This is a Phase 1b, single center, dose-escalating study evaluating the safety, tolerability, and pharmacodynamic effect of RBT-3 in healthy volunteers and in subjects with stage 3-4 chronic kidney disease.

Start Date21 Oct 2018

Sponsor / Collaborator

Renibus Therapeutics, Inc.

100 Clinical Results associated with RBT-3 (Renibus Therapeutics)

100 Translational Medicine associated with RBT-3 (Renibus Therapeutics)

100 Patents (Medical) associated with RBT-3 (Renibus Therapeutics)

Literatures (Medical) associated with RBT-3 (Renibus Therapeutics)

20 Feb 2021·Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal AssociationQ2 · MEDICINE

Iron sucrose (‘RBT-3’) activates the hepatic and renal HAMP1 gene, evoking renal hepcidin loading and resistance to cisplatin nephrotoxicity

Q2 · MEDICINE

Article

Author: Zager, Richard A ; Johnson, Ali C M ; Therapeutics, Renibus

Abstract:

Background:

Iron sucrose (FeS) administration induces a state of renal preconditioning, protecting against selected forms of acute kidney injury (AKI). Recent evidence suggests that recombinant hepcidin also mitigates acute renal damage. Hence the goals of this study were to determine whether a new proprietary FeS formulation (‘RBT-3’) can acutely activate the hepcidin (HAMP1) gene in humans, raising plasma and renal hepcidin concentrations; assess whether the kidney participates in this posited RBT-3–hepcidin generation response; test whether RBT-3 can mitigate a clinically relevant AKI model (experimental cisplatin toxicity) and explore whether mechanisms in addition to hepcidin generation are operative in RBT-3’s cytoprotective effects.

Methods:

Healthy human volunteers (n = 9) and subjects with Stages 3–4 CKD (n = 9) received 120, 240 or 360 mg of RBT-3 (intravenously over 2 h). Plasma and urine samples were collected and assayed for hepcidin levels (0–72 h post-RBT-3 injection). In complementary mouse experiments, RBT-3 effects on hepatic versus renal hepcidin (HAMP1) messenger RNA (mRNA) and protein levels were compared. RBT-3’s impact on the mouse Nrf2 pathway and on experimental cisplatin nephrotoxicity was assessed. Direct effects of exogenous hepcidin on in vivo and in vitro (HK-2 cells) cisplatin toxicity were also tested.

Results:

RBT-3 induced rapid, dose-dependent and comparable plasma hepcidin increases in both healthy volunteers and chronic kidney disease subjects (∼15 times baseline within 24 h). Human kidney hepcidin exposure was confirmed by 4-fold urinary hepcidin increases. RBT-3 up-regulated mouse hepcidin mRNA, but much more so in kidney (>25 times) versus liver (∼2 times). RBT-3 also activated kidney Nrf2 [increased Nrf2 nuclear binding; increased Nrf2-responsive gene mRNAs: heme oxygenase-1, sulfiredoxin-1, glutamate-cysteine ligase catalytic subunit and NAD(P)H quinone dehydrogenase 1]. RBT-3 preconditioning (18 h time lapse) markedly attenuated experimental cisplatin nephrotoxicity (∼50% blood urea nitrogen/creatinine decrements), in part by reducing renal cisplatin uptake by 40%. Exogenous hepcidin (without RBT-3) treatment conferred protection against mild in vivo (but not in vitro) cisplatin toxicity.

Conclusions:

RBT-3 acutely and dramatically up-regulates cytoprotective hepcidin production, increasing renal hepcidin levels. However, additional cytoprotective mechanisms are activated by RBT-3 (e.g. Nrf2 activation; reduced cisplatin uptake). Thus RBT-3-induced preconditioning likely confers renal resistance to cisplatin via an interplay of multiple cytoprotective activities.

06 Jul 2016·Journal of agricultural and food chemistryQ1 · AGRICULTURAL & FORESTRY SCIENCE

α-Tocopherol Attenuates the Triglyceride- and Cholesterol-Lowering Effects of Rice Bran Tocotrienol in Rats Fed a Western Diet

Q1 · AGRICULTURAL & FORESTRY SCIENCE

Article

Author: Nakagawa, Kiyotaka ; Miyazawa, Teruo ; Shibata, Akira ; Kimura, Toshiyuki ; Kawakami, Yuki

