NEW YORK & REHOVOT, Israel—Todos Medical Ltd. announced today that NLC Pharma Ltd. has added the dietary supplement NLC-001 to its joint venture with Todos Medical.
Under the terms of the agreement, Todos has been granted exclusive worldwide distribution rights for various formulations of NLC-001 (excluding Israel), as well as a right of first refusal to develop pharmaceutical drugs based on the NLC technology. Todos will be responsible for all commercial activities — including manufacturing, clinical testing, marketing and distribution — outside of Israel. NLC Pharma will commercialize NLC-001 in Israel.
NLC-001 is an orally administered proprietary blend of plant extracts that includes a powerful potential 3CL protease inhibitor. The compound has the potential to help support and maintain healthy immune function. The 3CL protease plays a vital role in the intracellular replication of coronaviruses, and 3CL protease inhibition is being evaluated as a potential therapeutic target for coronaviruses.
“In looking at the landscape for COVID-19, it is becoming clear that despite the large number of alternatives being investigated and used today, some of our best weapons may in fact be natural oral compounds that help to boost immunity or reduce excessive inflammation,” said Jorge Leon, Ph.D., chief medical and scientific Officer of Todos Medical. “Using 3CL protease inhibitors to help support immune function against coronaviruses is based on sound science. The role of a 3C protease inhibitor could be to slow or stop viral reproduction. This could support and maintain healthy immune function by giving the body time to recognize a coronavirus and mount an immune response to terminate the virus.”
“Pfizer recently announced the development of such an inhibitor as a potential pharmaceutical drug for COVID-19. NLC Pharma had worked in parallel with Agouron (later acquired by Pfizer) for many years to identify 3C inhibitors for Human rhinovirus (HRV),” Leon continued. “We believe the NLC-001 3CL protease inhibitor may ultimately prove to help support and maintain healthy immune function against various strains of coronaviruses, as it is based on a fundamental mechanism that does not change within the coronavirus family.”
NLC-001’s active ingredient is on the Israel Ministry of Health’s authorized dietary supplement import list. The U.S. Food & Drug Administration (FDA) has also granted a Certificate of Free Sale for NLC-001 to the joint venture’s U.S.-based contract manufacturer. However, NLC-001 has not received FDA approval as a prophylactic or as a therapeutic intervention for COVID-19.
Todos Medical and NLC Pharma plan to work together to meet the remaining regulatory requirements, in order to distribute branded versions of NLC-001 as a dietary supplement to help support and maintain healthy immune function in the US. NLC Pharma has filed multiple patent applications covering the NLC-001 program worldwide.
“We started developing 3C protease inhibitors in 1987 as an antiviral against HRV and since early 2000, when SARS surfaced, we have been diligently advancing both our diagnostic and therapeutic understanding of the 3C protease. At a time when others are focused on a vaccine, we are targeting the reproduction mechanism of the coronavirus. Unlike vaccine targets, this mechanism does not change even when the virus mutates,” pointed out Dorit Arad, Ph.D., president and chief scientific officer of NLC Pharma.
“A safe dietary supplement that can help support and maintain healthy immune function by slowing or stopping viral replication, giving the body’s immune system time to mount an appropriate response, is the best route to re-open economies safely and achieve the desired herd immunity,” Arad noted. “For this strategy to be effective, screening and diagnostic technologies will become more important than ever, and because of this, we believed that Todos was the right partner for this potentially game-changing dietary supplement.”
“We are extremely excited to add NLC-001 to our joint venture with NLC Pharma due to its strong safety profile, as demonstrated by being granted a Certificate of Free Sale by the FDA. Selected dietary supplements represent some of the most accessible and close-to-market alternatives to improve immune function. NLC is advancing clinical studies at hospitals in Israel to evaluate the efficacy of NLC-001 in the treatment of hospitalized COVID-19 patients,” added Gerald Commissiong, president & chief executive officer of Todos Medical. “We believe NLC-001 certainly warrants commercialization in the United States as a dietary supplement, without therapeutic claims. We are currently evaluating the best commercialization path for NLC-001.”