Cytocom updates investigational new drug application for phase 2 clinical trial of CYTO-205 for treatment of COVID-19
Tuesday February 16, 2021
FORT COLLINS -- Cytocom, Inc. today provided an update regarding its CYTO-200 portfolio of clinical programs.
Cytocom said it 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 company said.
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 said it has invested in manufacturing clinical supplies of CYTO-205.
"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,” said Michael K. Handley, president and CEO of Cytocom.
“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."
In separate news, Cytocom said it has entered into an agreement with ICON plc (NASDAQ: ICLR), a global contract research organization (CRO), to manage its upcoming Phase 3 clinical trial for its lead drug candidate, CYTO-201, as a treatment for Crohn's disease.
"We are pleased with the progress we are making in our CYTO-200 clinical program, which includes Phase 3-ready assets in Crohn's disease, fibromyalgia and multiple sclerosis, as well as our COVID-19 therapy, CYTO-205," said Handley.
"CYTO-201 is the program's lead clinical asset and we are pleased to have ICON as our CRO partner given the company's proven expertise and track record of clinical excellence.
“Meanwhile, with the filing of the Phase 2 IND for CYTO-205 in COVID-19 and corresponding manufacturing, we are steadily advancing our efforts to address the significant need for COVID-19 therapies."