CytoDyn Inc (OTCMKTS:CYDY) announced Monday that three more critically ill coronavirus (COVID-19) patients have been treated with the company’s drug leronlimab, bringing the number of patients treated with it to ten.
The use of leronlimab, which has other therapeutic indications as a treatment for HIV and certain breast cancers, is being administered under an emergency Investigational New Drug Application (IND) recently granted by the US Food and Drug Administration (FDA).
The new patients, like the seven before them, are being treated at a leading New York City hospital, the company said.
Leronlimab is intended to serve as a therapy for patients experiencing respiratory complications as a result of the virus.
The company said the diagnostics company IncellDx’s evaluation of test results from the first four patients showed “immunological benefits within three days” following treatment with leronlimab, and “lower level of cytokine storm, especially IL-6 and TNF-α, which were reduced significantly.”
The results of the three additional patients are expected this week, said the company.
In a statement, Jacob Lalezari, who is interim chief medical officer with CytoDyn, said the preliminary results observed in the patients who were severely ill with COVID-19 and treated with leronlimab are “encouraging.”
“Although the data set is still small, we saw fairly rapid and positive laboratory responses in all four patients treated, and in three of the four patients these laboratory results were associated with a favorable clinical outcome,” added Lalezari.
“We eagerly await the results of additional patients treated under the FDA’s emergency IND program, as well as the results of several randomized clinical trials about to start,” he added.
The first Phase 2 clinical trial that was filed on March 26 is a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of leronlimab in patients with mild to moderate documented COVID-19 illness and calls for 75 planned patients in up to 10 centers in the US. Patients enrolled in the trial are expected to have a treatment window of approximately six weeks.
The preliminary results offered hope that leronlimab may help hospitalized patients with COVID-19 recover from the pulmonary inflammation that drives mortality and the need for ventilators.
“We remain encouraged and hopeful that leronlimab will help patients from this devastating and relentless disease. We will aggressively pursue treatment for COVID-19 patients, and to explore leronlimab’s role in helping to alleviate the impending burden of supply chain and institutional capacity issues,” said CytoDyn CEO Nader Pourhassan.
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