Blood samples fromdays 0, 3, and 7demonstrated that leronlimab induced significant reductions in the cytokine storm among all 7 severely ill patients with coronavirus disease 2019 (COVID-19) under evaluation in the phase IIb/III study. The blood samples confirmed immunological benefit at day 3 and 7 in all patients, according to a press release from CytoDyn, Inc.1
“The day 7 results from these patients demonstrates even more dramatic immune restoration especially in the CD8 T-lymphocyte population, the major immune cell responsible for eliminating virally infected cells,” Bruce Patterson, MD, chief executive office, founder, IncellDx, stated in a press release. “In addition, there is a further dramatic reduction in the critical cytokine storm cytokines IL-6, TNF-alpha.”
On March 31, 2020, the FDA provided clearance for theimmediate enrollment and initiation of the phase II trial evaluating leronlimab in patients with COVID-19and mild to moderate respiratory complications, according to a press release from CytoDyn. In addition, an emergency Investigational New Drug (IND) application, filed by CytoDyn, was cleared by the FDA to allow for immediate treatment of leronlimab to 2 patients with severe COVID-19 in New York.
CytoDyn also announced positive findings from 1 patient with severe COVID-19 who was treated with leronlimab at the Southern California Medical Center. The patient was in critical condition in the ICU and received an IL-6 blocking agent, but the patient did not show any evidence of benefit within 4 days. At the same time, the patient received either an antiretroviral agent or placebo in an unrelated clinical trial.2
Leronlimab was given to the patient under an emergency IND granted by the FDA, and within 24 hours, the patient had significant clinical improvement with leronlimab. The patient was removed from external ventilation 3 days after receiving the injection of leronlimab. These findings remain consistent with other observations of leronlimab in patients with severe COVID-19 from a leading medical center in New York City, New York.