On Sept. 17, 2020, Todos Medical announced that NLC Pharma had added the dietary supplement NLC-001 to its joint venture with Todos Medical. NLC-001 is an orally administered proprietary blend of plant extracts that includes a powerful potential 3CL protease inhibitor that could 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.

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 is responsible for all commercial activities, including manufacturing, clinical testing, marketing and distribution outside of Israel. NLC will be responsible for the commercialization of NLC-001 in Israel. 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) granted a Certificate of Free Sale for NLC-001 to the Joint Venture’s U.S.-based contract manufacturer on August 28, 2020. NLC-001 has not received FDA approval as a prophylactic or as a therapeutic intervention for COVID-19. The companies will work together to meet the remaining regulatory requirements to distribute branded versions of NLC-001 as a dietary supplement to help support and maintain healthy immune function in the United States. NLC Pharma has filed multiple patent applications covering the NLC-001 program worldwide.