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Pipeline

A Revolutionary Approach to Treating Kidney Disease

We are advancing kidney disease programs that address critical unmet needs.

    Preclinical
    Phase 1
 Phase 2
Phase 3

KT-301

Chronic Kidney Disease (CKD)
Stage 4

Phase 2 Underway

65%

KT-301

End-Stage Renal Disease (ESRD)
Undergoing Dialysis

Phase 2-Ready

50%

Undisclosed

Potential Expansion Indications

Preclinical

20%

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)

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.