to know?
(VIP )Vasoactive Intestinal Peptide background Clinical Trial Background on RLF-100
Dr Yogendra:
So so here as you know there is Well, one thing is the the RLF one hundred. If you can just sort of give us a background into what the Vaso active intestinal peptide VIP is, sort of how did I guess what was your interest in sort of tying that with covid-19? Obviously you guys had done some research into Airds before. And if you can also talk a little bit about the the study, I think of us in Houston, I think you're looking at the six patients, just sort of the sum of the outcomes and some of the positive results that you were able to report.
Dr Javitt:
Sure, and the study is still ongoing, so Houston Methodist Hospital is one of our lead study sites and they're continuing to enroll patients both in a randomized trial, which means we don't know who's getting drug and who's getting placebo.
OPEN LABEL EAP Clinical Trial
Dr Javitt:
And also in a what the FDA calls an expanded access trial, a trial for people who are too sick to get into the randomized trial, people with lung transplants, kidney transplants, cancer or heart attacks. And they're being treated open label.
Dr Javitt:
So the data you're hearing about are coming from that open label study because, of course, the the main FDA trial is still blinded.
Explanation of How Vasoactive Peptide works to fight COVID-19
Dr Javitt:
So VIP has been around as long as humans have been around. In fact, it's been around as long as mammals have been around. And it's the primary peptide and the peptide is just a short protein that protects the epithelial cells in the lung. That is the cells that line the lung. And people kind of take lungs for granted, air goes in or goes out. Some people understand that the air that comes in the oxygen and it goes across the lung into the blood.
Dr Javitt:
But nobody thinks too much about how that can happen because after all, air doesn't go across your skin doesn't go across the other parts of your body, but it goes across your lungs and as it happens. I brought you a picture of maybe that'll help a little bit. Here you go. OK,
Slide With VIP Explanation
Dr Javitt:
So the reason that's able to happen is the thin tissues in the lung, the little RSX called alveoli are lined with this fluid called surfactant. It's almost like this. So it's like a little bubble that keeps the lung tissue moist and open. And because of that, the oxygen from the blood is able to from the air, is able to go across into the blood and the carbon dioxide from the blood is able to go out through the lung.
Dr Javitt:
Well, if the surfactant fails and the lungs dry out, they collapse and you don't transmit oxygen. And that's exactly what happens in covid-19. So the vast majority of people who get hit by this virus don't even know it.
Dr Javitt:
Less than one in 10 people who gets infected by the coronavirus actually gets covid-19. Some may think they have a touch of a cold for days. Some may not know anything. But the ones that do get this disease, this lethal disease, because the spike from the virus binds to that alveolar type two cell. So it's a little bit like hitting a needle in a haystack because most of the cells in the lung just mind their own business and the coronavirus doesn't attack them.
Dr Javitt:
But unfortunately, it does attack these rare type two cells because the spike on the virus finds a receptor on the type two cells, kind of like a key hitting a lock. The problem is those type two cells are the ones that make all the surfactant, so if you knock out those cells, the lung is not transmitting any oxygen.
Dr Javitt:
And now you're one of those what doctors sometimes call happy hypoxic. The people who come in with covid, who don't look sick, they don't have a big fever. They don't look like they have the flu, but they can't walk across the room without falling down. There's no oxygen.
Dr Javitt:
Well, unfortunately, once the virus gets going, it does much worse than just knock down the oxygen, it makes millions of copies of itself. It's called viral replication, which use big words when you small words would do better, but it makes millions of copies of itself inside the lung cell.
Cytokines explained rudimentarily
Dr Javitt:
And ultimately it bursts that cell wide open and lets loose a swarm of inflammatory cytokines and other things that put you in the ICU, put you on a ventilator and kill you pretty quickly. So it's a pretty lethal infection, as we all know.
Dr Javitt:
Well, it turns out that VIP VasoActive intestinal peptide, which is the terrible name for it, it's just that Dr. Sami Said discovered it in the intestine. So he named it from where he discovered it, even though 70 percent of the VIP in the body is in the lung.
Specific Receptors
Dr Javitt:
Turns out the VIP also has a specific receptor on the type two cells of the lung. And when it binds to that receptor, it goes inside the cells and it stops the virus from replicate and actually stops the coronavirus in its tracks inside the cell.
