2020-10-15 Solebury Trout Webcast Featuring NeuroRX Dr. Javitt Speaks on NRX-101 & RLF100 (Aviptadil)
2020-10-15 Solebury Trout Webcast Featuring NeuroRX Dr. Javitt Speaks on NRX-101 & RLF100 (Aviptadil): Video automatically transcribed by Sonix
2020-10-15 Solebury Trout Webcast Featuring NeuroRX Dr. Javitt Speaks on NRX-101 & RLF100 (Aviptadil): this mp4 video file was automatically transcribed by Sonix with the best speech-to-text algorithms. This transcript may contain errors.
Introduction
Brian Korb:
Thank you for attending the private company showcase hosted by Celebrate Trout, Beman, Davis Falcon, sponsored by Capital Advisors. And my name is Brian Korb, managing director here at Solebury Trout. Before I introduce our next speaker, I would like remind you to please feel free to submit your question to the presentation by the Web platform. If we don't have time to answer the question, they will follow individually afterwards. With that, it's my pleasure to kick this off and introduce the first speaker, Jonathan Javitt, co-founder and CEO of NueroRX. Jonathan. Please go ahead.
Javit Begins
Dr. Jonathan Javitt:
Thank you so much for inviting me. It's exciting to be with you. Virtually hope to be with you in person this time next year. So it's an honor to be asked to talk about NeuroRx, a project that's really the best job I've ever had. And we have our slides up?
Brian Korb:
Yeah, they're , they're up.
Dr. Jonathan Javitt:
Wonderful. So our focus is on FDA breakthrough therapies. Addressing unmet medical needs, using special protocol agreements and other cost efficient drug development approaches, and our first two products are one for psychiatry and NRX-1010 for suicidal bipolar depression and PTSD. And SamiAir, or Aviptadil, which is a treatment for covid-19 respiratory failure. These are the patients with covid-19 that nobody else is touching. These are the people who are dying every day.
Merger With NYSE Company Announced
Dr. Jonathan Javitt:
We're at an inflection point in the company where we've signed a term sheet to merge with a NYSE company be publicly listed in the next two quarters. We currently have 50 million dollars in assets. So we're funded through data. We're raising an additional 50 million dollars prior to that listing so that we have the ability to open some new projects that we think will be exciting to the marketplace and to our investors. The funding for the remaining of the SamiAir development is contractually committed by Relief Therapeutics. A Suisse publicly listed company. And we have one hundred million dollar post listing commitment for funding from the GEM Global Markets Fund. So numerous banks are in the process of vetting us. We think that there's strong interest in covering us. And we look forward to seeing you in the marketplace or before.
Company Leadership starts with Robert Bestoff
We've built a company that's led by industry veterans, Robert Besttof, our chief commercial officer, who's also managing our clinical operations, his 20 years of neuroscience, drug development and Lilly. More recently, Pfizer led major portfolios in psychiatry and pulmonary disease, which is why he understands our covered products will. And has worked all over the world for Big Pharma.
Richard Siegel
Dr. Jonathan Javitt:
So our focus is not us, only Richard Siegel, who's just in the last two months retired and gone to consulting status with our company. In twenty five years of leadership at J&J and predecessor companies was the head of the J&J Drug portfolio and Rick structured our whole CMC operation. And we've literally shown that we can take a drug from concept into the clinic in less than 10 weeks.
Doug Nesto
Dr. Jonathan Javitt:
Doug Nesta has taken over as VP of Manufacturing. Doug is twenty five years at GSK, leading particularly peptide focused projects, which is critical given the peptide nature of our covid drug.
Ellis Wilson
Dr. Jonathan Javitt:
Ellis Wilson is also a 20 year industry veteran, started out in psychiatry at AstraZeneca. Most recently was the chair for all the COVID projects at PPD and.
Dr. Jonathan Javitt:
Phil Levin in our lead methodologies, test his name on more approved drugs than any statistician in history. So we've built a team that's serious and we've also built a board that's serious about helping us. Chayaim Herbits was the president of Teva International. Sherry Gleed, the former assistant secretary of Health for Policy, Dan Troy, former chief counsel of the FDA. Wayne Pynes, former associate commissioner of FDA. General McMaster, as you know, is the former National Security Advisor. We've built what we view to be the best and the brightest.
NRX-101 Background
Dr. Jonathan Javitt:
So our psychiatrist story actually starts with my younger, smarter, better looking brother danger. But who discovered back in the nineteen eighties that the reason for cycling causes acute psychosis? He used to be called angel dust is that it blocks the core of the NMDA receptor in the brain, and he was the one who discovered that mechanism. As a result, NMDA antagonists became widely discussed as a mechanism for schizophrenia and then... And led to more than six hundred scientific papers in that area.
