Todos Med Ltd (TOMDF)

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Todos Medical Retains CRO for COVID-19 Outpatient and Inpatient Phase 2/3 Clinical Trials for Oral Antiviral 3CL Protease Inhibitor Tollovir

• Trials will separately enroll non-hospitalized and hospitalized patients
• Clinical trials in India targeted to be adaptive design to enable expansion into pivotal development upon achieving data milestone

New York, NY, and Tel Aviv, ISRAEL, July 28, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire-- Todos Medical, Ltd. (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, today announced it has retained the services of Innvocept Global Solutions, an Indian clinical research organization (CRO), to manage 2 adaptive design Phase 2/3 clinical trials the Company is preparing to initiate with its joint venture partner NLC Pharma of its proprietary oral antiviral 3CL protease inhibitor drug candidate Tollovir™ for the treatment of non-hospitalized and hospitalized COVID-19 patients in India. Engaging a CRO is the first step of the regulatory process in India. The Company expects enrollment for both trials to begin in the third quarter of 2021 with initial, trial expansion-enabling data expected in the fourth quarter of 2021 that could make each trial become part of the Company’s global pivotal clinical development program for Tollovir that would begin in the fourth quarter of 2021.

“We are pleased to have completed this critical step of retaining a CRO for Tollovir’s clinical development in India and are very impressed with Innvocept’s deep experience in executing rapidly enrolling FDA quality COVID-19 clinical trials with over 10 completed to date, and successfully working with US-based pharmaceutical companies to execute successful clinical trials in India,” said Gerald E. Commissiong, President & CEO of Todos Medical. “Enrollment is also starting to accelerate in our ongoing 77 patient Phase 2 randomized placebo-controlled trial of Tollovir™ at Shaare Zedek Medical Center in Jerusalem, Israel for the treatment of hospitalized COVID-19 patients. This trial opened enrollment in April 2021 and is also evaluating the use of TolloTest™ as a companion diagnostic for antiviral therapy. TolloTest is the Company’s proprietary 3CL protease biomarker assay that is being developed as a more accurate measure of viral infection, load and infectiousness in COVID-19 patients.”

Mr. Commissiong continued, “As we move forward with the clinical development of Tollovir in Israel, we felt it was critical to have a second program recruiting in a larger, less vaccinated jurisdiction that has the potential for faster recruitment. We believe this dual-track clinical development program in Israel and India will have the benefit of showing Tollovir’s clinical efficacy in hospitalized patients when compared to, or in combination with, different standards of care that are emerging internationally. We are also now heavily engaged in planning Tollovir’s US regulatory strategy and planning for a pre-IND meeting with the US Food & Drug Administration ahead of an IND submission we are hopeful to file in the third quarter of 2021. This submission will set the stage for the opening of a US IND and clinical studies intended to ultimately dovetail our global pivotal clinical development program for Tollovir. The expansion of Tollovir’s clinical development into non-hospitalized patients dramatically opens the potential market opportunity for Tollovir, as it is becoming increasingly clear that vaccinated individuals will become infected with COVID-19 in addition to the unvaccinated and those with waning immunity.”

“We continue to compile non-clinical data that includes the Delta variant and is supportive of a regulatory filing for Tollovir. The initial clinical data gathered during a 32 patient Phase 2 open-label, controlled study conducted in Israel in 2020 at the height of the pandemic showed that Tollovir had statistically significantly improved results on key clinical endpoints including death rate, intubation, and mean time to patient discharge,” said Dr. Dorit Arad, PhD, Chief Scientific Officer of NLC Pharma. “Our internal mechanism of action data indicates that Tollovir possesses both exquisitely strong 3CL protease inhibition activity and anti-cytokine activity, based on distinct molecular mechanisms present in its formulation,” Dr. Arad continued. “This dual mechanism makes Tollovir unique among the emerging class of 3CL protease inhibitors currently in development. Researchers are quickly discovering that the fast-replicating Delta variant has shown an improved ability to out-compete neutralizing antibodies for the ACE2 receptors vs. earlier versions of SARS-CoV-2. The Delta variant heightens the call for a safe and effective oral antiviral therapy that can stop an infected person’s viral load from becoming so significant that it triggers cytokine release syndrome, which can lead to hospitalization, death or Long COVID. We believe Tollovir has addressed both viral replication and cytokine storm activity.”

Todos and NLC are currently finalizing study designs for both of its planned Tollovir Phase 2/3 trials in hospitalized and non-hospitalized patients in India, and Innvocept has already identified the clinical trial sites for these important studies. The Company estimates the direct costs to reach interim data for both trials in India will be collectively be approximately $1 million.

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