Dr Javitt:
It prevents the virus from making those inflammatory cytokines that kill you. It prevents the virus from killing the alveolar cell. And most importantly, it makes the cell make more surfactant, what we call up, regulating surfactant.
VIP the perfect arrow
Dr Javitt:
So it's kind of like a perfect arrow to hit this target. And we didn't invent it, got invented it. But we have put it in the form of a drug that people are using intravenously, like they have back in the ICU. And there's a tube that connects it to your arm and you get it into your blood.
Dr Javitt:
And in a couple of weeks, we're going to start giving it to people in inhaled form for earlier infections with covid-19. So that's kind of our story in a nutshell.
VIP and antiviral and immuno modulator
Dr Yogendra:
And Dr. Javitt, it's interesting and correct me if I'm wrong. Well, when I was looking through the mechanism of action and just reading the manuscript, it seemed to be that RLF one hundred almost has both antiviral. I was I was looking at it as an antiviral and also as an immuno modulator. Would that be fair to call it an antiviral and an immunomodulatory or.
Dr Javitt:
It is definitely both. We're going to name it as if it's an antiviral. We're actually trying to name it for Dr. Said, who discovered it in 1970, but it actually has both properties. So there's 50 years of scientific research showing that the IP blocks inflammation in the lung in all kinds of different models.
Dr Javitt:
If you pour hydrochloric acid into a mouse's lung and give it VIP, you can rescue the mouse if you take lungs that are going to be transplanted and give them VIP while they're waiting to be transplanted, you preserve lung tissue.
Dr Javitt:
This molecule is the reason that human beings can inhale smoke and the lung can repair itself. So it's got strong anti inflammatory properties. But in the case of the coronavirus, it's got strong antiviral properties as well.
Dr Javitt:
Now, I don't know if it has antiviral properties elsewhere in the body. It's not like a generalized antiviral drug, but it happens to stop this lethal virus in its tracks right at the site where this virus is doing the most harm.
Dr Javitt:
And the reason that's important is because my colleague, Dr. Yusuf in Houston, Methodist, started seeing this rapid recovery in some patients who who have covered 19 infection. And as I said, it's kind of the the worst of the worst patients, people who are too sick to get into our regular clinical trial. So will your readers be upset if I actually show them some x rays?
Dr Yogendra:
Oh, I think I think we would love it. We're all a bunch of science and medicine junkies, so the more the better.
XRAYS SHOWN
Dr Javitt:
Well, this this this is work that the Houston Methodist team has published on the SSRN Server. So anybody who wants to go find it and download it can, but as far as we know, nobody else has reported this kind of improvement with a coronavirus.
Dr Javitt:
So assuming you're not a radiologist and my wife, who is a radiologist, reminds me all the time that I'm not a radiologist, white is generally bad and black is generally good when it comes to a chest X-ray, unless you're looking at the heart right in the middle, which is always white.
Dr Javitt:
So here are three patients, three different patients where you see that the typical appearance of covid-19, where it's basically taking a nice, clear long and looks like it's filled with cotton candy. They call it a brown glass appearance.
Dr Javitt:
Well, here are those same three patients after they got the start of treatment with VIP. And you can see that the lung is starting to clear. You can see that looks much more black than it did over here. This probably is the most dramatic one. And even out of 10 days you're seeing.
Dr Javitt:
Pretty reasonably normal or much more normal looking lung and you're an anesthesiologist. I'm just a dumb eye surgeon. But I mean, why don't you tell your viewers what what you're seeing in those X-rays?
Dr Yogendra:
Because you're seeing dramatic improvement in the lung field. Both both both lungs, I think within a day, one to two days. That's pretty remarkable. I mean, those are. I'm not even looking at the ten days. I just think when I'm looking at the forty eight hours into twenty four hours and those two patients on the second and third patients, that's pretty impressive results. Very impressive.
Announces 21 Patient preprint
Dr Javitt:
So sometime next week, you're probably going to see similar results in twenty one patients. And it's not my work, it's that it's the Houston Methodist team where we're doing this extraordinary work, it's we have not had somebody show us this kind of improvement in covid-19 before now recognize that this is not a randomized controlled trial.
