Interpretation Of Cytodyn's Mild-To-Moderate COVID-19 Results
Jul. 26, 2020 6:41 PM ET|
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About: CytoDyn Inc. (CYDY)
Thomas Barnard
Thomas Barnard
Special situations, Deep Value, long/short equity, Growth
Summary
Leronlimab patients had 63% less Serious Adverse Events than control subjects in mild-to-moderate patients.
58% less patients were effected by a Serious Adverse Event.
Leronlimab reduces the viral load in patients to zero in 14 days.
Company plans to pursue an EUA (Emergency Use Authorization) for an unmet medical need.
The Proposition
The proposition of Cytodyn (OTCQB:CYDY) is that its humanized monoclonal antibody molecule, leronlimab, which blocks the CCR5 receptor on T cells and macrophages can prevent cytokine and chemokine mischief including metastasis and in the present results, the cytokine storms in the lungs resulting in acute respiratory distress syndrome (ARDS) in Covid-19 patients which leads to ventilators, and many times, in death.
Cytodyn reported results on Tuesday morning, July 21, of a Covid-19 trial in which there were 28 control (or placebo) subjects, and 56 test subjects. Please find their Press Release here.
Viral Load Goes to Zero
Before I get into the numbers, I think it is important to bear in mind what Dr. Bruce Patterson, former head of Virology at Stanford, has stated a couple of times now (once in his TEDx Talk, and once in his talk with Dr. Mobeen Syed) that the viral load of the coronavirus drops to zero in 14 days. The way I interpret that it means that after 14 days there is no further infection or disease coming from the virus. But the body still needs to stop the on-going inflammation.
Let that sink in. Eventually, the Covid cannot be found in the blood, which has to be an absolute good in the treatment of the disease.
Dr. Patterson said in his TEDx Talk that leronlimab does three things in Covid.
1. It quells the cytokine storm in the lungs
2. It sets right the immune system, which can be tracked by blood markers – CD4, CD8, IL-6, CCL5.
3. It reduces the viral load (ultimately, to zero)
By Patients
The company reported that 5 of the leronlimab subjects suffered Severe Adverse Events (SAEs) out of 56, and it reported that there were 6 subjects out of 28 control subjects (who got a placebo). Since the control group is exactly half of the experimental group (leronlimab), you could double the placebo group to see more closely what has happened. Apples with apples.
12 out of 56 of the control group suffered SAE’s - 2x of (6 out of 28)
5 out of 56 of the leronlimab group suffered SAE’s
That means there were half as many, actually less than half patients as many suffered Severe Adverse Events with leronlimab.
One patient died after 33 days in an event unrelated to leronlimab.
By Events
The company reported there were 19 Severe Adverse Events in the study. There were 11 SAEs in 6 control (placebo) patients, and there were 8 SAEs in the leronlimab group. Again doubling the control group, we have (apples with apples):
22 SAE’s out of 56 in the control group – 2x of (11 out of 28)
8 SAE’s out of 56 in the leronlimab group
Again, the leronlimab group has less than half the number of SAE’s than the control/placebo group, so, it would be more desirable to be in the leronlimab group.
I take these to be very happy results, and any sensible person would much rather be in the leronlimab group. We will get efficacy numbers soon, and eventually a safety peak at the severe-to-critical. Dr. Pourhassan has already stated a number of times that there are quite a few deaths in that study.
Certainly, it will be important to know in severe-to-critical study at what point in the disease progression the patient got the drug. Presumably, the study will try make this the same, and to eliminate secondary conditions, but I think some stuff will still get past the filters. In the compassionate use cases, the evidence plainly shows that if the secondary conditions are serious enough, for example, in transplant patients under immune suppressive drugs, the medication does not work well enough to guarantee survival, though I think it was Dr. Bruce Patterson’s point that even in cases where the patient does not survive, the blood work is showing improvement up to the end.
The company plans to pursue an EUA (Emergency Use Authorization) for an unmet need. Clearly, use of leronlimab would benefit the public.
Scientists and investors will not know the full extent of leronlimab’s usefulness until the Phase III is completed, though a safety peak will be revealed perhaps four weeks after half of the 390 subjects are enrolled. Perhaps in August
Conclusion
Even though the stock went down after the release of these results, and media is ignoring this work, BARDA is ignoring this work, the private foundations are ignoring this work, it is, nevertheless, important work in reducing suffering.
As far as investors are concerned, I would recommend that they pay attention to the results in all of the company’s trials, which have been stunning. In triple negative breast cancer CTC’s (circulating tumor cells) have gone to zero after 3 to 6 weeks of once-a-week injections. In HIV, viral load goes to zero (or undetectable), and now again, in Covid-19 the viral load goes to zero.
I would recommend that investors hold fast to their shares, ignore the propaganda of short sellers, and stay the course.