Todos Medical Ltd said it expects patient enrollment to begin for two Phase 2/3 clinical trials for its Tollovir drug candidate in the third quarter this year after it hired Indian contract research organization (CRO) Innvocept Global Solutions to manage the studies.
It is part of Todos' joint venture with NLC Pharma and the studies will assess the oral antiviral 3CL protease inhibitor drug candidate Tollovir to treat non-hospitalized and hospitalized coronavirus (COVID-19) patients in India.
"Engaging a CRO is the first step of the regulatory process in India," said Todos in a statement, adding that Innvocept had already identified the trial sites.
"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."
Todos CEO Gerald E Commissiong added: "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 firm's 3CL protease biomarker assay, which is being developed as a more accurate measure of viral infection, load and infectiousness in COVID-19 patients.
"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 (FDA) ahead of an IND submission we are hopeful to file in the third quarter of 2021," said Commissiong.
"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."
Meanwhile, Dr Dorit Arad, the chief scientific officer (CSO) of Todos' JV partner, NLC Pharma, told investors: "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."
Todos Medical is a diagnostics and related solutions company, which has engineered solutions for the early detection of a variety of cancers. It is also developing blood tests for the early detection of neurodegenerative disorders, such as Alzheimer's disease.
It has also struck a joint venture with NLC Pharma to pursue the development of diagnostic tests targeting the 3CL protease, as well as 3CL protease inhibitors that target a fundamental reproductive mechanism of coronaviruses.
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