Dr Javitt:
This could be a placebo effect. It could be that these people would have gotten better on their own. And at the end of the day, the only way to prove that it's the drug that's doing this is to do a randomized controlled trial where some people are getting drug and some people are getting placebo. And that trial is underway. So far, about eighty six, Eighty seven patients have been enrolled.
IDSB 102 patients
Dr Javitt:
Our Independent Data Safety Board is going to take a look when one hundred and two patients have been enrolled. But meanwhile, we're seeing these early results in the people who were too sick to get into the trial. Now, not only do they have this kind of change in their X-rays, but right across the board,
Dr Javitt:
they've had improvement in their blood gases. So their blood oxygen has improved substantially along with their x rays. And people talk a lot about cytokines, which is a kind of a scary sounding word. And it ought to be scary because that's kind of what kills you the quickest in an covid-19.
Dr Javitt:
Let me see if I can make this come up for you. And. And the reason is when these set of crimes get loose in the They just cause all kinds of havoc. Well, a lot of people talk about IL-6 as an inflammatory cytokine and there have been a lot of anti IL-6 drugs that have been tried and covid-19 none of them have worked.
Dr Javitt:
But all of those drugs are drugs that are designed kind of like sponges to mop up the inflammatory cytokines after they have already been spilled into the bloodstream. Kind of like trying to mop up a glass of milk after it's been spilled compared to not spilling it in the first place.
Dr Javitt:
Well, as I told you early on, what this drug does, in addition to blocking viral replication, is it blocks the formation of cytokines in the lung cells. And this the zero.
Dr Javitt:
That's where patients started out in this study. And this is the first one patients who have been looked at in the open label study. And you can see that nearly all of them had a drop in interleukin six.
Slide Blood gases
Dr Javitt:
That's the cytokine that most of these map drugs, (Spelling uninteligleb :post ilslism ) MAB and other MAB drugs have targeted. You're seeing I mean, that is an average 80 percent reduction in aisle six in the sickest of the sick patients.
Dr Javitt:
And again, this could have been a placebo effect is there's no no denying that these twenty one patients could have gotten better just because they got better. But it's pretty encouraging. And we can't wait until we're able to take a look at the placebo controlled data.
Dr Yogendra:
Yeah, and you brought up an interesting point, Dr. Javitt, where the patients from the Houston Methodist, they were the sickest of the six, at least six patients when I was looking through there, their past medical history. I think that was a patient who had double lung transplant, coronary disease, diabetes.
Dr Yogendra:
I mean, these were not representative of the general public. And you were able to show some positive, obviously not some, but quite significant positive outcomes.
Dr Javitt:
Well, not me. It's Dr. Yusuf and his team. But, yes, they they really demonstrated extraordinary outcomes. And remember, everybody who gets considered for our trial is in the ICU with respiratory failure. So these are the people who were in the ICU with respiratory failure who were too sick to get into the trial.
Dr Javitt:
You probably know about a treatment called ECMO where your lung is nonfunctional to the point where they have to take the blood out of your body, add oxygen and put it back into your body.
Dr Javitt:
Well, five of the patients who are going to be reported next week were on ECMO And without stealing Dr. Yosuff surprise for next week for those people who are alive today. So we're excited by what we're seeing.
Dr Javitt:
We hope that what we're seeing is not a placebo effect, but given that the mechanism of action and given the brand new proof, because it's only in the last two weeks that our friends at the Oswaldo Cruz Institute in Brazil prove that the IP blocks the replication of coronavirus in the cell.
Dr Javitt:
Now that we understand the mechanism of action, the clinical results we're seeing kind of makes sense to us.
Dr Yogendra:
So in terms of the dosing, so the patients in this trial were getting the IV, the intravenous RLF-100, is that correct?
Dr Javitt:
They were, because these are people who are on ventilators. The lung is just full of inflammatory material. And we thought that if we gave this by inhalation, it just wouldn't get where it needs to go. Now, normally, drugs that are in the bloodstream don't get to the lung cells very well.