Previous studies demonstrated the ability of tocotrienol (T3) to lower levels of lipids, including cholesterol (Cho) and triglycerides (TG). Although α-tocopherol (α-Toc) reportedly inhibits the hypocholesterolemic effect of T3, there is no information about whether α-Toc influences the TG-lowering effect of T3 in vivo. In this study, we investigated the influence of α-Toc on the antihyperlipidemic effects (Cho- and TG-lowering) of rice bran tocotrienols (RBT3) in F344 rats fed a western diet. α-Toc attenuated both the Cho- and TG-lowering effects of RBT3 in vivo, whereas α-Toc alone exhibited no hypolipidemic effects. RBT3-induced Cpt-1a and Cyp7a1 gene expression was reduced by α-Toc. Furthermore, coadministration of α-Toc decreased liver and adipose tissue concentrations of tocotrienols in F344 rats. These results indicate that α-Toc has almost no antihyperlipidemic effect in vivo, but abrogates the antihyperlipidemic effect of RBT3 by reducing tissue concentrations of tocotrienols and regulating expression of genes involved in lipid metabolism. Understanding the underlying mechanism of the beneficial effects of T3 on lipid metabolism and the interaction with α-Toc will be important for developing T3-based therapeutics.

01 Mar 2007·Clinical and vaccine immunology : CVI

Application of the Fluorescence Polarization Assay for Detection of Caprine Antibodies to Brucella melitensis in Areas of High Prevalence and Widespread Vaccination

Article

Author: Nielsen, K. ; Gomez-Flores, R. ; Rodríguez-Padilla, C. ; Smith, P. ; Ramírez-Pfeiffer, C. ; Marín-Ricalde, F.

ABSTRACT:

The screening Rose Bengal test (RBT), the buffered plate agglutination test (BPAT), and the confirmatory complement fixation test (CFT) are currently approved by the World Organization for Animal Health (OIE) for diagnosis of goat brucellosis. However, RBT (at 3% or 8% cell concentration) is known to be affected by vaccinal antibodies. In the present study, Mexican and Canadian OIE tests were compared with the fluorescence polarization assay (FPA), alone or in combination, using indirect and competitive enzyme-linked immunosorbent assays as classification variables for goat sera obtained from an area of high prevalence and widespread vaccination. The relative sensitivities and specificities were, respectively, 99.7% and 32.5% for RBT3, 92.8% and 68.8% for RBT8, 98.4% and 84.8% for Canadian CFT, 83.7% and 65.5% for Mexican CFT, and 78.1% and 89.3% for FPA. The use of FPA as the confirmatory test in combination with other tests significantly increased the final specificities of the screening tests alone; BPAT, RBT3, and RBT8 plus FPA resulted in final specificities of 90%, 91.2%, and 91.3%, respectively, whereas for the combinations RBT3 plus Mexican CFT, RBT8 plus Mexican CFT, and BPAT plus Canadian CFT, specificities were 65.5%, 63.2%, and 91.7%, respectively. We suggest that FPA may be routinely applied as an adaptable screening test for diagnosis of goat brucellosis and as a confirmatory test for screening test series. Some advantages of FPA are that its cutoff can be adjusted to improve its sensitivity or specificity, it is a low-cost and easy-to-perform test of choice when specificity is relevant or when an alternative confirmatory test is not available, and it is not affected by vaccination, thus reducing the number of misdiagnosed and killed goats.

News (Medical) associated with RBT-3 (Renibus Therapeutics)

