Kibow enters drug development for its probiotic for kidney health

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Housed under the company’s Kibow Pharmaceuticals arm, the new development is midway through its Phase 2 clinical trials using a cohort of people with chronic kidney disease as subjects.

The underlying technology is based on three probiotic strains discovered and developed over more than two decades by the company’s founder, Natarajan Ranganathan, PhD.

Ranganathan’s innovation was to use the intestines as a sink for toxic wastes that pollute the bloodstream of patients with kidney failure.

Using the intestines as a sink for toxins

Ranganathan’s proprietary strains, designated as S.thermophilus​ (KB 19), L.acidophilus​ (KB27) and B.longum ​(KB31) feed preferentially on uremic toxins. Research done on the probiotic formulation, under the brand name Renadyl, over the years has shown that blood levels of toxins can be significantly reduced by osmosis, as the proprietary strains feed on the molecules that infiltrate the intestines.

“The concept is that when the kidney fails, toxins increase in the blood and your blood circulates throughout your body, but the greatest amount of blood flow is in your intestines,”Ranganathan said during an interview with NutraIngredients-USA in 2013. The surface area of ​​the intestine is equivalent to that of a tennis court, he said, and the idea was to use this vast capacity absorption to help absorb these toxins. Ranganathan’s first idea, which he started on more than a decade ago with an NIS grant, was to genetically modify probiotic organisms for the task, but that approach ran into technical and regulatory difficulties.

“We went back and sifted through various naturally occurring microbes and found some that can use these toxins,”Ranganathan said. “These are naturally occurring microbes and we found that some of these microbes have a greater ability to utilize uremic toxins if you grow them under exclusive conditions, or what we call uremic conditions.”

Ranganathan has presented research on the organisms at several scientific meetings on kidney disease. Now the company has embarked on an effort to develop a drug designated as US-APR2020.

The ongoing Phase 2 trial is the first of its kind to use a probiotic formulation as an add-on treatment for patients with chronic kidney disease, Ranganathan said.

“This is a key study for our enteric/intestinal dialysis technology platform, as we are evaluating the efficacy of US-APR2020 (oral capsule) in treating patients with stage 4 CKD. We believe that US-APR2020, as an add-on oral therapy, has the potential to offer a novel therapeutic oral treatment for kidney disease, which devastates the lives of more than 850 million people worldwide,”he said.

By pursuing the path of drug development, Ranganathan is following in the footsteps of other food ingredients, such as Wellmune, which started as food ingredients before raising capital for drug development.

Prebiotics, pet products

In addition to Renadyl, Kibow Biotech also markets a prebiotic formulation called Kibow Fortis, which is a proprietary combination of two different beta-glucans, inulin, XOS and arabinogalactan. The company markets the product for its ability to promote the growth of Lactobacillus and Bifidobacterium species as well as:

  • Support a healthy immune system
  • Manage healthy cholesterol levels
  • Control your weight
  • Limit cravings.

The product joins two other supplement formulas. One, called Flora, is a multi-strain probiotic formulation for general gut health. The other, a product called Azodyl, a probiotic/prebiotic product for kidney health in dogs.

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