CytoDyn, Inc. has received emergency approval for phase two trials of its investigational drug Leronlimab
VANCOUVER — A Vancouver biotechnology company has received clearance from the U.S. Food and Drug Administration (FDA) to conduct tests of a new drug being developed to treat HIV as a potential treatment for COVID-19.
CytoDyn, Inc. has been developing Leronlimab as a potential treatment for both HIV patients and those with metastatic triple-negative breast cancer. Earlier this month they received permission to conduct testing to see if the drug might be effective in the treatment of COVID-19.
“Leronlimab binds to the CCR5 receptor inhibiting the migration of macrophages and the release of inflammatory cytokines including TNF and IL-6,” said Bruce Patterson M.D., CEO of IncellDX and advisor to CytoDyn. “This release of cytokines is what is commonly referred to as the ‘cytokine storm’ and is believed to cause profound damage in the lungs in some patients.”
Patterson said Leronlimab can also block regulatory T cells (Tregs), which can inhibit the innate immune response against pathogens, into areas of inflammation.
CytoDyn noted in a March 31 release that Leronlimab had now been used in 10 COVID-19 patients in a New York City hospital, including two who were intubated in critical condition.
“We found that patients with severe COVID-19 disease are in the midst of immunologic chaos which includes the cytokine storm,” said Patterson. “Our companion diagnostics showed that after three days of therapy, the immune profile in these patients approached normal levels and the levels of cytokines involved in the cytokine storm were much improved.”
“These preliminary results give hope that Leronlimab may help hospitalized patients with COVID-19 recover from the pulmonary inflammation that drives mortality and the need for ventilators,” added Jacob Lalezari, M.D., interim chief medical officer of CytoDyn.
The company said they have now received permission to begin phase 2 clinical trials with Leronlimab in mild-to-moderately ill COVID-19 patients. The randomized, double blind, placebo-controlled study calls for 75 patients at 10 centers across the United States. Patients enrolled in the trial are expected to have a treatment window of approximately 6 weeks.
Nader Pourhassan, Ph.D., president and chief executive officer of CytoDyn said in a statement, “The FDA has been very collaborative with our team to accelerate the opportunity to introduce a potentially beneficial treatment to so many patients affected by this horrific pandemic. We hope to complete enrollment of this trial very quickly.”
