Leronlimab is a monoclonal antibody knocking on the door of emergency use authorization (EUA) from the FDA. President Trump has scheduled a press conference today to announce “revolutionary” therapy. It must be Leronlimab, the owner of which, CytoDyn (CYDY), just presented favorable data from a double-blind, placebo-controlled study. It is the only drug to have done so. The drug has shown efficacy and safety in a population that is difficult to treat: mild to moderate patients. So while Gilead’s Remdesivir (GILD) (the only other drug with an EUA for Covid), remains controversial, there is an opening for something better and Leronlimab certainly is that.
Leronlimab has the coolest probing feature – it calms the cytokine storm. As you probably know, the Covid-19 virus is not as bad for you as your body’s immune response. This triggers a reaction that gets out of hand, especially in the lungs. The virus invades the body, infecting, injuring and killing cells. This causes infection. Injured cells cry out for help as they release cytokines. Cytokines invoke chemokines that rush to fight infection, but this causes more infection in a vicious cycle. In severe Covid disease, a “cytokine storm” occurs in the lungs, causing acute respiratory distress syndrome. Leronlimab calms the cytokine storm and it does it in three days. It turned out to be a lifeline. If approved, it will also save the economy.
Leronlimab is an injectable – a subcutaneous vaccine, like insulin – which means it can be given on an outpatient basis, without hospitalization. In the trial, it kept mild to moderate patients from getting worse, dramatically speeding up their healing time. In addition, the supply is sufficient to meet current demand. Gilead’s Remdesivir has unsavory side effects, nebulous efficacy, and requires IV and hospitalization. Its side effects alone are enough to prevent wide use.
CytoDyn is an underdog, rarely mentioned in the press, as the government acts like a kid in a horror movie throwing billions of dollars at politically linked drug companies. A binge eating has developed as ‘promising’ vaccines and treatments vie for government and investor attention. In May, Moderna (MRNA) issued a press release announcing the partial and unsubstantiated results of a trial that sparked the headline and insider sales soaring. Gilead has eight paid consultants on the science advisory board assembled to help the government shape a Covid response.
Meanwhile, the obscure, OTC-listed CytoDyn has a dramatic immediate future as it expects an FDA decision on emergency use authorization overnight. Trump foreshadowed today’s presser describing therapy like Leronlimab (an anti-HIV drug given by injection with results within three days). Largest fringe OTC company, CytoDyn, hopes to ‘climb’ on the Nasdaq
Hope this happens. Leronlimab is working and we need it now.
Full Disclosure: I own CYDY.