PRINCETON, N.J., 11 December 2021 -- KBP Biosciences Co., Ltd. (“KBP Biosciences” or the “Company”), a clinical-stage biotechnology company dedicated to research, development, and commercialization of innovative medicines for the global market, today announced that an efficacy subgroup analysis of KBP-5074 results from the Phase 2 BLOCK-CKD study was presented at the Global CardioVascular Clinical Trialist Forum (CVCT) 2021 held December 2-5, 2021. The clinical results of KBP-5074 Phase 2 BLOCK-CKD study was released in 2020. The title of the poster presentation was “Efficacy Subgroup Analysis: KBP-5074, a Non-Steroidal, Highly Selective, Mineralocorticoid Receptor Antagonist (MRA) for the Treatment of Uncontrolled Hypertension in CKD Stage 3b/4” with James McCabe MD, KBP’s Senior Vice President of Clinical Development and Medical Affairs as lead author.
In general, subgroup analysis shows that KBP-5074 demonstrated significant systolic blood pressure reduction (placebo subtracted) ranging from -5.3 to -9.3 mmHg for 0.25 mg and -7.6 to -14.9 mmHg for 0.5 mg across multiple subgroups including age categories, baseline eGFR, baseline SBP, baseline antihypertensive medications, gender, albuminuria, ethnicity, and diabetic status. The results are consistent with the overall BP reduction effect in the BLOCK-CKD study in which clinically meaningful and statistical significant systolic blood pressure reduction (placebo subtracted) of −7.0 (3.37) mmHg for KBP-5074 0.25 mg (P=0.0399) and −10.2 (3.32) mmHg for KBP-5074 0.5 mg (P=0.0026) were observed.
(Photo: KBP Biosciences Lab)
“Many patients with stage 3b/4 CKD are at their maximum tolerated dose of anti-hypertensive medications and still have uncontrolled or resistant hypertension. Data from the BLOCK-CKD subgroup analysis demonstrate robust BP-lowering efficacy across different populations. The BP reduction with KBP-5074 is especially evident among patients with stage 4 CKD, and patients with type 2 diabetes and resistant hypertension. According to literatures and reports, the related mortality and cardiovascular emergencies could be reduced by up to 40% to 60% with every 10 mmHg blood pressure reduction,” said Fred Yang, Chief Development Officer of KBP.
(Photo: KBP Biosciences Lab)
“The robustness of the results of the BLOCK-CKD study is exemplified by this analysis and provides a compelling rationale for the use of KBP-5074 for the treatment of patients with CKD,” said Dr. George Bakris, MD, Director of the American Heart Association’s Comprehensive Hypertension Center at the University of Chicago Medical and co-lead investigator on the BLOCK-CKD clinical trial.
“This subgroup analysis adds confidence in the ability of KBP-5074 to provide consistent and clinically significant blood pressure control in patients who have failed on multiple anti-hypertensive medications as the level of BP is an important risk factor for stroke and myocardial infarction especially among those with diabetes,” said Dr. Bertram Pitt, MD, Professor Emeritus, University of Michigan Medical School and co-lead investigator of the BLOCK-CKD clinical trial.
Relevant Link: http://kbpbio.com/publish/2021CVCTPoster-EfficacySubgroupAnalysisofKBP5074-2-001.pdf
About The Global CardioVascular Clinical Trialists Workshop (CVCT)
The Global CardioVascular Clinical Trialists Workshop is a high-level, private meeting with an exceptional expert faculty, endorsed/supported by Inserm, NHLBI, ESC Working Group on CV Pharmacology and Drug Therapy, FDA, EMEA and Duke Heart Center. CVCT Workshops have become the authoritative meeting place for cardiovascular trial principal investigators, statisticians, Pharma R&D experts and regulators from the major transatlantic agencies. Brainstorming topics include CV drugs, device and biomarker development and trial design, conduct, ethics, interpretation, approvability and implementation. CVCT Workshop involves a limited number of participants and includes distinguished cardiologists, clinical trialists, principal investigators and statisticians from academia as well as senior R&D pharma doctors and NIH, EMEA-CPMP and FDA doctors.
