Todos Medical (TOMDF:OTCQB) announced positive interim data for its antiviral 3CL protease inhibitor Tollovir in its Phase 2 clinical trial for the treatment of critically hospitalized COVID-19 patients.
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The drug met the study's primary goal of reducing time to clinical improvement and also met several other key goals, including reducing the overall number of COVID-19 deaths, Todos Medical and joint venture partner NLC Pharma Ltd. said.
Because of the positive data, Todos Medical has formally closed the Phase 2 trial. Tollovir will now also be permitted on a compassionate use basis at Shaare Zedek Medical Center in Jerusalem.
“The recent emergence of the Omicron variant has been pushing healthcare systems to the brink of collapse,” said Dr. Dorit Arad, founder and chief technology officer of NLC Pharma. “Tollovir could be an incredibly powerful tool to reduce death and stabilize patients faster, thereby reducing their recovery time from this debilitating disease. Tollovir will help flatten the curve by freeing up hospital capacity to see more patients and perform other more routine non-COVID related hospital treatments.”
Todos Medical President and Chief Executive Officer Gerald E. Commissiong said the companies were in the process of fine tuning clinical study protocols for additional studies needed for emergency use.
“We have already begun preparing manufacturing for commercial quantities of Tollovir so that we will be able to deliver shipments in jurisdictions where we expect to be granted accelerated Emergency Use Authorization (EUA),” Commissiong said. "Our goal is to immediately target EUA in jurisdictions that will require limited additional clinical data.”
Tollovir is also being developed for the treatment of pediatric COVID-19 hospitalizations, moderate to severe adult outpatient COVID-19, moderate to severe pediatric outpatient COVID-19, adult Long COVID, and pediatric Long COVID, Commissiong said.
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