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Todos Medical Provides Update on COVID-19 Oral Antiviral 3CL Protease (Main Protease) Inhibitor Tollovir Clinical Development Program in Light of Molnupiravir Clinical Trial Data from Merck
Todos Medical Provides Update on COVID-19 Oral Antiviral 3CL Protease (Main Protease) Inhibitor Tollovir Clinical Development Program in Light of Molnupiravir Clinical Trial Data from Merck.
About this update from Todos Medical Ltd.
[{"type":"text","content":"\n New York, NY, and Tel Aviv, ISRAEL, Oct. 04, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire -- Todos Medical, Ltd. (“Todos Medical”) (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, today provided an update on its COVID-19 oral antiviral 3CL protease (“Main Protease”, or “Mpro”) inhibitor Tollovir® clinical development program currently enrolling a Phase 2 clinical trial in hospitalized patients at Shaare Zedek Medical Center in Jerusalem, Israel. In light of the Data Safety Monitoring Board (DSMB) overseeing Merck’s trial in consultation with the US Food & Drug Administration (FDA) stopping enrollment after an interim analysis of 775 patient revealed a 50% reduction in the risk of hospitalization and death in unvaccinated outpatient COVID-19 patients recruited into Merck’s Phase 3 clinical trial within 5 days of symptom onset, Todos has now begun a thorough re-evaluation of outpatient trial designs to provide the fastest path to bring Tollovir to market in the outpatient setting given the now significantly lower than expected patient enrollment threshold required to demonstrate efficacy. There are currently 27 patients enrolled in the 77-patient Tollovir hospitalized clinical trial in Israel.  A pre-specified interim analysis of the safety and efficacy data of Tollovir is scheduled at 33 patients, which the Company expects to enroll in the next several weeks. Upon enrollment completion of the course of treatment for the 33rd patient, the Tollovir DSMB will convene to review the data and decide whether continued enrollment in the clinical study is warranted. Additional clinical trial sites that currently have higher volumes of COVID patients in Israel are expected to be added to the study in order to accelerate enrollment. Tollovir is a proprietary formulation of key plant extracts that contain potent, highly selective, natural 3CL protease (Mpro) inhibitor & anti-cytokine activities that make Tollovir a strong therapeutic candidate for the treatment of COVID-19. The ingredients contained within Tollovir have been deemed safe for widespread use by multiple regulatory agencies worldwide, including the US FDA, and have been used in over 5,000 human subjects since the beginning of the COVID-19 pandemic, with certain case stud...