About KBP Biosciences
KBP Biosciences is a global, clinical-stage biotech company focused on research and development of new chemical entities with known mechanisms of action targeting underserved patient populations. Headquartered in Princeton, NJ, KBP Biosciences has strong capabilities from discovery and CMC through global clinical development and registration. The company principally devotes its resources in three therapeutic areas: major organ protection, anti-infectives and respiratory inflammation.
KBP has built a proprietary R&D platform aimed at the discovery and development of global first-in-class compounds. The platform includes a compound library as basis of new compound discovery, a library of multi-drug resistant bacteria, and an in vivo pharmacology platform for screening and testing new compounds. KBP Biosciences is actively seeking to identify additional promising therapeutic opportunities and further develop its product portfolio.
About KBP-5074
KBP-5074 is a non-steroidal MRA discovered and developed by KBP Biosciences. KBP-5074 selectively binds to recombinant human MRs with much higher affinity than to recombinant human glucocorticoid, progesterone, and androgen receptors, suggesting that KBP-5074 should be effective in blocking the hypertensive and renal tissue damaging effects of aldosterone with reduced risk of pro-diabetic and adverse endocrine effects. KBP-5074 has been investigated in 9 clinical studies including the BLOCK-CKD Phase 2b study. The Phase 3 study has been started in close consultation with the division of Cardiology and Nephrology of FDA.
About Advanced CKD and Uncontrolled Hypertension
In the US alone, uncontrolled hypertension and stage 3b and 4 CKD afflict more than 3 million patients in whom currently available MRAs are either contraindicated or must be used with extreme caution due to the risk of hyperkalemia. Treatments that lower blood pressure are available and include ACE-Is, ARBs, and diuretics among others. Many patients with stage 3b/4 CKD are at their maximum tolerated dose and still have uncontrolled or resistant hypertension. Available MRAs can provide additional blood pressure control in some of these patients, but usually will increased risk of hyperkalemia.
For more information about KBP Biosciences, please visit the company website at https://www.kbpbiosciences.com/.
Contacts:
Investor Relations:
ir@kbpbiosciences.com
Public Relations:
pr@kbpbiosciences.com
PRINCETON, N.J., 6 August, 2021 -- KBP Biosciences Co., Ltd. (“KBP Biosciences” or the “Company”), a clinical-stage biotechnology company dedicated to research, development, and commercialization of innovative medicines for the global market, today announced publication of “The Non-Steroidal Mineralocorticoid Receptor Antagonist KBP 5074 Limits Albuminuria and has Improved Therapeutic Index Compared With Eplerenone in a Rat Model With Mineralocorticoid-Induced Renal Injury” in the peer-reviewed journal, Frontiers in Pharmacology. The paper was published in the June 2021 issue (DOI: 10.3389/fphar.2021.604928) with Professor Frederic Jaisser, as the lead author.
A uninephrectomized Sprague Dawley rat model of aldosterone-mediated renal disease was used to evaluate the therapeutic indices (TIs) and efficacy of the non-steroidal mineralocorticoid receptor antagonist (MRA) KBP-5074 and steroidal MRA eplerenone. The TI was calculated for each drug as the ratio of the concentration of drug producing 50% of maximum effect (EC50) for serum K+ to the EC50 for UACR. The TIs were 24.5 for KBP-5074 and 0.620 for eplerenone, resulting in a 39-fold improved TI for KBP-5074 compared with eplerenone. Additionally, the urinary Na+ and Na+/K+ ratio significantly increased at the middle and high doses of KBP-5074, but only at the highest dose of eplerenone. These results showed an increased TI and efficacy of KBP-5074 compared with eplerenone over a wider therapeutic window.