Dr Javitt:
That's why people with asthma inhaled the drugs they need instead of getting them by mouth or by injection. But in covid-19, when the lung starts breaking down, all of a sudden you can give a drug by intravenous drip and it actually gets through to the lining of the lung, which only shows you how badly the lungs broken down.
Dr Javitt:
Now we're about to start a trial for people with earlier stages of covid-19 who are walking and talking and don't have respiratory failure. And they're going to inhale the drug in the hopes that it will keep the drug from replicating inside these lung cells and causing respiratory failure.
Dr Yogendra:
So that would that would be the mild to moderate and and then versus to severe critical getting the IV, the plan is for the mild to moderate the getting and so.
Dr Javitt:
That's On Clinical trials, which is the government's website for all clinical trials.
Dr Yogendra:
And in terms of the IV dosing, is it I think it was 12 hours every 12 hours or is it three doses? Could you talk a little bit about the dosing?
Dr Javitt:
Well, I'd like to say we invented the dosing, but actually the dosing was devised in two thousand five by Dr. Sami Said he was the man who discovered the IP in 1970. And if you ask why did it take them so long to try it?
Dr Javitt:
And people it took them so long because they had it in the most miniscule quantities. And finally in 2005 people started making it with proteins, peptide synthesis so he could get enough drug treatment trials.
Dr Javitt:
And he came up with this escalating dose of fifty and one hundred and one hundred fifty pico moles per kilogram, which kind of sounds Greek. Probably what your viewers want to know, Actually is Greek, is what your viewers want to know is that this sort of minuscule doses of this very, very potent peptide.
Dr Yogendra:
And in terms of the inhaled version of RLF, one hundred, would it be or are you anticipating what would be the anticipated dose? Is it like a couple of hours, someone that is, let's say that mild to moderate some respiratory stem symptoms will be?
Dr Javitt:
This is the first time we're trying it in COVID patients. So we don't know if we have the dosing right. But we do know that when this was given to patients with Sarcoid, which is a nasty, inflammatory lung disease, having them inhale for about five minutes, four times a day had a meaningful clinical effect.
Dr Javitt:
So we're going to start out with that five minutes, four times a day and take it from there. And it could turn out that we need more, could turn out that we need less. It's it's early days.
Dr Javitt:
The only reason we're able to do it at all is one of the big drug companies got interested in VIP back in the two thousands. And they did four years of animal testing because it's, it's extraordinarily difficult to get the FDA's permission to try a drug by inhaled dose in the lung.
Dr Javitt:
The lung is such a delicate organ that unless you prove in four species of animals that it's safe to inhale, the FDA won't even let you do a trial.
Dr Yogendra:
That's interesting Dr. Javitt, in terms of we get a lot of questions about the safety and adverse events, could you talk a little bit about any adverse events, serious adverse events with with RLF-100 that you have seen?
Dr Javitt:
That's a great question. And so far, more than one hundred people have been exposed, have been treated with this drug intravenously. So far, there has not been a single drug related, serious adverse event.
Dr Javitt:
The drug is is not without its side effects because it's a very potent hormone. And in fact, the way people got on to this, the way Dr. Saïd got onto this is there's a benign tumor that some people get.
VIPOMA https://www.merckmanuals.com/professional/gastrointestinal-disorders/tumors-of-the-gastrointestinal-tract/vipoma#:~:text=A%20vipoma%20is%20a%20non,and%20achlorhydria%20(WDHA%20syndrome).
It's pretty rare called a Vipoma, which is a fancy word for saying it makes VIP and those people would show up in their doctor's offices with with diarrhea, with flushing, sometimes with low blood pressure. And that's how VIP was discovered.
Dr Javitt:
So when you give this at high doses, you can see a lowering of blood pressure. And it can only be if you're talking about the intravenous form, that's never been seen with the inhaled form because not much of it gets into the bloodstream,
Dr Javitt:
But with the intravenous form where you're giving a high dose intravenously to try to rescue somebody with otherwise lethal respiratory failure in the ICU, the blood pressure can go down and the ICU doctors know how to use drugs as you do because you're an anesthesiologist called pressors to make the blood pressure go back up.
