CytoDyn Inc. (OTCMKTS: CYDY) announced groundbreaking safety results from its phase 2 Mild to Moderate COVID-19 trial today. The company reported a statistically significant reduction in Severe Adverse Events (SAEs) over placebo. In Gilead Sciences (NASDAQ: GILD) SIMPLE Trial, remdesivir had Adverse Events as high as 55% versus 45% in the Standard of Care (SOC). In April, this paltry trial data earned remdesivir an emergency use authorization. In comparison to leronlimab, remdesivir had significantly worse safety data and only a 4 day reduction in the time to recovery. In the active arm, leronlimab only had 14% SAEs versus 39% SAEs in the placebo group. Dissecting the data even more there is an even more powerful finding. The press release stated “none of the SAEs in leronlimab arm were deemed related to study drug administration by the investigators.”
One of the biggest hurdles of regulatory approval is the safety section. These results earn leronlimab exceptionally high marks with respect to safety, but should come as no surprise because over 750 HIV patients have taken the drug without any safety issues. In the coming days or weeks the company plans on following up with the efficacy part of the trial and reveals whether or not it met its primary endpoint of clinical improvement assessed on a 12 point scale. The reason for optimism that leronlimab will crush its primary endpoint lies in the huge statistical reduction in SAEs. Scott Kelly, M.D., CytoDyn’s Chief Medical Officer, commented,
“We believe the significant reduction in SAEs in the leronlimab group ultimately translates into improved patient clinical outcomes. Prior drugs in clinical trials for the treatment of COVID-19 have resulted in an increase in SAEs in the drug treated arm versus placebo. We are extremely proud of these results.”
In a disease plagued with complications a severe reduction in the number of those complications is anecdotal evidence that the drug works. To quote Dr. Bruce Patterson of IncellDX, “anecdotes don’t come off of life support.”
Remdesivir vs Leronlimab
Leronlimab’s safety data shows a statistically significant reduction in SAEs of 32% between the active and placebo arm. In most clinical trials a reduction of 30% or more represents an approvable endpoint. Drilling down on the data we uncover that none of the SAEs were due to leronlimab, and that there was practically speaking a 100% reduction in SAEs. Remdesivir’s SIMPLE trial didn’t have a control arm, but it’s worth noting that the standard of care had a lower number of SAE’s than the active arm with remdesivir. What accounts for this anomaly is that remdesivir has 23% SAE’s (e.g. multiple organ dysfunction syndrome, septic shock, acute kidney injury, hypotension) in the patients that take it. Remdesivir is not a drug you want to give prophylactically. In layman’s terms the remdesivir cure could be worse than the disease, albeit not by much.
Fauci called remdesivir “the standard of care” and if we hold Fauci to his word then a 32% reduction in the SAEs is an approvable drug. With respect to efficacy leronlimab must beat a median recovery time of 11 days. Anecdotal results from the UCLA study on critical patients showed that the average time of hospitalization was 5 days. The anecdotal data using a patient population more severe shows that leronlimab could really make a dent in the length of hospital stays. In fact, leronlimab could turn the tide in this war against COVID-19. If the FDA sees fit to approve a very safe drug on the verge of HIV approval then the world will have a drug that arrests the disease progression, prevents people from dying, gets people out of the hospital, and could eventually turn this economy around.
The next readout is in the CD12 trial for severe COVID-19 patients. CytoDyn has requested the Drug Safety Monitoring Committee to review the progress. If these mild to moderate results translate to the severe group there is a very real chance that they will pull a “Fauci” and deem it unethical to continue with the placebo arm. In the severe group mortality is being measured, and if the placebo group closely resembles the SOC there will be deaths. The number of deaths in the control arm will be compared to the number of deaths in the active drug arm.
It seems abundantly clear there is a statistically significant reduction in SAEs in the mild to moderate group. Assuming there is also a significant reduction in SAEs in the severe group there will be a corresponding reduction of death in the active arm. It’s important to highlight that SAEs in the severe group are more likely to translate into death so lowering the number of SAEs is tantamount to lowering the death rate. Based on this logic investors should be prepared for an FDA decision on approval, Breakthrough Therapy Designation (BTD), or a Special Protocol Assessment (SPA) leading to approval.
It’s very clear from these trial results that leronlimab is on the pathway to expedited FDA approval. Within weeks it’s possible if not probable that leronlimab will be the first drug approved in COVID-19. The worldwide pandemic has necessitated the development of a treatment for COVID-19 while the race for vaccine candidates continues as Moderna (NASDAQ: MRNA), Pfizer (NYSE: PFE), and AstraZeneca (NYSE: AZN) jockey for position. Leronlimab has the ability to get people out of the hospital. It is a simple subcutaneous shot that is very easily administered. Overall it’s a game-changer in the war against COVID-19, and is a much more viable treatment than remdesivir. After the STAT News report, $10 billion of market cap flowed into GILD on news that they had a viable therapeutic. Using this same benchmark for valuation it is anticipated that CYDY will gravitate to the $25 price target as the market anticipates approval. CYDY is not a one trick pony and has a platform technology that would likely expand indications in HIV, cancer, NASH, Multiple Sclerosis, Alzheimer’s, and other immunological diseases. Many of these indications overlap GILD’s current pipeline, perplexing many CYDY shareholders who thought GILD was going to purchase CYDY. It seems clear that CYDY has intentions to develop its own pipeline, forge licensing deals, pursue a NASDAQ listing in the coming weeks, and compete head to head against GILD starting with remdesivir.
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