CytoDyn Inc. (OTCMKTS:CYDY) may be the target of a White House press briefing very soon. A couple of social media influencers like Thomas Landstreet, Marc Siegel, and Nicole Saphier are spreading the word. For COVID-19, we need a therapy that keeps people out of the hospital and saves lives. A simple shot, just like what President Trump alluded to in his campaign speech on Tuesday would be optimum. Something that you can take and then feel better in a few days. Though President Trump is the Promoter in Chief let’s assume he knows something.
“Therapeutics to me are more important right now. You go into the hospital, whether it’s a transfusion or whether it’s a shot, and you feel better two days later, a day later, or three days later. But that would be a great thing and we’re very close.”
There are only 3 COVID-19 leading therapeutics (Ampion, Tocilizumab, and Leronlimab) that are classified as shots so it’s shocking that the White House Press Corps hasn’t asked which drug he is referring to. 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 and not likely the topic in this podium discussion.
The top pick and only the second drug to file for Emergency Use Authorization (EUA) during this pandemic is called leronlimab. Filing an 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 a phase 2 clinical trial.
On the contrary, to great fanfare despite its shaky results, Gilead Sciences (GILD) was the first to file an 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 end points 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.
Leronlimab is only the second COVID-19 drug in clinical trials to hit an endpoint that wasn’t changed midstream, like that of remdesivir. Dexamethasone, a widely available steroid was the first to hit an endpoint that showed that they reduced the risk of mortality by 20% in a subset of hospitalized patients. 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 both has an impeccable safety profile and that actually lowered Severe Adverse Events (SAEs) by 64% compared to placebo, and also showed significant efficacy. To put this measure of drug safety into perspective, here’s what researcher Dr. Jacob Lalezari, MD said about the reduction in SAE’s.
“They’re not endpoints that we’re used to seeing, because we’re not used to seeing a reduction of SAEs in clinical studies. I’ve been the P.I. of about 300 studies and I have never seen that before, but SAEs are medically significant events, like deaths and intubation.”
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, it 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 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 a 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 at 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.
What’s really on people’s mind is how the FDA will react to a therapeutic that clearly demonstrated efficacy in a large randomized controlled trial. We know Fauci is a big fan of randomized controlled clinical trials. In an interview with Stanford School of Medicine Dean Lloyd Minor, Fauci spelled out his criteria for endorsement:
“The two drugs that have now definitively shown to be beneficial in advanced disease were proven by a randomized placebo-controlled trial. So clinical research and clinical research infrastructure is a very important part of the response to outbreaks. And we’ve already proven that, and I think we need to make sure we appreciate that going forward.”
Unless Fauci has some political agenda we should expect him to endorse leronlimab now that it is the third drug that has demonstrated efficacy in a randomized placebo-controlled trial. It’s incumbent upon reporters to ask him to opine on the trial now that it’s been submitted to the FDA. The FDA’s criteria is pretty black and white when it comes to EUA. Under section 564(c)(2) of the Act, an 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 an 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 SAE’s, 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 and it appears to be on the verge of approval.
The FDA has also boxed itself into making a quick decision on an EUA with the drug because it stopped allowing the company to give Emergency IND’s (EINDs). Too many physicians and potential patients know about this drug and without a pathway to get the drug as a treatment there could be a strong political backlash. It’s unthinkable that a drug that has no side effects and actually lowers them would be kept from the American people during a pandemic. The FDA has only two choices at this point, it needs to give guidance on a phase 3 trial design or it can grant the second EUA for COVID-19. The FDA cannot drag its feet because if it requires a phase 3 trial it needs to let CytoDyn know right away so they can begin recruiting patients. As time passes it becomes more likely that the drug will be approved as the FDA weighs their options.
Operation Warp Speed was designed to ensure that promising vaccines and therapeutics were produced in large enough quantities to prevent a shortage should they be approved. On the Dr. Drew Show, Dr. Patterson broke the news that he and CytoDyn were aware of Operation Warp Speed. The agency’s involvement could bring a flood of funding that would shore up production and the completion of clinical trials. Adding to the approvability is CytoDyn’s BLA filing for HIV as well as its ability to be manufactured at scale and distributed widely. CytoDyn’s agreements with Samsung Biologics will ensure that leronlimab can be distributed to enough patients who need it and therefore leronlimab is worthy of the FDA’s consideration for EUA.
Mainstream media seem oblivious to the impending approval of leronlimab and the shockwaves it might create. Instead, the media is myopically focused on vaccines and social distancing measures which actually appear to be perpetuating the fear of dying from the disease. Leronlimab has the potential to be a game-changer, to defang COVID-19, and to take dying from the disease off the table. Many people have been waiting for a vaccine to be approved because they feel that it will lead to herd immunity and allow the reopening of the global economy. The bad news is that it’s just way too early to tell if the vaccine strategy is going to work.
Approving this drug could lead to a reopening of our economy and is in the national interest. The bread crumbs seem to indicate that the drug works incredibly well and that the government through Operation Warp Speed (OWS) is working to secure a healthy supply for the American people. The drug exceeds all the criteria for an EUA. The only viable risk is political, as each party tries to claim the solution to the pandemic as their own.
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Disclosure: Insider Financial and its owners do not have a position in the stocks posted and have posted this article for free without editorial input. This article was written by a guest contributor and solely reflects his opinions. The author may hold either long or short positions in the securities discussed.