Dr Javitt:
So, so, so far, none of the doctors who have been ready for that effect have had a problem managing it. It can also cause diarrhea, causes diarrhea, and probably one in six patients who gets it in the intensive care unit.
Dr Javitt:
But that's also a side effect that's pretty easy to manage. And if you're talking about a drug that's potentially life saving, it's probably well worth it.
Dr Javitt:
In fact, when you think back to the last twenty five hundred years of medicine since Socrates, doctors spent at least twenty four hundred of those years giving patients diarrhea on purpose, we used to think it was good for you. So that, too, is a side effect.
Dr Javitt:
That's probably not too much of a limiting side effect. And it can cause flushing, but that's so far that's not been a problem for anybody.
Dr Yogendra:
And if you can get someone off a ventilator, prevent them from getting them off ECMO, preventing them from getting intubated and on ECMO and the side effect is a little vasodilation and diarrhea, a little flushing. I think a majority of people would sign up for that rather than have something invasive done to them.
Dr Javitt:
And quite frankly, they were signing up for that, Mostly don't know that they're signing up for that. It's their relative who's signing them up for that because they're mostly unconscious. Right. But we haven't seen any.
Dr Javitt:
So I think of that more as a drug effect and a side effect. That's what VIP does in some patients. But we haven't seen anybody who had any kind of serious consequence from that.
Dr Yogendra:
And so talking about I know you brought up the FDA and there they have a very strict guidelines and protocols and very high bar that they've set. And what are your expectations moving forward in terms of possibly getting an easy way or some sort of approval?
Dr Yogendra:
You have any sort of idea, like in terms of a timeline when some of this data will be available and to be presented to the FDA, where I just met with the FDA last week and was a very positive scientific meeting.
Javitt's Opinion of the FDA
Dr Javitt:
I've worked with FDA now for 30 years on different projects, and I'm just astounded at the way that agency has turned on a dime and focus themselves one hundred percent on how can they get good treatments to market quicker. The FDA takes a lot of grief and probably a lot of it's not deserved.
Dr Javitt:
Probably a lot of people go to the FDA with everything not fully baked. But the the things the FDA has done to try to help some of these drugs get to market quicker is astounding. They actually approved my investigational new drug application.
Dr Javitt:
That is what you file in order to be able to test a drug in humans in less than 48 hours. When I've asked to meet with them, they've responded that they'll meet within less than a week, typically the FDA standard for meeting requests in 60 days. So you'll never agree.
Dr Javitt:
One hundred percent, because it's a scientific debate and their job is to challenge both their engagement and their commitment to bring the drugs to market is nothing short of extraordinary.
Dr Yogendra:
And and that's great. I'm glad you're sharing that with me and the rest of my viewers, because there's always a lot of I think there's a lot of lack of understanding of how these regulations and regulatory boards like the FDA work.
Dr Yogendra:
And they're there for a reason, because I think especially in biopharma and biotech, that can be a lot of snake oil and people promising all sorts of things. And it's their job to filter that out.
Dr Yogendra:
So that's very encouraging that to hear that from you, because you hear in social media and people talking all sorts of conspiracy theories and how things are not promoted. But there's a protocol. There is a way of doing things.
Dr Javitt:
Since I've I've worked for four presidents of the United States. Some of them are sitting behind me. And I worked in the FDA for the commissioner and I've worked for industry bringing drugs through the FDA and I've worked as a professor advising the FDA.
Dr Javitt:
So I've seen the agency from all sides on our board. We have a former chief counsel of the FDA, a former associate commissioner of the FDA. People think of it as a, as a, board that kind of looks at stuff and says yes or no.
Dr Javitt:
But you should think of it as a hive of some of the best scientists in the country. When you go there to talk statistics, you're talking to experts, statisticians. When you go there to talk biology, you're talking to expert biologists and they're trained to be tough.
Dr Javitt:
That's why the United States has had really almost no dangerous drugs come to market that had to be recalled. And that's not necessarily been the case outside the United States. So there are times I've walked away from an FDA meeting, cursing and swearing and having to do more work than I thought I'd have to do to convince them. But it's a it's a real scientific debate. It's not some board sitting there saying thumbs up or thumbs down.
