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
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 studies previously shared publicly. Other oral antiviral drug candidates for COVID-19, such as Merck’s Molnupiravir and Pfizer’s PF-07321332, are chemical compounds that have yet to be deemed safe for widespread human use by any regulatory agency. Given the strong safety profile of Tollovir, the Company believes it provides a compelling alternative to newly created or repurposed failed chemical drug candidates that have yet to rigorously demonstrate long-term safety.
“Together with NLC Pharma, our joint venture and co-development partner in Tollovir, we were pleasantly surprised with the Molnupiravir DSMB’s decision to halt enrollment in Merck’s clinical study at the pre-specified interim analysis point after showing a 50% reduction in hospitalization and death based on 775 enrolled patients,” said Gerald Commissiong, President & CEO of Todos Medical. “While it is a tremendous outcome for patients with COVID-19 and the worldwide community at large to have an oral antiviral demonstrate a statistically significant reduction in the most severe outcomes of this devastating disease, it is clear to us from the data we have seen that this decision was likely driven more by the tremendous need in the market for an oral antiviral therapy than by the data itself for this mutagenesis-based drug candidate given the scarcity of available safety data available for Molnupiravir in COVID-19, and the relatively restrictive entry criteria required for its Phase 3 clinical trial.”
On September 30, 2021, Todos announced results from an observational clinical study conducted in Israel by NLC Pharma. Results from this observational study are outlined below:
Tollovir® groupObserved groupAge (range)45-8760-90Age (Mean)7573Hospitalization Days (range)6-194-41Hospitalization Days (mean)13.317.4Died in hospital05Deteriorated to respirator and recovered03High CRP serum levels at hospitalization1020CRP reduction of 50% and more within 48-72 hours5 (50%)2 (10%)
Dr. Dorit Arad, Chief Scientific Officer of NLC Pharma commented, “Our biggest hurdle in being able to finalize a full development program for Tollovir in the outpatient setting has been trying to decipher what regulators are likely to accept as an approvable endpoint with regards to safety and efficacy. Given the actions of the DSMB in stopping the trials, coupled with the positive comments heard from Dr. Fauci and Dr. Scott Gottlieb with regards to the efficacy demonstrated by Molnupiravir, we are now very comfortable that we have a comparator product against which to build our endpoints for Tollovir. We now intend to engage with regulators in India as well as in Israel, where we are currently enrolling a double blind placebo controlled Phase 2 clinical study in hospitalized patients with a pending interim data readout, to discuss how we can now finalize a pivotal outpatient trial design(s) and begin to move forward rapidly with enrollment as we also prepare for a pre-IND meeting with US FDA that will be followed by a well-defined US clinical development program.”
https://investor.todosmedical.com/news-events...-antiviral
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 studies previously shared publicly. Other oral antiviral drug candidates for COVID-19, such as Merck’s Molnupiravir and Pfizer’s PF-07321332, are chemical compounds that have yet to be deemed safe for widespread human use by any regulatory agency. Given the strong safety profile of Tollovir, the Company believes it provides a compelling alternative to newly created or repurposed failed chemical drug candidates that have yet to rigorously demonstrate long-term safety.
“Together with NLC Pharma, our joint venture and co-development partner in Tollovir, we were pleasantly surprised with the Molnupiravir DSMB’s decision to halt enrollment in Merck’s clinical study at the pre-specified interim analysis point after showing a 50% reduction in hospitalization and death based on 775 enrolled patients,” said Gerald Commissiong, President & CEO of Todos Medical. “While it is a tremendous outcome for patients with COVID-19 and the worldwide community at large to have an oral antiviral demonstrate a statistically significant reduction in the most severe outcomes of this devastating disease, it is clear to us from the data we have seen that this decision was likely driven more by the tremendous need in the market for an oral antiviral therapy than by the data itself for this mutagenesis-based drug candidate given the scarcity of available safety data available for Molnupiravir in COVID-19, and the relatively restrictive entry criteria required for its Phase 3 clinical trial.”
On September 30, 2021, Todos announced results from an observational clinical study conducted in Israel by NLC Pharma. Results from this observational study are outlined below:
Tollovir® groupObserved groupAge (range)45-8760-90Age (Mean)7573Hospitalization Days (range)6-194-41Hospitalization Days (mean)13.317.4Died in hospital05Deteriorated to respirator and recovered03High CRP serum levels at hospitalization1020CRP reduction of 50% and more within 48-72 hours5 (50%)2 (10%)
Dr. Dorit Arad, Chief Scientific Officer of NLC Pharma commented, “Our biggest hurdle in being able to finalize a full development program for Tollovir in the outpatient setting has been trying to decipher what regulators are likely to accept as an approvable endpoint with regards to safety and efficacy. Given the actions of the DSMB in stopping the trials, coupled with the positive comments heard from Dr. Fauci and Dr. Scott Gottlieb with regards to the efficacy demonstrated by Molnupiravir, we are now very comfortable that we have a comparator product against which to build our endpoints for Tollovir. We now intend to engage with regulators in India as well as in Israel, where we are currently enrolling a double blind placebo controlled Phase 2 clinical study in hospitalized patients with a pending interim data readout, to discuss how we can now finalize a pivotal outpatient trial design(s) and begin to move forward rapidly with enrollment as we also prepare for a pre-IND meeting with US FDA that will be followed by a well-defined US clinical development program.”
https://investor.todosmedical.com/news-events...-antiviral
