Rocklin supplement company IGH Naturals Inc. has received a preliminary approval for its patent application for a nutritional food that the company says improves clinical outcomes for people with kidney disease.
The new patent, IGH's fourth, is for the use of synthesized oligosaccharides to improve outcomes for chronic kidney disease patients.
"Patients with kidney disease suffer from many complications that are directly linked to gut health and inflammation, but specific therapies to reduce inflammation are either highly toxic or ineffective in kidney diseases, particularly in patients on dialysis," said IGH founder and CEO Dr. Sourabh Kharait, in a news release.
The company will use the newly patented products to design medical foods to reduce inflammation for early-stage kidney disease patients as well as patients on dialysis, said Rich Foreman, chief operating officer with IGH Naturals.
The company is looking for strategic partners to perform clinical trials.
IGH's products are considered foods, as opposed to drugs. The company's synthesized oligosaccharides are designated "generally recognized as safe," or GRAS, for oral consumption by the Food and Drug Administration, Foreman said.
Kharait launched the company in 2017 to provide hydration and supplements to medical patients without using an intravenous drip. In addition to being a medical doctor, Kharait also has a doctorate in cellular and molecular pathology.
The company's first product, Humolyte, is for patients with a vulnerable gut who need hydration because of diarrhea, nausea or vomiting. The company got a patent for Humolyte in 2021.
IGH also developed a hydration and anti-cramp product for athletes called Magnak, a supplement that contains magnesium, sodium and potassium, along with other compounds to make the chemicals biologically available to be absorbed by the body. Magnak is considered a supplement, so it doesn’t require FDA approval. The company has two patents on Magnak's formulation.
The work on the new patent extends IGH's work with synthesized oligosaccharides, which were first discovered in human milk.
In addition to kidney disease, the company is investigating clinical applications for its oligosaccharides for chemotherapy and alcoholism, Foreman said.
IGH got a "Notice of Allowance" from the U.S. Patent and Trademark Office, which means the patent office believes the patent is valid, and it sets a time for fees to be paid for the office to issue the patent.