Dr Yogendra:
And that's why there's always a great feeling when there is some sort of approval or when the FDA comes with, you know, they have some positive news from any meetings you have with them because of that high standard. And I sort of equate that to me. And anesthesia taking my oral boards.
Dr Yogendra:
It's the worst thing I've ever had. I had to study for. But you have to pass that pass that threshold. And you have these two we have four doctors that are sitting grilling you for a couple of hours. It's the worst thing ever.
Dr Yogendra:
So, you know, when I hear about how the FDA works of regulated regulatory boards, there's a reason we have to meet that minimum standard. And it's tough. Otherwise, everyone would be throwing drugs all over the place.
Dr Javitt:
And I've got to tell you that when that phone call comes, when they call to say that you've been approved, they're even more excited than you are. they get graded on approving drugs they don't get graded on rejected.
Dr Yogendra:
So in terms of where we are to study, so we said next week you'll be reporting some data from the other twenty one patients that will.
Dr Javitt:
The Houston Methodist team will,
Dr Yogendra:
And then the other the other clinical trial to the phase two and three, that you're going to do an interim analysis at about one hundred. One hundred.
Dr Javitt:
Exactly. So that trials enroll a little over eighty five people. I don't know. The numbers may have changed in the last two hours at one hundred and two people or independent data safety and monitoring board will take a look and they'll tell us one of the few things they say this drug is dangerous, Stop the trial.
Dr Javitt:
Well, that was the case. We don't really know about the adverse events and we haven't seen them. They may say there's so little difference between the drug and the placebo group that the study is futile and can possibly prove a difference. So you got to stop the trial and think of something else to do.
Dr Javitt:
They could say you're on track. It looks like if you keep showing what we see, you're going to have a successful trial. So keep doing it. Or they could say that the difference between the drug and the placebo is so large that you ought to stop the trial because you've already proved your point. Those are kind of the things the DSMB can tell you.
Dr Yogendra:
That's that's pretty incredible. And Dr. TJavitt, besides Houston, are there any other centers in the hospitals in the United States and around the world that are using or trialling RLF-100
Dr Javitt:
In addition to Houston, actually, the first study site in which University of Miami and there's a very large hospital system also in Miami that's just joining the study, University of California, Irvine, University of Louisville. And probably by the end of the month, it's going to be more than 10 hospitals.
Dr Yogendra:
That's really exciting and and in terms of if I have a couple of physician friends of mine in anesthesia, in critical care, they've asked me if they had patients in the ICU, would if they wanted to try RLF-100, is it they would have to apply for an EIND or so.
Dr Javitt:
We've stopped the EIND process, the FDA's request, because they actually took the next step and gave us what's called an intermediate sized population expanded access program. (EAP)
Dr Javitt:
That means that instead of doctors filing their own emergency, you sign these. Now they've got to figure out how to dose drug, how to monitor it. We've written a protocol that anybody can get from our website.
Dr Javitt:
If they download the protocol, take it to their institutional review board and meet our criteria, then we'll set them up as the site that's able to use this drug under expanded access. And our criteria are pretty simple. We want the ICU to have treated one hundred patients with with 19 and respiratory failure.
Dr Javitt:
And we want the investigator to have treated at least 30 patients with covid-19 and respiratory failure, because these are these are sick patients. These are patients who have an incredibly high risk of dying. And we want our drug to be used in the best hands in a way that can help people the most.
Dr Yogendra:
And one other question I think it's always on everyone's mind is if if the FDA does given approval, obviously that's going to be a mad rush to everyone's going to want to to use the drug in terms of the scalability and production. Have has. Have you and your team sort of thought about that or have plans on looking into the scalability?
Dr Yogendra:
Because I'll tell you right now, I have tons of physician friends. I mean, I started talking to them about this drug and said, well, if this gets approved, we want it in a hospital, how do we get it?
Dr Javitt:
So we may be a small team, but we punch above our weight. Our chief of operations, Robert Tof, spent his career, Lilly and Pfizer. His last job at Pfizer was the commercial head of the entire neuroscience and pain division. So who was responsible for about 10 billion dollars of drugs? Our whole manufacturing program was put together by Dr. Rich Siegel, who was the head of the whole Johnson Johnson drug portfolio.
