Just now, markets are waking up to the news that President Donald Trump and First Lady Melanie have tested positive for COVID-19. Regardless of where you stand on the political spectrum, this is sad news because he is still the President of the United States. However, the good news is that there are treatment options available. The first thing President Trump needs to do is ignore Anthony Fauci about Remdesivir. The second thing he needs to do is watch this Ted Talk and educate himself about Leronlimab and CytoDyn.
The third thing Trump needs to do is call UK Prime Minister Boris Johnson. My colleague Chris Sandburg focused on the linkage between CytoDyn and Boris Johnson after Johnson tested positive back in March, which you can read here.
Short And Distort
The bulls have had to endure relentless attacks from the shorts after reporting that Leronlimab had missed one of the primary endpoints in their Phase II study for mild-to-moderate COVID-19 patients. However, Phase II studies are designed to help determine what the company will target in a potential Phase III trial. A drug can miss several endpoints in a Phase II study but still crush one, which could be enough to justify running a Phase III. Just because Leronlimab missed one primary endpoint doesn’t mean it doesn’t work but bears want the common retail investor to think that there is no way it will be approved for COVID-19.
We have covered CytoDyn extensively here at Insider Financial. We know many are sitting on losses as CytoDyn has been under relentless pressure from the shorts being led by the so-called “Night King of Biotech” Adam Feuerstein who spreads non-stop FUD about Leronlimab because he has an ax to grind with CytoDyn CEO Nader Pourhassan. The Night King’s day is coming once Leronlimab is approved by the FDA.
Trump and COVID-19
There has been a lot of misinformation when it comes to President Trump and COVID-19. While we won’t debate what has happened in the past, we will focus on going forward and the fact that Trump has tested positive. He needs treatment, plain and simple!
First, COVID-19 has now entered his body. Doctors need to shut off viral replication. Gilead’s Remdesivir has proven to NOT shut off the virus. For Trump, three things need to happen in the virus:
- Quiet the cytokine storm
- restore immunosuppression
- drop the virus
COVID-19 infection is accompanied by an aggressive inflammatory response with the release of a large amount of pro-inflammatory cytokines in an event known as “cytokine storm.” Cytokine storm (CS) is a critical life-threatening condition requiring intensive care admission and having quite high mortality. CS is characterized by a clinical presentation of overwhelming systemic inflammation, hyperferritinemia, hemodynamic instability, and multi-organ failure, and if left untreated, it leads to death. The trigger for CS is an uncontrolled immune response resulting in continuous activation and expansion of immune cells, lymphocytes, and macrophages, which produce immense amounts of cytokines, resulting in a cytokine storm.
Cytokines are an essential part of the inflammatory process. Cytokines are produced by several immune cells including the innate macrophages, dendritic cells, natural killer cells, and the adaptive T and B lymphocytes.
Accumulating evidence suggests that some patients with severe COVID-19 suffer from a “cytokine storm.” Analysis of cytokine levels in the plasma of 41 COVID-19 confirmed cases in China revealed elevated levels of IL-1β, IL-7, IL-8, IL-9, IL-10, FGF, G-CSF, GM-CSF, IFN-γ, IP-10, MCP-1, MIP-1A, MIP1-B, PDGF, TNF-α, and VEGF in both patients admitted to the ICU and non-ICU patients compared to healthy adults. All patients included in the study had pneumonia and 1/3 of the patients were admitted to ICU and six of these patients died.
Now, President Trump doesn’t have the Cytokine Storm yet. The key is making sure it doesn’t turn into one. Thus, the goal is to quiet the Cytokine storm. Suppress it before it becomes one.
Intensive immunosuppressive treatment with high dose glucocorticoids, followed by an interleukin-6 (IL-6) receptor antagonist where needed, accelerates respiratory recovery and reduces deaths in patients with COVID-19-associated cytokine storm syndrome (CSS).
Recognizing patients with COVID-19-associated CSS is very relevant since these patients have a worse prognosis and a high mortality rate. We have evidence that treatment suppressing the immune system helps these patients fighting against the disease.
Government Red Tape
Besides the FUD spread by Feuerstein, the other major, a major roadblock for CytoDyn has been government red tape. Here’s what has been happening.
Both the FDA and UK’s MHRA both want to see interim data from the Phase 2 study, CD12, in severe/critical patients before deciding on emergency use authorization/fast track of leronlimab.
Data from 60 mild-to-moderate patients in the Phase 2 study, CD10, shared with MHRA on September 9. Maybe a candidate for early access program. MHRA wants these data, along with results from other ongoing studies, to be submitted for review. Compilation in process. Site selection for UK study in process.
Working with the FDA on the protocol for a Phase 3 study assessing four weekly injections in moderately ill COVID-19 patients. Some of these will be considered “long-haulers,” those who have been infected with SARS-CoV-2 but have never fully recovered. Leronlimab may be effective in these patients considering its ability to cross the blood-brain barrier.
CytoDyn believes the quickest path to approval is moderately ill patients including long-haulers.
President Trump and Therapeutics
For COVID-19, we need a therapy that keeps people out of the hospital and saves lives. A simple shot would be optimum. Something that you can take and then feel better in a few days. This is what President Trump wants and said so prior to contracting COVID-19.
