A Revolutionary Approach to Treating Kidney Disease
We are advancing kidney disease programs that address critical unmet needs.
Phase 2 Underway
Potential Expansion Indications
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
- 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
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.