Treatments from Gilead and Regeneron Move Forward in Battle Against COVID-19!
Some glad to be back and have a good show for everybody. We're GONNA talk about a few interesting companies. That had some good readouts this past little while as well as ones that are upcoming. So we're going to start by talking about axiom. Therapeutics and their readout in Alzheimer's Disease Agitation. Or then GonNa move on and talk about Gilead add in all the updates. We saw their Endesa of your trials. Never GonNa talk about another company. That has some. Kobe related. Work going on which is regeneration. And I usually don't talk about mid large-cap biotech but regenerate is is an interesting one. Especially because I've touched on their main compound lia in previous videos so I thought I'd do kind of a deeper look into them and we're GonNa talk about that in big detail so with that. Let's just get ready to it. And the first topic I want to mention is acts on therapeutics so their company that saw a huge runup in twenty nineteen with the development of their drug. Axs Zero Five. Which is a combination of Dextrathoraphan and Wellbutrin and they've already seen positive readouts in major depressive disorder with this compound as well as a couple of other ones and they saw mixed results with treatment resistant depression. But I think they're going to move forward with some trials any way to confirm that data but what they also wanted to to look ad. And this is the data that in presenting here is the effect of access zero five in Alzheimer's Disease Agitation so one of the symptoms associated with Alzheimer's disease is this agitate that comes along with it and it occurs in around seventy percent of all patients so that works out to six million people in the USA. So it's a pretty huge indication in one that I didn't really look at in serious capacity before I took a position because it was originally planned for that treatment resistant depression but I think the stock had a lot of potential. Besides that so. We saw a readout this week. That showed a significant improvement in this. Cma I total score in patients treated with excess zero five compared to both be appropriate riches or placebo and view pro free on its own. Didn't have a substantial effect on Alzheimer's Disease Agitation. It was only when it was mixed with desperate dextrathoraphan in excess zero five that it saw this improvement so this is very beneficial for the song. I think it opened on that day you know upwards of one hundred and change and then it fell back down. I think it closed this week at ninety but very positive for the company and they need to discuss with the FDA how they're going to move forward and whether or not this is GonNa be considered a pivotal trial for them so we might see some insights in their Q. One earnings call which is taking place on. May eighth but is definitely impressive for the company and this molecule is going to be a huge revenue driver for them once they get those filings through and get approval. So that's excellent therapeutics and I'm still holding onto the thirty shares that I bought so let's talk about Gilead and their drugs death severe. That's been investigated right now for the treatment of Cova Nineteen and the importance around rim of your has less to do with Gillian specifically and more to do with how it's going to be implemented in the hospital system and prevent them from being overburdened as states kinda revamp up their economies again because if from desktop here has an effect in it lowers the time in which patients need to be in the hospital. The chances of the hospital system being overburden reduces substantially since we can you know get these patients in and get them out quicker. So that's why remm desperately is so important and we saw originally that Gilead published a study with regards to the compassionate use only remedy severe and that was only a single arm study. That didn't have really great conclusions to be drawn from but since then we've seen results from four studies and I'm GonNa talk about these in some detail because we heard that Dr Bounty announced that there were significant results in that they're going to move forward and approve rendez severe for Cova Nineteen and we also heard on Friday that trump is going to announce the approved use of reinvest fear for this so the four studies that we got results for our this China study that was published in the Lancet and this was an underpowered study so they weren't able to find patients who enroll in this study so they just took the data can the study published in The Lancet. The next one is this. Niaid study that was also a randomized placebo controlled trial and then there were two phase threes. That Julia did call the simple studies. And this is to compare the ten day treatment versus the five day treatment and the reason why they did this I believe is because they don't really have the commercial capacity to produce unlimited rendez severe. So if they can show that the treatment of as severe works just as well with a five day treatment they can save more doses for more patients. Let's first talk about the China study which was published in the Lancet a little while ago and this was a randomized placebo controlled trial in Severe Cova nineteen patients and just to note that this was underpowered. Despite the fact that they did statistics on it there weren't enough patients to really get the power that they were looking for from the outset. And what we see here is that patients treated with Rendez. Aveer were more likely to die if you look at this. Kaplan Meier curve and the hazard ratio was one point two three. Which means that. If you were treated with reservoir you had kind of a twenty. Three percent increased risk of dying the other attract that. I'm showing here is the viral load. So one thing that I was hopeful to see is that Rendez released had an effect on viral loads and the one thing to note though. Is that these samples were taken only from the news. Affairs in the oral faring. So that's kind of your nose area and your throat but not your lungs. So there's a chance that there would have been a significant difference if swabs were taken or if they did some kind of leverage to get samples from the lung and see whether or not rendell spearheaded effect on viral loads. In in that capacity the study also looked at length of hospital. Stay in that was also not significant in this study although the safety was actually okay. So that's one positive outcome from all this but given that this study was underpowered. We need to take these results with a grain of salt. But it's not super encouraging. That REMM has no profound effect in these patients specifically but they also went ahead and did this. Niaid study so we look at bat study. They looked at one thousand sixty three patients and these were hospitalized. Kobe nineteen patients so still in the severe range. And here's what the press release said preliminary results indicate that patients who received rendez severe. Had A thirty one percent faster time to recovery than those who received Placebo and the P value here is less than point zero zero one specifically the median time to recovery was eleven days for patients treated with severe compared with fifteen days for those who received. Placebo results also suggested a survival benefit with a mortality rate of eighty percent for the group receiving Rendez severe versus eleven point six percent for the Placebo Group and the P value here was point zero five nine so this is the study that I think Dr Found. She was referring to saying that there was a significant benefit to rendez severe treatment. And I definitely see a benefit if this is the difference in the time to recovery. The survival didn't have a significant effect. But even if there isn't a significant survival benefit if there is a benefit to the time to recovery. I still think that is profound and we'll be able to help the burdening of the hospital system. Which is what I was referring to earlier in talk so we still haven't seen a lot of details in this. Study some stuff that I'd love to see. Our viral loads led to look at the safety to see more details in in the effects. Endesa there had so. We don't really know exactly what's going on. But this is the study that I think the. Us government is looking at to say whether or not it is a drug with an effect that will be rolled out in the country and it looks like that's going to happen even before we are going to see the details of that study but it is what it is and then the last studies. I wanted to talk about. Are these simple studies from Gilead and this is an open label trial that looked at a five day treatment or attend day treatment and the results are that the study demonstrated that patients receiving a ten day treatment course of Amdex aveer achieved similar improvement in clinical status compared with those taking five treatment course and the odds ratio here is point seven five with a ninety five percent confidence interval of point. Five one to one point one two on day fourteen so this is good news. It shows that they only need to treat rim desperate for five days and it's GonNa be not significantly different than they treated with ten days and we've been seeing a lot about Gilead having around a million doses of rendez severe before the end of the year so given that only five day treatment is needed. They're going to be able to save rim desperate for more patients. And that's a good thing because like I said I don't think Gilead expected at the beginning of the year have to roll out the commercialization of severe. But they're gonNA have to do that. Some capacity and in this way can be able to save some doses for a lot more people and I I put a little note here about the safety so breathe three or higher liver enzyme. Lt Elevations occurred in seven point. Three percent of patients with three percent of patients discontinuing rimmed as severe treatment due to elevated liver tests. So this is kind of a negative thing that is going to affect a decent number of patients because I think a lot of the comber abilities of Cova nineteen patients are issues related to their liver