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SARS-CoV-2 was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China. The origin of SARS-CoV-2 causing the COVID-19 disease is uncertain, and the virus is highly contagious. COVID-19 typically transmits person to person through respiratory droplets, commonly resulting from coughing, sneezing, and close personal contact. Coronaviruses are a large family of viruses, some causing illness in people and others that circulate among animals. For confirmed COVID-19 infections, symptoms have included fever, cough, and shortness of breath. The symptoms of COVID-19 may appear in as few as two days or as long as 14 days after exposure. Clinical manifestations in patients have ranged from non-existent to severe and fatal. At this time, there are minimal treatment options for COVID-19.
The “cytokine storm” is believed to play an integral role in the development of acute respiratory distress syndrome (ARDS) in those affected by COVID-19. Chemokines and chemokine receptors play a critical role in the recruitment, activation, and coordination of leukocytes in the pathophysiology of lung inflammation. The acute respiratory distress syndrome (ARDS) of COVID-19 results from the accumulation of neutrophils within the pulmonary circulation and alveolar spaces. Leronlimab (PRO 140) inhibits the migration of Tregs into areas of inflammation, which can inhibit the innate immune response against pathogens and, most importantly, the migration of macrophages and release of pro-inflammatory cytokines in lungs. Leronlimab can potentially mitigate the cytokine storm.
Recent laboratory data for patients treated with leronlimab for COVID-19 infection has shown increases in the profoundly decreased CD8 T-lymphocyte percentages by Day 3, normalization of CD4/CD8 ratios, and resolving cytokine production including reduced IL-6 correlating with patient improvement. The current data suggests a trend toward the restoration of immune function by day 7. Restoration of the immune function is critical in COVID-19 patients to prevent opportunistic infections.
Leronlimab has been administered to fifteen severely ill COVID-19 patients at four hospitals, ten patients treated at a leading medical center in the New York City area, and five patients at three other hospitals. Each patient received treatment under an emergency investigational new drug (EIND), which was granted by the U.S. Food and Drug Administration (FDA) for each patient. The evaluation of leronlimab for patients with mild-moderate COVID-19 indications will be conducted under the Company’s Phase 2 randomized clinical trial. Also, CytoDyn has the approval to proceed with a Phase 2b/3 trial for 390 severely ill COVID-19 patients. This study is a double-blinded study with a 2:1 ratio (a drug to placebo ratio). Patients enrolled in this trial are expected to be administered leronlimab for two weeks, with the primary endpoint being the mortality rate at 28 days and a secondary endpoint of the mortality rate of 14 days. The Company will perform an interim analysis of the data from 50 patients following two weeks of leronlimab therapy.
The mechanism of action of leronlimab in quieting the cytokine storm and restoration of immune function is an important mechanism that has applicability across multiple disease processes. CytoDyn will be exploring these opportunities to help patients and expand the pipeline of opportunities for leronlimab.