Dr Javitt:
So we built it the scale. We're about to announce a partnership with the largest supplier of inhaled sterile drugs in the United States. And we're about to announce a partnership with a very large, well-known public company that can get any drug to any hospital overnight. So, yes, we've built this to scale. By October, we should be manufacturing enough drug for 100,000 people each month.
Dr Yogendra:
That's incredible. And my last question for you, Dr. Job, is we focus a lot of our discussion looking at patients in the ICU, in the hospital. I mean, that's what we do as clinicians. But from a public health perspective, and I know we're both fellow nurse when we're looking at people that are outpatient, that are having symptoms, go see a clinical role for inhaled RLF one hundred and and also for the long haulers. The sort of people that are coming out of these infections.
Dr Javitt:
Well, so those are two very different questions, but we expect that half of people will enroll in our health study are going to be people who, in fact, are outpatient. And my son actually has put together a pretty nice patient adherence system where we've got what's called a nebulized or a little handheld device that lets you inhale drug that's connected by Bluetooth to the cloud.
Dr Javitt:
So we can know when somebody took their drug and also connected it to what's called a pulse oximeter, a little wrist watch that measures your blood, oxygen all the time. So remember, the in the middle of this pandemic, people are not able to come to clinics very well. We expect to be able to monitor both whether they're taking the drug and how it's working for them when they take it. So we do see ourselves treating this disease earlier and earlier with the hopes of keeping people out of the hospital.
Dr Javitt:
Now, your other question was, should people take this drug long term in order to help the lung repair itself? Probably, yes, but we have to do that study to be able to show it.
Dr Yogendra:
Now, if that's that's really that's really incredible, you have I mean, there's just a lot of different clinical and therapeutic options here for different phases of the disease. So it's a very, very exciting, exciting drug.
Dr Javitt:
Well, thank you. And, you know, people call it a drug for lack of a better word, but it's a drug like insulin's the drug, your body makes it. We're supplementing the body at a critical moment. And one of the things we learn from our colleagues in Brazil is they looked at twenty five people with critical covid-19 people on ventilators.
Dr Javitt:
And of those twenty five people, 12 lived in 13 died. The ones who lived have much higher natural levels of VIP in their blood compared to the ones who died. So the body knows what it's doing. We're just trying to help.
Dr Yogendra:
Yeah, and, you know, I think when you're looking at the mechanism of action, when you're looking at those those MABS, the monoclonal antibodies, I've always made an analogy. It's like they're trying to target the quarterback in the game, whereas whereas RLF one hundred is bringing new management and a new coach and sort of redirecting. I love it. I love analogies. I'm sorry.
Dr Javitt:
I'm going to steal that from.
Dr Yogendra:
Oh yeah.
Dr Yogendra:
Sure, absolutely.
Dr Yogendra:
No, I'm a I love analogies and everyone says you make too many analogies, but I'm also a big football fan too. So I sort of that's how I study and look at medicine. But that's what it takes a sort of a very different approach, but getting almost the same outcome. And I think in terms of the clinical application to inhale the nebulized form is is so huge. I think sometimes when people are not in medicine, don't understand the route of administration is key when you have an IV.
Dr Yogendra:
It really limits you in terms of outpatient and even people coming to urgent care. Obviously, there's the cost behind the IV setting up the fluid bags and the tubing, whereas an inhaled version, I mean, that's very convenient, quick, very little downtime. So I think a lot of potential.
Dr Javitt:
Thank you yet,
Dr Yogendra:
Dr. Jarvik. Thank you so much. I know it's really late where you are and you guys must be really busy. I appreciate you spending a little bit of time and sharing some of your insight. The slides are incredible. Really, really paints the full picture.
Dr Yogendra:
And I hopefully once we have more results, you'll be back on and you can talk a little bit more. You're sitting right down there. Can you two guests at a time? Yes. One, why don't we come back after Dr. Yusoff releases the next results and we'll both sit and talk with you?
Dr Yogendra:
That would be awesome. I would I would be very grateful. Appreciative that.
Dr Javitt:
Fantastic.
Dr Javitt:
Thank you, Dr. Javitt, and thank you, everyone. Thank you. We'll speak later. Thank you.
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