21 Mar 2024

·www.renibus.com

Renibus Announces Leadership Transition

Jeffrey Keyser, RPh, JD, PhD, co-Founder and Former co-CEO, Appointed President & CEO Southlake, Texas, March 21, 2024 – Renibus Therapeutics® (“Renibus”), a clinical-stage biopharmaceutical company focusing on the prevention and treatment of cardio-renal and metabolic diseases, today announced a transition in its leadership structure. As part of this change, Frank Stonebanks, former co-CEO, has left the company to pursue new opportunities. Renibus wishes Mr. Stonebanks the best in his future endeavors. Jeffrey Keyser, RPh, JD, PhD, co-founder and former co-CEO, has been appointed President and CEO of Renibus. Dr. Keyser is a veteran of the biopharmaceutical industry with a track record of success. Prior to co-founding Renibus, Dr. Keyser invented the Mucinex product line for Adams Respiratory Therapeutics, Inc. and co-founded ZS Pharma, Inc. (acquired by Astra Zeneca Plc). His leadership has been instrumental in Renibus’ success to date and he is well positioned to lead the company into its next phase of growth and innovation. About Renibus Therapeutics Renibus is a clinical stage biopharmaceutical company dedicated to treating, improving, and extending patients’ lives by developing products to prevent disease progression, improve outcomes and protect against organ damage associated with cardio, renal and metabolic diseases. Renibus’ first-in-a-new class lead program is RBT-1 (stannic protoporfin / iron sucrose), a single dose IV drug that is given over 1-2 hours, 24-48 hours prior to patients undergoing elective cardiac and/or valve surgery. It is in a Phase 3 pivotal trial to reduce the risk of post operative complications and improve outcomes following cardiothoracic surgery. The drug has received FDA Breakthrough and Fast Track Designations. Veverimer is an oral, non-absorbed hydrochloric acid binder that was acquired from Tricida. We are currently evaluating veverimer in preclinical models and analyzing historical data to further our understanding of its clinical profile with a goal of identifying an indication for evaluation in a Phase 2 trial. RBT-3 (iron sucrose), one component of RBT-1, is a novel, low molecular weight iron nanoparticle that has the potential to rapidly restore iron levels and improve blood product utilization in cardiac surgery and/or ER patients. RBT-3 has also demonstrated the potential to mitigate cisplatin induced nephrotoxicity in preclinical models. We are currently exploring opportunities to further the clinical development of RBT-3 in these potential indications. RBT-9 (stannic protoporfin), another component of RBT-1, is a potent anti-inflammatory and antioxidant drug. It has completed Phase 1 (as part of the RBT-1 program) and has been investigated in a 42-patient Phase 2, randomized, placebo-controlled trial in high-risk patients with COVID-19. The data from this trial indicated that RBT-9 has the potential to significantly improve clinical outcomes. Additional work is underway to help inform the future clinical development strategy. RBT-2 (tetrahydrocurcumin) is an oral antioxidant and antifibrotic drug that is in IND enabling studies targeting delaying CKD progression. For more information, please visit the Company’s website at www.Renibus.com and engage with us on LinkedIn. Investor and Media Contact: Amy Conrad Juniper Point amy@juniper-point.com 858-914-1962 Business Development Contact Jamie Donadio CFO, Renibus jdonadio@renibus.com

Phase 2Phase 1Phase 3Fast TrackExecutive Change

22 Feb 2024

·www.prnewswire.com

Renibus Therapeutics to Present at the Evercore ISI 2024 Emerging Biotech Conference

SOUTHLAKE, Texas, Feb. 22, 2024 /PRNewswire/ -- Renibus Therapeutics® ("Renibus"), a clinical-stage biopharmaceutical company focusing on the prevention and treatment of cardio, renal and metabolic diseases, today announced that Frank Stonebanks, Renibus' Co-CEO, and Bhupinder Singh, MD, Renibus' CMO, will participate in a fireside chat on February 29, 2024, at 3:25 pm ET at the Evercore ISI 2024 Emerging Biotech Conference, taking place virtually from February 28-29, 2024. Renibus management will also participate in one-on-one meetings with investors during the conference. To view the fireside chat, please visit the events section of the Renibus website at News and Events - Renibus Therapeutics. About Renibus Therapeutics Renibus is a clinical stage biopharmaceutical company dedicated to treating, improving, and extending patients' lives by developing products to prevent disease progression, improve outcomes and protect against organ damage associated with cardio, renal and metabolic diseases. Renibus' first-in-a-new-class lead program is RBT-1, which is in a Phase 3 pivotal trial to show a reduction in post-operative complications and improve outcomes following cardiac surgery. The drug has received FDA Breakthrough and Fast Track Designations. Veverimer (Alezuris™) is an oral, non-absorbed hydrochloric acid binder that was acquired from Tricida. We are currently evaluating veverimer in preclinical models and analyzing historical data to further our understanding of its clinical profile, with a goal of identifying an indication for evaluation in a Phase 2 trial. RBT-3 (iron sucrose), one component of RBT-1, is a novel, low molecular weight iron nanoparticle that has the potential to rapidly restore iron levels and improve blood product utilization in cardiac surgery and/or ER patients. RBT-3 has also demonstrated the potential to mitigate cisplatin induced nephrotoxicity in preclinical models. We are currently exploring opportunities to further the clinical development of RBT-3 in these potential indications. RBT-9 (stannic protoporfin), another component of RBT-1, is a potent anti-inflammatory and antioxidant drug. It has completed Phase 1 (as part of the RBT-1 program) and has been investigated in a 42-patient Phase 2, randomized, placebo-controlled trial in high-risk patients with COVID-19. The data from this trial indicated that RBT-9 has the potential to significantly improve clinical outcomes. Additional work is underway to help inform the future clinical development strategy. RBT-2 (tetrahydrocurcumin) is an oral antioxidant and antifibrotic drug that may have the potential to delay CKD progression. For more information, please visit the Company's website at and engage with us on LinkedIn. Investor and Media Contact: Amy Conrad Juniper Point [email protected] 858-914-1962 Business Development Contact Frank Stonebanks Co-CEO, Renibus [email protected] SOURCE Renibus Therapeutics

