Kibow Pharmaceuticals Announces Completion of First Patient in Phase II, 6 Months RCT of US-APR2020 and Enrollment in Subsequent 6 Months Open-Label Trial
NEWTOWN SQUARE, Pa., May 17, 2022 /PRNewswire/ -- Kibow Pharmaceuticals LLC is a phase 2/3 clinical-stage company focused on developing novel live biotherapeutic products (LBP) for chronic kidney disease (CKD) patients. Kibow's first clinical product, US-APR2020, 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 US-APR2020, 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 US-APR2020 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 US-APR2020. US-APR2020 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 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."
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.
About Kibow Biotech, Inc. Founded October 1, 1997, in Philadelphia, Kibow Biotech specializes in research, development, and commercialization of probiotic dietary supplements adhering to US FDA and FTC regulations. The Company's primary mission is to offer affordable, readily available, and easily administered nutritional supplements to support kidney health and other healthcare applications. Adhering to the individual countries' governmental rules and regulatory authorities, the Company's flagship product, Renadyl™, is marketed in the US and Canada, and several other countries as a kidney dietary supplement product.
Kibow's Enteric®/ Intestinal dialysis™ is based on its original concept of modulating the gut microbiome with highly specific strains of probiotics and selected functional fibers. The name Kibow, which means Hope In Japanese, originated with the vision of substituting the failing KIdney function via the BOWel in 1997 when the company was founded.
The Company's extensive scientific (R&D) and clinical data, including three pilot/observational human clinical trials, have been published in peer-reviewed scientific /medical journals (https://www.kibowbiotech.com/rd/).
About Kibow Pharmaceuticals, LLC. Kibow Pharmaceuticals, LLC., (a Delaware Limited Liability Company) is a wholly-owned subsidiary of Kibow Biotech, Inc. The pharmaceutical division was established in 2019 primarily for clinical development to evaluate the safety and efficacy of live biotherapeutic pharmaceutical products (LBP).
Forward-looking statements: This press release contains statements that reflect management's current views of future events. These statements include the status of development and transition of the currently marketed kidney health dietary supplement for its greater recognition, acceptance, and business potential as a "Live Bio-therapeutic Product (LPB)" benefits in the USA and other countries. For the present, Kibow® products are not drugs and may not be considered a treatment or a therapy. The dietary supplement formulation of Renadyl™ is not meant to cure, prevent, or mitigate any disease. Due to several factors, the proposed clinical data results as LBP results may differ significantly from the above forward-looking statements. These include, but are not limited to, the possibility that Renadyl™ may not reduce levels of uremic toxins in every individual due to differences that exist between individuals that cannot be controlled, such as genetics and lifestyle factors, as well as environmental factors that would include proper storage of the product and conditions of transport of the product in the chain of commerce. Other factors that could cause or contribute to differences in actual results include, but are not limited to: whether or not the Company or any of its collaborators will be able to fulfill human drug product regulatory requirements using the technologies of the Company; whether the cash resources of the Company will be sufficient to fund operations as planned; reliance on key employees, especially senior management; the uncertainty of the Company's future access to capital; the risk that the Company may not secure or maintain relationships with collaborators; and the Company's dependence on intellectual property. The Company expressly disclaims any intent or obligation to update these forward-looking statements except as the law requires.
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SOURCE Kibow Biotech, Inc