May 30th, 2021
Cytodyn, a 1.3 billion dollar market capitalization pharmaceutical company based in California is poised to improve lives when help is desperately needed worldwide. Leronlimab, a monoclonial antibody therapy for Covid-19, has been shown to have statistically significant benefits for patients. In their April 2021 corporate presentation Cytodyn trial results showed patients who were given Leronlimab left the hospital sooner, 33 days for the critically ill patients, compared to 38.5 days for the placebo group (p value of 0.005) These outcomes were a result of the CD12 trial, which was focused on treating severe to critical populations.
Leronlimab is a CCR5 receptor antagonist. According to a May 2021 interview on Proactive, the CEO and CMO claimed that they were not concerned about a reduction in efficacy of Leronlimab for Covid-19 variants as, “it [Leronlimab] won’t be effected by any mutations in the spike protein.” According to Nader Pourhassan, Cytodyn’s CEO, a new opportunity to work with Macleods Pharmaceutical in India occurred recently when Macleaods reached out to the company. The conversations between the two firms led a cooperative agreement in order to seek “emergency use and compassionate use” authorization from the regulatory body in India for the treatment patients with Covid-19.
In a May 2021 interview with Proactive, Dr. Scott Kelly, Chief Medical Officer for Cytodyn, stated that it was an, “exciting time…the best financial position we have been in,” and “not only are physicians embracing Leronlimab but international pharmaceutical companies are embracing Cytodyn.” Dr. Kelly went on to refer to recent conversations that Cytodyn has had with stakeholders in India, Philippines, and in Europe.
On a less optimistic note, the Food and Drug Administration in the USA published a letter that sent CYDY stock reeling, falling nearly 30% on May 17th to less than $2.00 a share. The FDA has some disheartening words for shareholders in response to the CD10 and CD12 trials that had been completed for Covid patients. The CD10 trial was for mild to moderate patients, while the CD12 trial was for severe to critical patients. Cytodyn was seeking EUA for the treatment of Covid-19 with Leronlimab, but the FDA sent a clear message in their May 17th 2021 letter stating that the trial data presented was insufficient for granting an EUA at this time. In no uncertain terms the FDA wrote, “With the conclusion of both the CD10 and CD12 clinical trials, it has become clear that the data currently available do not support the clinical benefit of Leronlimab for the treatment of COVID-19.” Regarding the outcomes of the CD10 trial the FDA stated, “there was no observed effect of the drug on the study’s primary endpoint or on any of the secondary endpoints.” In relation to the CD12 trial for the severe population the FDA replied, “…also failed to find any effect of the drug on the primary study endpoint, with no difference seen in mortality (20.5% in the Leronlimab treatment group and 21.6% in the placebo treatment group); or on any of the secondary endpoints.”
At this time, it seems clear that further trial data will need to be submitted for an approval from the FDA. It also seems clear that new leads have developed with interested stakeholders in Asia and also in Brazil. Hypothetically, trials could be conducted on a shortened timeline given the large number of cases being reported in recent weeks ins India, Brazil, and the Philippines.
Great stuff I really liked the MAB would be variant independent.