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Kibow Therapeutics Announces Completion of First Patient in Phase 2 Study of KT-301 and Enrollment in Subsequent Six Months Open-Label Trial

By May 17, 2022September 15th, 2022No Comments

Kibow Therapeutics is a phase 2 clinical-stage company focused on developing novel live biotherapeutic products (LBP) for chronic kidney disease (CKD) patients. Kibow’s first clinical product, KT-301, is in a phase 2b multi-site global clinical trial and has recruited about half of the targeted 630 CKD stage 4 subjects since October 2021 (details on NCT04913272). The first six-month is a double-blind, randomized, placebo-controlled trial (RCT) to evaluate the safety and efficacy of KT-301, with the primary endpoint of arresting the decline of eGFR by 40% from baseline, as per ASN/NKF and US FDA Guidelines in the group treated with KT-301 as compared to the placebo group. All subjects who have completed RCT would be followed in a six-month open-label rollover study to investigate the additional safety and efficacy of KT-301. KT-301 intends to restore the gut microbiome by metabolizing and removing several uremic toxins in the bowel, thus improving the quality of life (QoL) and achieving better outcomes among CKD patients.

Generally, probiotics and prebiotics are well-known and accepted for digestive health, gut function, and immune system health benefits. However, Kibow Biotech Inc has already dedicated 24 years of R&D in synbiotic (prebiotics and probiotics) formulation for gut and beyond to all stages of CKD applications. The Company’s vision is to target the unmet medical needs of CKD patients globally. Its mission is to address kidney health by modulating the gut microbiome with unique selected proprietary probiotic strains. “The world’s first US FDA/IND approved large-scale clinical trial for an add-on probiotics therapy targeting CKD is underway, further advancing our clinical milestones,” said Dr. Natarajan Ranganathan, Chief Scientist and Founder of Kibow Biotech. “This is a key study for our Enteric/Intestinal Dialysis technology platform as we assess the effectiveness of KT-301 (oral capsule) to treat patients with CKD stage 4. We believe that KT-301, 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.”

The first patient who has completed 6 months of RCT has been enrolled in another 6 months of open-label rollover study since April 27, 2022. The open-label study allows Kibow to evaluate the long-term safety and benefits of the product. There has been strong interest in trial recruitment to date. Eighteen nephrology clinics are actively recruiting subjects in the USA. This clinical trial will be expanded to Argentina and India to accelerate the recruitment of additional ethnically diverse patients. The Company anticipates recruiting 630 subjects for the phase II clinical trial by August 2022. Moreover, the Company is planning to initiate another clinical trial with an LBP in chronic kidney disease patients undergoing routine hemodialysis in the USA and overseas countries.

Kidney disease is now taking center stage in awareness and its disproportionate burden on healthcare expenditure for people of color and other minorities (news: CKD moves to center stage with launch of Kidney Care Choices model). More than 50% of Kibow’s trial participants so far have been African-Americans and Latinos. Kibow aims to provide patients with better kidney care outcomes and improve their quality of life. In addition, to reduce the enormous financial burden on the US health system, treating Medicare beneficiaries with CKD costs $87.2 billion, according to 2019 CDC data. To achieve our clinical milestones, the Company is seeking collaboration/ investment of $50 million in series A/B growth capital for its pharmaceutical division.