Phase 2Fast TrackPhase 1Phase 3

07 Feb 2024

·www.prnewswire.com

Renibus Therapeutics Announces Presentation at Oppenheimer 34th Annual Healthcare Conference

SOUTHLAKE, Texas, Feb. 7, 2024 /PRNewswire/ -- Renibus Therapeutics® ("Renibus"), a clinical-stage biopharmaceutical company focusing on the prevention and treatment of cardio, renal and metabolic diseases, today announced that Frank Stonebanks, Renibus' Co-CEO, will present a company overview on February 14, 2024, at 2:40 pm ET at the Oppenheimer 34th Annual Healthcare Conference, taking place virtually from February 13-14, 2024. Renibus management will also participate in one-on-one meetings with investors during the conference. About Renibus Therapeutics Renibus is a clinical stage biopharmaceutical company dedicated to treating, improving, and extending patients' lives by developing products to prevent disease progression, improve outcomes and protect against organ damage associated with cardio, renal and metabolic diseases. Renibus' first-in-a-new class lead program is RBT-1 (stannic protoporfin / iron sucrose), a single dose IV drug that is given over 1-2 hours, 24-48 hours prior to patients undergoing elective cardiac and/or valve surgery. It is in a Phase 3 pivotal trial to reduce the risk of post operative complications and improve outcomes following cardiothoracic surgery. The drug has received FDA Breakthrough and Fast Track Designations. Veverimer (Alezuris™) is an oral, non-absorbed hydrochloric acid binder that was acquired from Tricida. We are currently evaluating veverimer in preclinical models and analyzing historical data to further our understanding of its clinical profile with a goal of identifying an indication for evaluation in a Phase 2 trial. RBT-3 (iron sucrose), one component of RBT-1, is a novel, low molecular weight iron nanoparticle that has the potential to rapidly restore iron levels and improve blood product utilization in cardiac surgery and/or ER patients. RBT-3 has also demonstrated the potential to mitigate cisplatin induced nephrotoxicity in preclinical models. We are currently exploring opportunities to further the clinical development of RBT-3 in these potential indications. RBT-9 (stannic protoporfin), another component of RBT-1, is a potent anti-inflammatory and antioxidant drug. It has completed Phase 1 (as part of the RBT-1 program) and has been investigated in a 42-patient Phase 2, randomized, placebo-controlled trial in high-risk patients with COVID-19. The data from this trial indicated that RBT-9 has the potential to significantly improve clinical outcomes. Additional work is underway to help inform the future clinical development strategy. RBT-2 (tetrahydrocurcumin) is an oral antioxidant and antifibrotic drug that is in IND enabling studies targeting delaying CKD progression. For more information, please visit the Company's website at and engage with us on LinkedIn. Investor and Media Contact: Amy Conrad Juniper Point [email protected] 858-914-1962 Business Development Contact Frank Stonebanks Co-CEO, Renibus fstonebanks@renibus.com SOURCE Renibus Therapeutics

Phase 2Fast TrackPhase 3Phase 1

100 Deals associated with RBT-3 (Renibus Therapeutics)

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Non-diabetic Chronic Kidney Disease	Phase 1	United States	Renibus Therapeutics, Inc.	21 Oct 2018

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASN2020	Phase 1	Anemia, Iron-Deficiency	18	RBT-3 120 mg	sqktsrbxxi(ktxaebzkmq) = no serious AEs (SAEs) were reported hjpskrfebh (emticufzvs ) View more	Positive	19 Oct 2020
				RBT-3 240 mg
NCT04072432 (CTgov)	Phase 1	Non-diabetic Chronic Kidney Disease	18	RBT-3 (120 mg)	pyecyedvzo(xvcjxudvvq) = cjwhtdjzme myfpbsaili (umxybhvxdq, figcglfjdz - soudsxmoid) View more	-	03 Mar 2020
				RBT-3 (240 mg)	pyecyedvzo(xvcjxudvvq) = qgabtibsup myfpbsaili (umxybhvxdq, tugvmzdges - yahhiivywb) View more

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