Cytocom gets FDA nod for phase 2 trial of Covid drug candidate CYTO-205

Cytocom has secured clearance from the US Food and Drug Administration (FDA) to undertake a phase 2 clinical trial of CYTO-205 for the treatment of Covid-19.

The company’s investigational new drug (IND) application for the mid-stage trial has been cleared by the FDA, paving way for Cytocom to assess the safety and efficacy of CYTO-205 in slowing or halting the progression of the SARS-CoV-2 virus.

According to Cytocom, CYTO-205 is designed to modulate the function of the immune system, reduce elevated inflammatory responses related to viral infection and block viral replication in human lung cells.

The randomized phase 2 trial of CYTO-205 is anticipated to start patient enrollment during Q2 2021 at Loma Linda University Health in Loma Linda, California.

Michael Handley – President and CEO of Cytocom said: “Even as new vaccines are introduced into the market and inoculation programs continue to expand, the need for safe and effective therapies to treat COVID-19 remains undiminished, especially in light of the spread of new, highly contagious variants of the virus.

“The early data regarding the potential of CYTO-205, as both an interventional therapy and a preventative agent is compelling, and we look forward to working with investigators at Loma Linda to further explore the possibilities.”

Cytocom gets FDA nod for phase 2 trial of Covid drug candidate CYTO-205. Photo courtesy of fernando zhiminaicela from Pixabay.

The double-blind, placebo-controlled phase 2 study of CYTO-205 will enroll a maximum of 75 patients aged 18 years or more who have tested Covid positive, show symptoms of mild infection, and are at high risk for disease progression.

After getting either a placebo or CYTO-205, patients will be observed for 30 days to determine how many cases progress to a more severe stage of Covid-19.

Cytocom said that preclinical in vitro studies using the 229E coronavirus strain and the SARS-CoV-2 pathological corona virus strain have shown the potential of CYTO-205 in blocking the replication of corona viruses in human lung cells.

Previously generated data also indicate that CYTO-205 can thwart the life-threatening lung inflammation resulting from Covid-19, and also reduce the risk of reinfection, said the clinical stage biopharma company.

Coronavirus, COVID-19, CYTO-205, Cytocom, Michael Handley, SARS-CoV-2 virus, US Food and Drug Administration