“The steroidal MRAs have been shown to be effective in reducing CV mortality and hospitalizations for heart failure in patients with heart failure and a reduced left ventricular ejection fraction as well as reducing blood pressure and albuminuria in patients with hypertension and / or chronic kidney disease (CKD). The study by Jaisser et al. shows that the new non-steroidal MRA KBP-5074 has an increased therapeutic index and efficacy over a wide dose range as compared to the steroidal MRA eplerenone in a renal impairment model. These results suggest that KBP-5074 has the potential to provide an even greater benefit to patients with advanced CKD than the steroidal MRAs,” said Dr. Bertram Pitt, M.D., Professor Emeritus, University of Michigan Medical School.
“This study demonstrates that the novel non-steroidal MRA KBP-5074 is more efficacious in reducing UACR than steroidal MRA eplerenone and increases therapeutic index in a chronic kidney disease rat model. These findings are consistent with the clinical results from the BLOCK-CKD study which showed KBP-5074 is an efficacious and safe treatment for CKD patients,” said Jay Zhang, Ph.D., Vice President of Discovery for KBP Biosciences and co-author of the manuscript.
Link to the publication in Frontiers in Pharmacology:
https://doi.org/10.3389/fphar.2021.604928
About KBP Biosciences
KBP Biosciences is a global, clinical-stage biotechnology company focused on discovering, developing, and commercializing innovative small-molecule therapeutics for the treatment of serious cardiorenal and infectious diseases with large unmet needs. Headquartered in Princeton, NJ, KBP Biosciences principally devotes its resources to major organ protection and anti-infectives therapeutic areas.
KBP Biosciences’ lead product candidate, KBP-5074, is a potentially best-in-class, next-generation, non-steroidal Mineralocorticoid Receptor Antagonist (MRA) discovered and developed by KBP’s scientists, and is being developed globally to initially treat Stage 3b/4, or moderate-to-severe, Chronic Kidney Disease (CKD) patients with uncontrolled hypertension. KBP Biosciences’ second product candidate, KBP-7072, a potentially best-in-class, potent, broad spectrum aminomethylcycline, is being developed as an anti-infective for Gram-positive, Gram-negative and anaerobic bacteria, including multi-drug resistant pathogens.
KBP Biosciences has built a proprietary small-molecule drug discovery platform to advance its pipeline of product candidates. The platform includes state-of-the-art processes for novel drug compound identification, high-volume screening and optimization, along with its substantial library of diverse chemical entities and select potential compounds. With its discovery platform, KBP Biosciences is able to generate a multitude of drug compounds and quickly identify the most promising differentiated and potent product candidates.
About KBP-5074
KBP-5074 is a non-steroidal MRA discovered and developed by KBP Biosciences. KBP-5074 selectively binds to recombinant human MRs with much higher affinity than to recombinant human glucocorticoid, progesterone, and androgen receptors, suggesting that KBP-5074 should be effective in blocking the hypertensive and renal tissue damaging effects of aldosterone with reduced risk of pro-diabetic and adverse endocrine effects. KBP-5074 has been investigated in eight phase 1 studies and the BLOCK-CKD phase 2b study. Phase 3 study preparations has been closely consulted with the FDA’s Division of Cardiology and Nephrology.
For more information about KBP Biosciences, please visit the company website at https://www.kbpbiosciences.com/.
Contacts:
Investor Relations:
ir@kbpbiosciences.com
Public Relations:
pr@kbpbiosciences.com
PRINCETON, N.J., 31 July, 2021 -- KBP Biosciences Co., Ltd. (“KBP Biosciences” or the “Company”), a clinical-stage biotechnology company dedicated to research, development, and commercialization of innovative medicines for the global market, is pleased to announce the appointment of James Fang as Chief Financial Officer of KBP Biosciences, effective on July 15, 2021.
Commenting on the appointment, Dr. Zhenhua Huang, Founder and Executive Chairman of KBP Biosciences, stated, “We are delighted to announce James's appointment as CFO. James brings more than 25 years of experience to the role. He has served a number of financial leadership positions with a proven track record of success. His extensive experience in financial industry including corporate finance, investment banking and private equity investment is essential to our future success.”