Dr. Jonathan Javitt:
And then, lo and behold, Rob Berman at Yale came along in around two thousand and discovered that those same NMDA antagonists have potent anti depressant properties. He was giving ketamine to human beings in order to induce hallucinations and study the hallucinations. And they came back a day later and asked for more ketamine because they weren't depressed anymore. And that's led to a huge explosion in.
Dr. Jonathan Javitt:
The understanding of the treatment of depression and there are now a number of NMDA targeted antidepressants in clinical trials. You know about Axum. You know about RAMADA lot of both of those are. Blocking the NMDA receptor. And as a result, any time you directly block the power of the NMDA receptor, you have a high propensity for psychosis. High propensity for hallucination. High propensity for addiction. And for that reason, we've targeted the glycine site on the NMDA receptor, which is more like turning a dimmer than than flipping a switch. And the marketplace has reacted, as you know, quite favorably to this whole new mechanism of action. The challenge is that both Axum and Ramata have generally excluded patients with suicidal ideation, excluded patients with bipolar depression. And unfortunately, those are the people who die. Especially the people with bipolar depression. The reality is that if you know.
Dr. Jonathan Javitt:
I'm just waiting for this. There we are, if you know five people with bipolar depression, one of those people. I'm Sorry, if you know two people with bipolar depression, one of those two people is going to attempt suicide at some point. That's just the reality. That's the epidemiology. If you know five people with bipolar depression, one of those people is going to succeed in committing suicide. And at this moment in time, we're the only drug in the pipeline that addresses that problem. And we do it with a dual targeted mechanism where we've combined NMDA antagonist with a 5HT2A antagonist. And they balance each other's side effects. So the 5HT2A antagonist blocks the hallucinations caused by the NMDA drug and the NMDA drug blocks, the Akathisia caused by the 5HT2A drug. And because of that we've gotten the composition of matter patent, that covers us for at least the next 12 years.
NRX-1010 Proof of concept studies
Dr. Jonathan Javitt:
We now have more than five proof of concept studies, one of them being an FDA phase two study, saying that this drug blocks depression, block suicidal ideation. And most recently, we are in breakthrough therapy designation showing a statistically significant difference in maintenance of remission from depression and suicidal ideation in patients who got our drug NRX-101 compared to patients who got Lorazepam. The difference was statistically significant. It lasted for eight weeks, 40 percent of the Lorazepam patients relapsed and none of the patients on our drug relapsed. So if we prove that again in phase three, we expect to get a drug approval from FDA, particularly since we've already been awarded breakthrough therapy designation.
Dr. Jonathan Javitt:
Now, it's important to understand that this isn't just another anti- depressent. This is not going after the same old mechanism. We now understand that these NMDA antagonists really rewire the brain at a cellular level. You can see it with changes in the shape of the brain cells called dendritic-sprouting. And this is one of the hottest frontiers in neuroscience right now. Because for the first time, we're actually seeing the effect of psychiatric illness on how the brain works at a cellular and molecular level.
RLF-101 Aviptadil
Dr. Jonathan Javitt:
So we started out around this set of patents from from danger of it all focused on NMDA antagonists in the brain. And I was sitting at my desk minding my own business on March 1st, when Chris Brown, the chair of the GEM group, called. And said, you know, we have this asset sitting over in Switzerland and a bunch of file boxes. Hasn't been looked at for the better part of 15 years. But we think it might have a major opportunity for treating covid-19. And remember, March 1st, we hadn't seen the first patients on ventilators, but we knew what was coming because we saw it happen in China and Europe. And SamiAir, Aviptadil is a synthetic human basal active peptide. It's a natural twenty eight amino acid peptide that's made in the body. Primarily concentrated in the lung. And the reason it's so interesting and potentially so effective is that it blocks the exact mechanism in the lung that causes covid-19.
Dr. Jonathan Javitt:
So. We got this into the clinic in 10 weeks, the FDA gave us the IND permission to move forward in forty eight hours when we showed them the preliminary data we had. And, that preliminary data was primarily based on Sami Said's original study in 2005 where he treated eight patients with,ah,Who were on ventilators for acute respiratory distress caused by sepsis. All eight patients showed improvement. Seven of those eight patients lived to leave the ICU. And all seven of those people survive to twenty eight days.
Dr. Jonathan Javitt:
So the reason, the difference between covid-19 and just sort of a bad cold. The reason this virus kills people. Is that these spikes on the virus bind to the ACE2 receptors in the lungs lining in a very specific cell of the lung lining called the alveolar Type II cell. So it's a rare cell. It only it only takes up five percent of the inside of the lung. But that's the cell that makes the surfactant that enables the lung to transmit oxygen. If you knock out that cell, your lungs can move air in and out, but the air will move into the blood. At least the oxygen won't move into the blood. And that's why patients with covid-19 go into acute respiratory failure.
