Housed under Kibow Pharmaceuticals arm of the company, the new development is midway through its Phase 2 clinical trials using a cohort of chronic kidney disease sufferers 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 waste products that pollute the bloodstreams of kidney disease patients.
Using intestines as toxin sink
Ranganathan’s proprietary strains, designated as S.thermophilus (KB 19), L.acidophilus (KB27) and B.longum (KB31) are, preferentially feed on uremic toxins. Research done on the probiotic formulation, branded as Renadyl, over the years has shown that the blood levels of the toxins can be significantly reduced by osmosis as the proprietary strains feed on the molecules that leak into the intestines.
“The concept is when the kidney fails the toxins increase in the blood, and your blood flows all over your body, but the largest amount of blood flow is in your bowel,” Ranganathan said during an interview with NutraIngredients-USA in 2013. The bowel’s surface area is equivalent to that of a tennis court, he said, and the idea was to use that vast absorption capacity to help soak up these toxins. Ranganathan’s first idea, which he started on more than a decade ago on an NIS grant, was to genetically modify probiotic organisms for this task but that approach ran into both technical and regulatory difficulties.
“We turned around and screened various naturally occurring microbes and found some that can use these toxins,” Ranganathan said. “These are naturally occurring microbes and we found out that some of these microbes had a greater capacity to utilize the uremic toxins if you grow them under proprietary conditions, or what we call uremic conditions.”
Ranganathan has presented research on the organisms at a number of scientific meetings in 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 therapy for chronic kidney disease patients, Ranganathan said.
"This is a key study for our Enteric/Intestinal Dialysis technology platform as we assess the effectiveness of US-APR2020 (oral capsule) to treat patients with CKD stage 4. 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 over 850 million people worldwide,” he said.
In pursuing the drug development route Ranganathan is following in the footsteps of other dietary ingredients, such as Wellmune, that started as dietary ingredients before raising the capital for drug development.
Prebiotics, pet products
In addition to Renadyl, Kibow Biotech also markets a prebiotic formulation called Kibow Fortis, is a proprietary combination of two different beta glucans, inulin, XOS and arabinogalactan. The company is marketing the product for its ability to promote the growth of Lactobacillus and Bifidobacterium species as well as:
- Supporting a healthy immune system
- Managing healthy cholesterol levels
- Keeping weight in check
- Limiting hunger cravings.
The product joins two other supplement formulas. One, called Flora, is a general gut health multi-strain probiotics formulation. The other, a product called Azodyl, a probiotic/prebiotic product aimed at the renal health of dogs.