James formerly served as China CEO of Lincoln International, a global mid-market investment bank advising business owners and senior executives of leading private equity firms and public and privately held companies around the world. James used work at Morgan Stanley’s Investment Banking Division where he was an Executive Director and executed capital market transactions, including IPOs, debt and equity financings for leading Chinese companies. Throughout his career, James also held virous senior positions at Joyme Group, HIW Investment and Huaneng Capital. James received an MBA degree from Boston University and a BA degree from Sun Yat-sen University. James is a CFA charter holder.
(Photo: James Fang, Chief Financial Officer of KBP Biosciences）
About KBP Biosciences
KBP Biosciences is a global, clinical-stage biotechnology company focused on discovering, developing, and commercializing innovative small-molecule therapeutics for the treatment of serious cardiorenal and infectious diseases with large unmet needs. Headquartered in Princeton, NJ, KBP Biosciences principally devotes its resources to major organ protection and anti-infectives therapeutic areas.
KBP Biosciences’ lead product candidate, KBP-5074, is a potentially best-in-class, next-generation, non-steroidal Mineralocorticoid Receptor Antagonist (MRA) discovered and developed by KBP’s scientists, and is being developed globally to initially treat Stage 3b/4, or moderate-to-severe, Chronic Kidney Disease (CKD) patients with uncontrolled hypertension. KBP Biosciences’ second product candidate, KBP-7072, a potentially best-in-class, potent, broad spectrum aminomethylcycline, is being developed as an anti-infective for Gram-positive, Gram-negative and anaerobic bacteria, including multi-drug resistant pathogens.
KBP Biosciences has built a proprietary small-molecule drug discovery platform to advance its pipeline of product candidates. The platform includes state-of-the-art processes for novel drug compound identification, high-volume screening and optimization, along with its substantial library of diverse chemical entities and select potential compounds. With its discovery platform, KBP Biosciences is able to generate a multitude of drug compounds and quickly identify the most promising differentiated and potent product candidates.
For more information about KBP Biosciences, please visit the company website at https://www.kbpbiosciences.com/.
Contacts:
Investor Relations:
ir@kbpbiosciences.com
Public Relations:
pr@kbpbiosciences.com
PRINCETON, N.J., 31 July, 2021 -- KBP Biosciences Co., Ltd. (“KBP Biosciences” or the “Company”), a clinical-stage biotechnology company dedicated to research, development, and commercialization of innovative medicines for the global market, is pleased to announce the appointment of Dr. Julia Yang as Chief Operating Officer of KBP Biosciences.
“We are delighted to have Dr. Julia Yang as our new COO. Her experience and expertise will add value to the business,” said Dr. Zhenhua Huang, Founder and Executive Chairman of KBP Biosciences. “Julia will collaborate with our senior executives and me in setting and driving organizational vision and strategy, and leading company-wide, cross functional programs and projects, with particular focus on global clinical development, clinical operation, Discovery, Chemistry, Manufacturing and Controls (CMC).”
Julia has 24 years of pharmaceutical/medical device experiences with managerial and supervisory experiences in Global Clinical Research & Drug Development, Global Medical Affairs and Global Business Development. She has proven track records in designing and leading global clinical programs (Phase I-IV and life cycle management) across multiple therapeutic areas, leading to NDA/MAA/BLA submissions, worldwide drug approvals and successful product launches globally (Praluent® for lipid lowering /cardiovascular, Fycompa® for anti-seizure, etc.). She also has proven ability in the new assets evaluation and due diligence that lead to successful mergers and acquisitions and international partnerships. Her extensive experience gained by working at global pharmaceutical companies including Sanofi, Baxter, Medtronic, Eisai and Amgen. Julia holds MD degree and Master of Business Administration (MBA) and completed her clinical /research fellowship training at Johns Hopkins University, School of Medicine and Mayo Clinic.
About KBP Biosciences
KBP Biosciences is a global, clinical-stage biotechnology company focused on discovering, developing, and commercializing innovative small-molecule therapeutics for the treatment of serious cardiorenal and infectious diseases with large unmet needs. Headquartered in Princeton, NJ, KBP Biosciences principally devotes its resources to major organ protection and anti-infectives therapeutic areas.
