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The COVID-19 Opportunity
The company is now looking to enroll patients in two Leronlimab clinical trials, including a phase II trial for patients with mild to moderate COVID-19 and a phase IIb/III trial for severely and critically ill patients with COVID-19. The phase IIb/III clinical trial will have 390 patients, which will be randomized 2:1 for Leronlimab or placebo. The primary endpoint is mortality rate at 28 days. Its interim analysis will include data from 50 patients.

If one of these trials shows that Leronlimab is able to improve mortality outcomes, we can expect CYDY to experience an increase in attention from the market. This attention would only multiply if we see Leronlimab have a positive impact in both moderate and severe cases. This would be the opportunity for CytoDyn to grab the attention of the world who is looking for a safe and effective treatment for all COVID-19 patients.

Perhaps the biggest opportunity comes from the potential for Leronlimab to outperform some of the more well-known COVID-19 therapeutics. Gilead's (GILD) Remdesivir showed that 68% of the patient experienced clinical improvement, which means nearly one-third of patients failed to show improvement. What is more, there was a 13% mortality rate. In addition, the rate of adverse events was high and the therapy requires a 10-day course of intravenous administration for 30-60 minutes per dose. Admittedly, we cannot directly compare Leronlimab with Remdesivir for several reasons. Most notably, Remdesivir is an antiviral and is working to reduce viral load, whereas Leronlimab is attempting to reduce the deadly cytokine storm. However, if Leronlimab's mortality numbers outperform Remdesivir's, we should see Leronlimab start to be mentioned along with other lead candidates for COVID-19.

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