Clene Inc. announced that its wholly-owned subsidiary Clene Nanomedicine Inc. was issued a Notice of Allowance from the U.S. Patent and Trademark Office for its invention for using its patented clean-surfaced gold nanocrystals for treating patients with multiple sclerosis. Clene notes that its previously patented gold nanocrystals have surfaces that are substantially free from organic impurities and are therefore clean relative to surfaces of gold nanoparticles made by other processes. The allowed application discloses that these gold nanocrystals can be suspended in water and can be taken orally, for example, by a person with MS. MS affects an estimated 1 million people in the U.S. and 2.5 million worldwide, with a treatment market valued at $23 billion globally. New data is expected from Clene’s REPAIR-MS Phase 2 study of CNM-Au8 in the second half of 2021. Prior interim results from this study showed CNM-Au8 was associated with improvements across key central nervous system bioenergetic metabolites. Clene’s VISIONARY-MS Phase 2 study is evaluating the efficacy and safety of CNM-Au8 as a remyelinating and neuro-reparative treatment in stable relapsing MS patients with chronic visual impairment. Interim data from the Phase 2 VISIONARY-MS trial demonstrated notable, exposure-related median improvements in the primary endpoint. Completion of enrollment is expected by the end of 2021. Clene’s worldwide patent portfolio in the new field of clean-surfaced nanocrystal therapeutics includes over 100 patents issued and allowed, with around 30 more pending. The issued patents cover state of matter claims for suspensions and solutions, as well as processes for making the materials, devices for conducting the unique electro-crystal chemistry processes, and methods of using the novel materials, such as in this instance of using clean-surfaced gold nanocrystals for treating patients with MS.