Dr. Jonathan Javitt:
What this peptide does and it's been doing it for as long as mammals have walked on the earth, is it binds to that same Type II cell. It blocks the replication of the SARS coronavirus in the Type II cell. It blocks the production of cytokines and the Type II cell. It blocks the cell death that's caused by the coronavirus. And it increases the production of surfactant.
Dr. Jonathan Javitt:
Theory is nice, data or better. So we have two trials that we've started. One we've just read out. It's a prospectively administered and administratively controlled trial of our drug versus standard of care (SOC) in the patients who were too sick to get into a randomized controlled trial. The other trial that's underway, of course, is our Phase three trial of VIP versus placebo in patients who have covid-19 with respiratory failure but don't have major comorbidity.
Dr. Jonathan Javitt:
So in this population of patients who had lung transplants, renal transplants, cancer, heart disease. People who were way too sick to randomize in our Phase three study. Twenty one consecutive patients were assigned to a Aviptadil (RLF-100) and twenty four controls. People who were treated in the same ICU at the same time by the same doctors, the nurses were treated with standard of care. And except for the fact that some got our drug and some didn't. They all got the same care.
Dr. Jonathan Javitt:
We announced earlier this week a nine fold advantage in survival with a Aviptadil (RLF-100) treated patients compared to standard of care patients. And that nine fold advantage was also seen in terms of recovering from respiratory failure. Now, in order to give you some context, the large Remdesivir trial was reported out on October 8th, and it did show benefit in the less severely acute patients.
Dr. Jonathan Javitt:
But in those patients who were on ventilators, Remdesivir was not at all better than placebo. Here we've seen a nine fold advantage and you're going to see that data in detailed form as soon as the journal that's reviewing the paper puts it up on their preprint server. We can also discuss that under CDA.
Aviptadil (RLF-100) X-rays and pO2 blood gases
Dr. Jonathan Javitt:
So. Ah, The nine fold difference in survival was also mirrored in terms of blood oxygen. It was mirrored in terms of ordinal scale. And, It was also mirrored on the x rays. So it's not common to see patients with covid-19 pneumonitis have rapid improvement on their x rays. And for those of you in the audience who are not radiologists, which I assume is the vast majority, white is bad and black is good on a chest x ray. White means that something's blocking the x rays from going through the lung, usually edema fluid. And this is what a cute covid-19 looks like within forty eight to ninety six hours, we were seeing improvement on chest x ray. And, Ah, we're going to publish all of the x rays. And by a week we're seeing pretty much clear lungs, both on chest x ray and CAT scan. So at least from our perspective and the perspective of just about every position we've shown this to, some of the differences we saw were profound.
NeuroRX Pipeline NRX-101
Dr. Jonathan Javitt:
So if you look at our pipeline. The bipolar study is moving forward. But is on hold right now only because we can't enroll patients until the psychiatry clinics are out of their lockdown phase.
Aviptadil (RLF-100) Study
Dr. Jonathan Javitt:
The Covid study is moving forward with incredible velocity. We expect to read out the Phase three trial by the end of the year. But, ah, two weeks from now, there's going to be a meeting of the data safety monitoring board (DSMB). And ah, they're going to review the first one hundred and two patients in the trial. They have the potential to see both futility, which we hope they won't see. Or perhaps they will see overwhelming evidence of efficacy. Either, which would lead to stopping the trial.
Aviptadil (RLF-100) Inhaled form IND
Dr. Jonathan Javitt:
FDA has given us a second, IND, to use this drug in inhaled form. In the hopes that we can prevent people with severe covid-19 but don't yet have respiratory failure from developing a critical covid-19 and going into the ICU.
SLIDE : PRICING SLIDE AVIPTADIL(RLF-100) IV $9000-$16,000 oper patient. RLF-100 Inhaler NO SET PRICING
Dr. Jonathan Javitt:
And in the studies I told you about, we demonstrated a savings of at least nine ICU days on average with our drug. So you know better than the size of the markets we're talking about.
NRX-101 Emergency Room Visit for suicidal Depression
Dr. Jonathan Javitt:
But on the bipolar depression side, one hundred fifty thousand Americans a year go to emergency departments with acutely suicidal bipolar depression. A million a year are treated in their psychiatrists offices for acute suicidality. So we have plenty of market opportunity. Brian is telling me that it's time to stop. And my last slide is the same as my first slide. So thank you for inviting me. I look forward to talking to you.
Brian Korb:
Thanks, Jonathan. I don't think we have any time for questions, but there was a big audience here and a lot of questions to the online system. So I think we'll try to get back to folks as we can. Thank you so much, Jonathan.
Dr. Jonathan Javitt:
Thank you.
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