Cytocom has submitted an Investigational New Drug (IND) application with updated protocols to the U.S. Food and Drug Administration (FDA) to begin a Phase 2 clinical trial, to evaluate the safety and efficacy of CYTO-205 to slow or halt the progression of the SARS-CoV-2, the virus that causes COVID-19.
Preclinical in vitro studies using coronavirus strain 229E have demonstrated the potential of CYTO-205 to inhibit the replication of a coronavirus (strain 229E) in human lung cells. The trial, titled, "A Randomized, Placebo-Controlled, Phase 2 Study to Evaluate Safety and Efficacy of CYTO-205 in Adult Patients With Mild COVID-19 Infection Who Are at High Risk for Disease Progression," is expected to begin in the second quarter of 2021 upon FDA clearance of the IND. In preparation for the start of the trial, Cytocom has invested in manufacturing clinical supplies of CYTO-205.
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"Despite the recent launch of several COVID-19 vaccines, there remains a tremendous need for effective therapies for those infected with SARS-CoV-2, especially in light of the emergence of highly contagious new variants of the virus. To date, research has provided compelling rationale for the potential CYTO-205 could have as both a therapeutic intervention and as a prophylactic agent to reduce the spread of the disease, and we look forward to working with the FDA to advance the drug's development and bring a therapeutic to patients suffering from the potentially life-threatening consequences of COVID-19," Michael K. Handley, President and CEO of Cytocom, said.