The Company has been actively researching and developing a Copper1 niacin product through its licensing agreement with the patent owner, Mitosynergy. Mitosynegy has been awarded multiple U.S. patents for molecular compounds for bioavailable coppers, namely Cuprous Nicotinic Acid. These patented compounds involve the only known bioavailable Copper 1 in the Copper 1 oxidative state. (For additional information, Patent Nos.: WO2016/037181 and 20150224112.)
Mitosynergy had previously received a No Objection Letter: #910, from the FDA, allowing the Copper compound to be marketed as an Initial New Dietary Ingredient ("IND"). Now the company is moving forward in the process of submitting a New Drug Application with the FDA. Copper, in its optimal oxidative state, could be used as a pharmaceutical and nutraceutical. The company is pursuing the use of Copper 1 niacin as an immune modulator to pursue a therapeutic claim for long-COVID and blood born microaerophilic spirochete bacteria pathogens, such as Lyme Disease.
Sibannac is developing its Copper1 product through its Campus Co. platform and will likely produce the initial run in the Company's Scottsdale-based, FDA registered facility.
"Sibannac will be delivering best-in-class wellness products based on cutting-edge formulations. We're working with some of the best design people in the industry and moving toward offering clinically-proven ingredients in our products," said Sibannac's CEO, David Mersky.
https://www.newsfilecorp.com/release/115526