KBP Biosciences’ lead product candidate, KBP-5074, is a potentially best-in-class, next-generation, non-steroidal Mineralocorticoid Receptor Antagonist (MRA) discovered and developed by KBP’s scientists, and is being developed globally to initially treat Stage 3b/4, or moderate-to-severe, Chronic Kidney Disease (CKD) patients with uncontrolled hypertension. KBP Biosciences’ second product candidate, KBP-7072, a potentially best-in-class, potent, broad spectrum aminomethylcycline, is being developed as an anti-infective for Gram-positive, Gram-negative and anaerobic bacteria, including multi-drug resistant pathogens.
KBP Biosciences has built a proprietary small-molecule drug discovery platform to advance its pipeline of product candidates. The platform includes state-of-the-art processes for novel drug compound identification, high-volume screening and optimization, along with its substantial library of diverse chemical entities and select potential compounds. With its discovery platform, KBP Biosciences is able to generate a multitude of drug compounds and quickly identify the most promising differentiated and potent product candidates.
For more information about KBP Biosciences, please visit the company website at https://www.kbpbiosciences.com/
Contacts:
Investor Relations:
ir@kbpbiosciences.com
Public Relations:
pr@kbpbiosciences.com
KBP-5074, a highly-selective non-steroidal mineralocorticoid receptor antagonist, lowered clinic systolic blood pressure (SBP) by 10.2 mm Hg with reduced hyperkalemia risk in the phase 2b study
Article published online; to be included in July 2021 print edition of Hypertension (AHA)
PRINCETON, N.J., June 16, 2021 -- KBP Biosciences, a clinical-stage biotechnology company dedicated to research, development, and commercialization of innovative medicines for the global market, today announced publication of the results of the BLOCK-CKD (Blood Pressure in Chronic Kidney Disease) phase 2b study of KBP-5074 by the peer-reviewed AHA journal, Hypertension. BLOCK-CKD achieved its primary endpoint with clinical and statistical significance: systolic blood pressure (SBP) was reduced in both 0.5 mg and 0.25 mg KBP-5074 cohorts by −10.2 mm Hg and -7.0 mm Hg, respectively, compared to placebo. There were no reports of severe hyperkalemia or acute kidney injury with either dose of KBP-5074. The trial results of the BLOCK-CKD study paper were published online and will appear in the July 2021 print edition of the journal.
“Data from the BLOCK-CKD study demonstrate substantial systolic BP-lowering efficacy in a very difficult-to-treat hypertensive population with CKD,” said Dr. William B White, M.D., a professor of medicine from the Cardiology Center at the University of Connecticut School of Medicine who was not involved with the conduct of BLOCK-CKD. “While the steroidal MRAs, such as spironolactone and eplerenone are effective in lowering BP in the CKD patients, the risk of hyperkalemia is far too great to be used routinely in clinical practice,” said Dr. William B White. “The results of the BLOCK-CKD study show the potential for KBP-5074 to be a potentially best-in-class treatment option for patients with uncontrolled hypertension and advanced CKD, a major unmet medical need in a group of patients otherwise lacking a treatment option that is both safe and effective,” said Zhenhua Huang, Ph.D., Chairman of KBP Biosciences.
“Publication of the BLOCK-CKD Phase 2b trial results in such a prestigious peer-reviewed journal highlights the potential of KBP-5074 in advancing care in this patient population. Following consultation with the FDA, we are excited to move into a global Phase 3 program this year,” added Fred Yang, Ph.D., Chief Development Officer of KBP Biosciences and co-author of the manuscript. “These results further support the safety and efficacy of KBP-5074 for treating advanced CKD patients with uncontrolled hypertension,” said Dr. George Bakris, M.D., Director of the American Heart Association’s Comprehensive Hypertension Center at the University of Chicago Medical and co-lead investigator on the clinical trial, as well as lead author of the manuscript. “This publication highlights the importance and potential of KBP-5074 as a treatment option for patients with few, if any, options for treatment. I look forward to supporting the continuing development of KBP-5074 in a pivotal phase 3 trial study,” said Dr. Bertram Pitt, M.D., Professor Emeritus, University of Michigan Medical School and co-lead investigator of the BLOCK-CKD clinical trial.