There are only 3 COVID-19 leading therapeutics (Ampion, Tocilizumab, and Leronlimab) that are classified as shots. Ampion which is made by Ampio Pharmaceuticals (NASDAQ: AMPE) is currently classified as a shot but their COVID-19 product is likely to be via intravenous or a nebulizer. So they are a contender but Tocilizumab which is made by Roche Holding (OTCMKTS: RHHBY) failed to meet its endpoint in a phase 3 study.
The top pick and only the second drug to file for Emergency Use Authorization (EUA) during this pandemic is leronlimab. Filing a EUA means the drug company CytoDyn feels there is such a compelling case for approval of leronlimab that they are requesting the FDA to act now. It filed the request on August 17th and has received little to no fanfare from any of the major media outlets despite successfully reaching multiple endpoints in phase 2 clinical trial.
On the contrary, to great fanfare despite its shaky results, Gilead Sciences (GILD) was the first to file a EUA after it released “positive data” from the National Institute of Allergy and Infectious Diseases’ (NIAID) study of remdesivir for COVID-19. The EUA was controversial because Gilead changed the endpoints and although Gilead classified remdesivir as an antiviral, the drug had no impact on the viral load, no effect on mortality, and a relatively small reduction in hospital stay. Additionally, the safety profile is not optimal. Despite these shortcomings, it was approved on May 1st which was two days after the results were released.
Severe Adverse Events (SAEs)
Leronlimab is only the second COVID-19 drug in clinical trials to hit an endpoint that wasn’t changed midstream, like that of remdesivir. However, leronlimab’s clinical results are even more impressive. It’s pretty surprising that in a pandemic no one seems to be paying attention to a therapeutic that has both an impeccable safety profile and that actually lowered Severe Adverse Events (SAEs) by 64% compared to placebo, and also showed significant efficacy.
A reduction of SAE’s in a condition where death is a probable outcome is the definition of efficacy. Since most drugs have side effects that result in SAE’s, a significant reduction can be a reason for approval.
Not only did leronlimab reduce SAEs, but it also improved patients’ NEWS2 scores. The NEWS2 score measures efficacy and leronlimab showed a statistically significant (p < 0.023) improvement in the score that measures respiratory rate, O2 saturation, supplemental oxygen, temperature, blood pressure, heart rate, and level of consciousness. The patients on leronlimab improved 50% while the placebo group only improved by 20%. This index is a quantitative and objective way to measure COVID-19 patient distress. Leronlimab achieved this remarkable improvement on day 3 of the 14-day study.
More impressively, the drug worked in a Mild to Moderate patient population where there is low expression of symptoms and an unknown chance of death. In order to show efficacy, the drug needs to work extremely fast because most, if not all, mild to moderate patients recover in 4 to 7 days, according to data from CytoDyn’s placebo arm. The delta between the active drug group and that of the placebo will barely register on day 14 because a majority of patients get better on their own. So it was almost impossible for them to succeed in this trial unless they showed an effect on day 3 and that’s precisely what happened.
We still believe Fauci as a political agenda. Matter of fact, Democratic challenger Joe Biden said that he would keep Fauci on if he wins the election. Fauci should have endorsed leronlimab by now, but hasn’t.
The FDA’s criteria are pretty black and white when it comes to EUA. Under section 564(c)(2) of the Act, a EUA may be issued only if FDA concludes “it is reasonable to believe that: (A) the product may be effective in diagnosing, treating, or preventing—(i) such disease or condition…; and (B) the known and potential benefits of the product, when used to diagnose, prevent, or treat such disease or condition, outweigh the known and potential risks of the product.” The purpose of a EUA is to provide more timely access to lifesaving drugs when there are no adequate and approved options and when we simply cannot afford the snail’s pace of the typical approval process.
Leronlimab is perhaps the poster child for a EUA because there is no grey area in meeting any of the requirements. There is clearly a benefit of the drug whether it is in the enormous reduction of SAEs, the NEWS2 index that shows the reduction of stress on COVID-19 patients, the reduction in the number of people going on ventilators, or the reduction in the total symptom score. Many pathways demonstrate efficacy and there is clearly no risk in taking the drug. As an aside, ALL the SAE’s that were noted in the patients that took leronlimab were not related to the drug. So what do you call a drug that makes all your side effects go away and eliminates the chance that you will get complications? It’s called leronlimab, yet has not been approved.
It is imperative that President Trump is made aware of leronlimab now. We urge all readers to like, share, and spread this article on social media. President Trump’s health and the health of the nation are at stake. Give Trump Leronlimab and CytoDyn shareholders will get the catalyst they have all been waiting for.
As always, good luck to all (except the shorts)!
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Disclosure: We have no position in OTCMKTS:CYDY, or any of the securities mentioned. We wrote this article ourselves and it expresses our own opinions. We are not receiving compensation for it. We have no business relationship with any company whose stock is mentioned in this article. Insider Financial is not an investment advisor and does not provide investment advice. Always do your own research and make your own investment decisions. This article is not a solicitation or recommendation to buy, sell, or hold securities. This article is meant for informational and educational purposes only and does not provide investment advice.