JINAN, China and PRINCETON NJ, USA, January 11, 2017 – – KBP BioSciences Co., Ltd. (“KBP” or the “Company”), a clinical stage biotechnology company dedicated to research, development, and commercialization of innovative medicines for the global market, today announced that it has concluded a positive Type B Meeting with the U.S. Food and Drug Administration (FDA) discussing the indication and clinical development plan of KBP-5074, a novel Mineralocorticoid Receptor Antagonist (MRA).
Realizing the tremendous unmet medical need of hypertension and chronic kidney disease for KBP-5074, FDA has agreed in principle with the proposed initial indication and agreed with KBP’s clinical development plan supporting a potential U.S. New Drug Application (NDA).Moreover, FDA stated that they are committed to meeting with KBP as needed to facilitate the development of KBP-5074 for the treatment of this disease.
“We are extremely pleased with the outcome of this important early interaction with FDA. The Agency’s commitment to collaborate with us as needed to facilitate the clinical development of KBP-5074underscores the significant unmet medical need of patients with uncontrolled hypertension and advanced chronic kidney disease,” commented Dr. Fred Yang, Chief Development Officer. “We believe that KBP-5074 will address this unmet medical need and potentially provide transformative clinical benefits to these patients.”
KBP-5074 is a non-steroidal MRA discovered and developed by KBP. To date, KBP has completed two Phase 1/2a studies which have elucidated the PK profile of KBP-5074 in healthy volunteers and in patients with mild to moderate CKD, and have provided preliminary data which contribute to the selection of dose levels for further clinical development.
About KBP BioSciences Co., Ltd.
KBP BioSciences Co., Ltd. is a clinical stage biotechnology company dedicated to research, development, and commercialization of innovative medicines for the global market. KBP has developed a deep pipeline focused on meeting unmet medical needs globally. The company devotes its resources to three therapeutic areas, including inflammation & autoimmune diseases organ protection, and antibiotics. KBP has built a proprietary R&D platform aimed at discovery and development of global first-in-class compounds. The platform consists of a compound library which is the basis of new compound discovery, a bacterium library aimed at multi-drug resistant bacteria, and an in vivo pharmacology platform for screening and testing new compounds. The company’s three clinical stage compounds are being developed under US FDA INDs. Headquartered in Jinan, China, KBP established its US affiliate in Princeton, New Jersey, which is responsible for clinical development and registration. The management team has decades of combined experience in drug development and registration and works with a world-class scientific advisory board to advance new therapies for significant unmet medical needs.
Invented in China for the world.
Company Contact (Jinan):
Ms. Yuanju Zhu
Company Contact (Princeton):
Fred Yang, Ph.D.
Chief Development Officer
+1 (267) 980-9451