CytoDyn Inc (OTCQB:CYDY) said it has filed a second clinical trial protocol with the US Food and Drug Administration (FDA), this time to treat severely ill coronavirus (COVID-19) patients with its drug leronlimab.
The trial will be conducted under the same FDA-approved Investigational New Drug application that the company used to recently launch a Phase 2 trial of patients with mild-to-moderate symptoms.
The plan is to enroll patients in both protocols as quickly as possible. Severely ill patients will receive leronlimab for two weeks, with the primary endpoint of the study being the 14-day mortality rate.
READ: CytoDyn’s Phase 2 trial to treat mild-to-moderately ill coronavirus patients with leronlimab cleared by the FDA
Once a coronavirus patient needs a ventilator, the mortality rate becomes very high, CEO Nader Pourhassan noted in a statement. Leronlimab is designed to help by treating the respiratory symptoms caused by the virus.
“Once again, the FDA continues to be very supportive of everyone’s efforts to increase access to leronlimab in order to assess its therapeutic benefits for a broader range of COVID-19 patients,” Pourhassan said.
"With a study in China indicating the mortality rate among COVID-19 patients requiring mechanical ventilators at more than 85%, the world desperately needs a therapy that can help this patient population.”
The company has already administered leronlimab to 10 severely ill patients at a medical facility in New York, separate from the coming trial.
An evaluation from diagnostics company IncellDx of the first four of those patients noted “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.”
A cytokine storm occurs when the body overproduces immune cells and their activating compounds, known as cytokines. The overproduction can cause inflammation in the lungs and fluid build-up, which can lead to respiratory issues and be contaminated by a secondary bacterial pneumonia, according to The Scripps Research Institute.
In addition to its use as a potential coronavirus treatment, leronlimab has other therapeutic indications as a treatment for HIV and certain breast cancers.
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