About BLOCK-CKD
BLOCK-CKD was a phase 2b, international, multicenter, randomized, double-blind, placebo-controlled, parallel-group study that evaluated the safety, efficacy, and pharmacokinetics of the non-steroidal MRA KBP-5074 for uncontrolled hypertension in patients with stage 3b/4 CKD who were receiving background antihypertensive medication. 162 patients were randomized 1:1:1 to once-daily treatment with KBP-5074 0.25 mg, KBP-5074 0.5 mg, or placebo, stratified by estimated glomerular filtration rate (eGFR, ≥30 versus <30 mL/min/1.73 m2) and SBP (≥160 versus <160 mmHg). Male and female patients aged 18 through 85 years with stage 3b/4 CKD (eGFR ≥15 and ≤44 mL/min/1.73 m2) and uncontrolled Grade 1 and 2 systolic hypertension (resting trough cuff seated SBP ≥140 and ≤179 mm Hg) were enrolled. The primary efficacy endpoint was the change in trough cuff seated SBP from baseline to Day 84 of each dose of KBP-5074 compared to placebo. Secondary endpoints included diastolic blood pressure (DBP), changes in the urinary albumin-creatinine ratio (UACR), changes in serum potassium/incidence of hyperkalemia, and changes in eGFR and serum creatinine.
Approximately 40% of patients enrolled in the BLOCK-CKD study had eGFR in the range of ≥15 and ≤29 mL/min/1.73 m2, and approximately 90% of patients were taking at least three different antihypertensive medications. The study showed statistically significant reductions of SBP in patients with uncontrolled hypertension. The change in SBP from baseline to day 84 for patients in the 0.5 mg KBP-5074 cohort was −15.9 mm Hg relative to −5.3 mm Hg for the placebo cohort, a model adjusted mean reduction of -10.2 mm Hg (P=0.0026). For patients in the 0.25 mg KBP-5074 cohort, the change in SBP was −11.5 mm Hg compared to −5.3 mm Hg for the placebo cohort; a model adjusted mean reduction of -7.0 mm Hg (P=0.0399). Importantly, KBP-5074 was observed to be well-tolerated in advanced CKD patients, with no reported cases of severe hyperkalemia (potassium levels ≥6 mmol/L), acute kidney injury, or hospitalization due to hyperkalemia. This finding is especially important given that MRAs are typically contraindicated for patients with stage 3b/4 CKD. Further, KBP-5074 demonstrated clinically meaningful trends in the reduction of UACR and reduction in DBP from baseline to day 84.
About KBP-5074
KBP-5074 is a non-steroidal MRA discovered and developed by KBP Biosciences. KBP-5074 selectively binds to recombinant human MRs with much higher affinity than to recombinant human glucocorticoid, progesterone, and androgen receptors, suggesting that KBP-5074 should be effective in blocking the hypertensive and renal tissue damaging effects of aldosterone. KBP-5074 has been investigated in eight phase 1 studies and the BLOCK-CKD phase 2b study. Phase 3 study preparations are underway in close consultation with the FDA’s Division of Cardiology and Nephrology.
About Advanced CKD and Uncontrolled Hypertension
In the US alone, uncontrolled hypertension and stage 3b and 4 CKD afflicts more than 3 million patients in whom currently available MRAs are either contraindicated or must be used with extreme caution due to the risk of hyperkalemia. Treatments that lower blood pressure are available and include ACE-Is, ARBs, and diuretics, among others. Many patients with Stage 3B/4 CKD are at their maximum tolerated dose and still have uncontrolled or resistant hypertension. Available MRAs can provide additional blood pressure control in some of these patients, but usually not without the increased risk of hyperkalemia.
Contacts:
Investor Relations
ir@kbpbiosciences.com
Media:
Public Relations
pr@kbpbiosciences.com