Pipeline
A Revolutionary Approach to Treating Kidney Disease
KT-301
KT-301 is an encapsulated consortium of proprietary strains of commensal bacteria targeting uremic toxins associated with chronic kidney disease (CKD).
KT-301 is a novel live biotherapeutic formulation designed to metabolize uremic toxins and improve gut microbiome health in CKD patients. We are investigating KT-301’s safety and its ability to halt or slow the progression of kidney disease.
Proprietary Consortium of Strains
- S. thermophilus KB19
- L. acidophilus KB27
- B. longum KB31
- B. longum XX00
+ Complementary Soluble Fibers
Drug Product
- 45 billion CFUs per capsule
- Acid-stable encapsulation
- Oral BID administration
- 24-month stability (4-8° C)
Made in the USA in a cGMP facility
Chronic Kidney Disease
Chronic kidney disease represents one of the largest costs to the U.S. healthcare system, with 2021 expenditures exceeding $130 billion. (USRDS 2021)
Chronic kidney disease (CKD) occurs when the kidneys fail to filter wastes from the bloodstream. In persons with CKD, accumulated wastes and uremic toxins (urea, uric acid, creatinine) build up, and can cause a condition known as azotemia. CKD can lead to other health problems, such as heart disease and an increased risk of stroke or heart attack. High blood pressure can be both a cause and a result of CKD.
Kidney disease is a global public health problem that affects over 800 million people worldwide. About 30 million U.S. adults have kidney disease and many are undiagnosed. CKD is the ninth leading cause of death in the U.S.
Chronic kidney disease may worsen over time and may lead to end-stage renal disease (ESRD), also known as kidney failure. Persons with ESRD require regular dialysis or a kidney transplant to maintain their health.
Stage 1
Normal to highly functioning kidney
Stage 2
Mild decrease in kidney function
Stage 3
Mild-to-moderate decrease in kidney function
Stage 4
Severe decrease in kidney function
Stage 5
Kidney failure / ESRD
Proper management of CKD can halt or slow progression of the disease. Lifestyle modifications centered around a healthy diet, physical activity, weight management, and proper sleep hygiene are widely recommended. Because diabetes and high blood pressure are the most common causes of CKD, many people with CKD take medicines prescribed to lower blood pressure, control blood glucose, and lower cholesterol. Two types of blood pressure medicines, ACE inhibitors and ARBs, have been shown to slow progression of chronic kidney disease in people with normal blood pressure and diabetes.
Kidney failure, also known as end-stage renal disease (ESRD), is characterized by an advanced state of loss of function (less than 15% of normal kidney function). When kidney function drops to this level, patients may experience symptoms from the buildup of toxins in the body. ESRD is treated by regular dialysis or kidney transplantation.
Clinical Studies
Kibow Therapeutics is committed to advancing its development programs through clinical studies and we are grateful for the volunteers with kidney disease, investigators, and medical experts who participate.
A Double-Blind, Randomized, Placebo-Controlled Phase 2 Clinical Trial to Evaluate Safety and Efficacy of KT-301 in Subjects with Chronic Kidney Disease Stage 4 (ClinicalTrial.gov Identifier: NCT04913272)
- Enrollment: ~630 patients at 23 U.S. sites
- Intervention: KT-301 (or placebo) administered orally twice daily for six months
- Primary Endpoints: Treatment emergent adverse events; halting the decline in eGFR
- Secondary Endpoints: Changes in blood uremic metabolic markers; complete blood count and hematology parameters; C-Reactive Protein (CRP) levels; improvement in Quality of Life (QOL)
Rollover Extension Clinical Trial to Evaluate the Long-Term Safety and Efficacy of KT-301 in Subjects with CKD Stage 4 Completing the KT-301-01 Study (ClinicalTrial.gov Identifier: NCT05407389)
- Enrollment: Up to 600 patients who completed six-month study of KT-301
- Intervention: KT-301 (or placebo) administered orally twice daily for six months for an additional six months
A Double-Blind, Randomized, Placebo-Controlled Phase 2 Clinical Trial to Evaluate Safety and Efficacy of KT-301 in Subjects with ESRD Undergoing Hemodialysis (Planned Study)
-
- Enrollment: 104 patients at ~10 U.S. sites
- Intervention: KT-301 administered orally at 2 capsules per day for six months (patients in placebo group will be administered placebo tablets in similar routine)
- Primary Endpoints: Treatment emergent adverse events; mean reduction in total serum indoxyl sulfate (IS)
- Secondary Endpoints: Changes in total para-cresyl sulfate (PCS) and trimethylamine N oxide (TMAO) levels; basic blood uremic metabolic markers; C-Reactive Protein (CRP) levels; Quality of Life (QOL,); Reduction in infection rates (hospital related infections); Fecal microbiome changes using 16S rRNA sequencing; Monitor Kt/urea for dialysis adequacy, frequency of hemodialysis
We Are Dedicated to Helping Patients with Chronic Kidney Disease
Kibow Therapeutics brings creative, resourceful, and well-connected life sciences industry veterans and 25 years of operating experience as a developer of live biotherapeutics across multiple domains, with a focus on kidney health.