Delving into the Latest Updates on SBR-759 with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Phosphate binder, Seboren

+ [1]

Target

Phosphates

Action

modulators

Mechanism

Phosphates modulators(Phosphates modulators)

Therapeutic Areas

Endocrinology and Metabolic DiseaseUrogenital Diseases

Active Indication-

Inactive Indication

Chronic Kidney DiseasesHyperphosphatemia

Originator Organization

Sebo Pharma

Active Organization-

Inactive Organization

Novartis Pharmaceuticals Corp.

Novartis AGNovartis Pharma AG

+ [3]

Drug Highest PhaseDiscontinuedPhase 3

First Approval Date-

Regulation-

Login to view timeline

:It is estimated that by 2040, Chronic Kidney Disease (CKD) will be the 5th main cause of global deaths. It has been suggested that hyperphosphatemia is among the main factors leading to the increased risk of death. This review focuses on potential and currently used Phosphate Binders (PB). Aluminum hydroxide is presently not recommended due to potential aluminum toxicity. Calciumcontaining phosphate binders (CCPB) can cause calcium overload, resulting in hypercalcemia and an increased risk of cardiovascular diseases. Magnesium and calcium complexes were suggested to be as effective as sevelamer in the reduction of serum phosphate, with the potential to slow down the process of calcification. However, limited studies have been conducted in this area. Although sevelamer seemed to have a positive influence on cardiovascular calcification and arterial stiffness, its influence on mortality was unclear. Sevelamer crystal accumulation in the Gastrointestinal tract (GI) can cause gastrointestinal bleeding. Lanthanum carbonate seemed to lower all-cause mortality and reduce the chance of hypercalcemia, even though a deposit in the GI tract was observed. Colestilan, like sevelamer, reduced LDL cholesterol. Sucroferric oxyhydroxide had a lower pill burden than other PBs and it seemed to reduce serum FGF-23. Ferric citrate improved parameters that are related to anemia but can cause iron overload. Bixalomer appeared to have fewer gastrointestinal side effects than sevelamer. Nano-lanthanum hydroxide and SBR759 may have an interesting future as PBs. In conclusion, the development of new PBs should also take into consideration their potential to function as protection modifiers.

01 Sep 2021·International Urology and NephrologyQ4 · MEDICINE

Using iron-based phosphate binders in phosphate reduction and anemia improvement in patients receiving dialysis: a meta-analysis of randomized controlled trials

Q4 · MEDICINE

Article

Author: Zhu, Yan ; Rao, Jinlan ; Liao, Xueling ; Li, Wei ; Xue, Chao ; Ou, Jihong

PURPOSEA study was conducted to determine whether iron-based phosphate binders (IBPBs) need to be preferred for hyperphosphatemia and anemia management in patients on dialysis.METHODSFor this meta-analysis, we searched PubMed, Embase, and Cochrane Central Register of Controlled Trials for randomized controlled trials that evaluated the efficacy and safety of IBPBs in decreasing phosphate and correcting anemia in dialysis patients.RESULTSNineteen trials comprising 4719 participants were included. Compared with placebo, serum phosphate decreased significantly after treatment with ferric citrate (FC), fermagate (one study), and SBR759 (one study). Hemoglobin increased significantly after treatment with FC and sucroferric oxyhydroxide (PA21). In addition, FC and PA21 reduced serum intact parathyroid hormone (iPTH) and increased ferritin and transferrin saturation, but SBR759 did not. Compared with active treatment, the non-inferiority of IBPBs in reducing serum phosphate and iPTH was demonstrated. FC significantly improved serum hemoglobin and iron-related parameters and decreased the use of intravenous iron and erythropoiesis-stimulating agent, whereas PA21 did not increase serum hemoglobin level. The incidences of infection and hospitalization were similar between the two groups, with FC having a higher risk of diarrhea than the placebo and active treatments.CONCLUSIONFC was associated with the control of hyperphosphatemia and the improvement of anemia. However, PA21 did not show superiority for alleviating anemia compared with the active treatment. Other IBPBs, such as fermagate and SBR759, remained poorly understood due to the limited number of studies. Further trials are required to assess the effect of IBPBs on the risk of cardiovascular events and all-cause mortality.

01 Feb 2019·Nephrology Dialysis TransplantationQ2 · MEDICINE

The effects of tenapanor on serum fibroblast growth factor 23 in patients receiving hemodialysis with hyperphosphatemia

Q2 · MEDICINE

Article

Author: Yan, Andrew ; Rosenbaum, David P ; Block, Geoffrey A ; Greasley, Peter J ; Wolf, Myles ; Chertow, Glenn M

BackgroundElevated serum fibroblast growth factor 23 (FGF23) is strongly associated with cardiovascular risk and mortality. Tenapanor, an inhibitor of gastrointestinal sodium/hydrogen exchanger isoform 3, decreased serum phosphate in a randomized, double-blind, placebo-controlled Phase 2 trial (ClinicalTrials.gov identifier NCT02081534) of patients receiving hemodialysis with hyperphosphatemia. Here, we report a secondary analysis of effects on serum FGF23 during that study.MethodsAfter 1-3 weeks of washout of phosphate binders, 162 patients were randomized to receive 4 weeks of treatment with placebo or one of six tenapanor regimens (3 or 30 mg once daily, or 1, 3, 10 or 30 mg twice daily). Intact FGF23 concentrations were determined from serum samples collected at screening, post-washout and end of treatment, assayed in duplicate in a single batch at the end of the study.ResultsAfter phosphate-binder washout, serum FGF23 concentrations increased in all groups [range of geometric means: 1430-2605 pg/mL before, to 2601-6294 pg/mL after washout (P < 0.001 for all patients analyzed as a single group)]. Serum FGF23 concentrations subsequently decreased in tenapanor-treated patients (2030-3563 pg/mL), whereas they increased further in placebo-treated patients (6930 pg/mL). In an analysis of covariance, FGF23 decreased by 9.1-27.9% in tenapanor-treated patients and increased by 21.9% in placebo-treated patients (P ≤ 0.001-0.04).ConclusionsFollowing a marked increase in serum FGF23 in response to withdrawal of phosphate binders, tenapanor significantly decreased serum FGF23 in patients receiving hemodialysis with hyperphosphatemia. Further studies are required to explore the long-term effects of controlling FGF23 with tenapanor.

1

News (Medical) associated with SBR-759

18 Jul 2024

·firstwordpharma.com

Ardelyx takes CMS to court over ending Medicare Part D coverage for Xphozah

Ardelyx has filed a lawsuit against the US Department of Health and Human Services and the Centers for Medicare and Medicaid Services (CMS) over their decision to include Xphozah (tenapanor) and other oral-only phosphate-lowering therapies (PLTs) in the bundled payment system for dialysis recipients. Starting January 1 next year, CMS plans on moving Xphozah and other PLTs to the End-Stage Renal Disease Prospective Payment System (ESRD PPS), thereby ending their coverage under Medicare Part D. However, Ardelyx claims these drugs are not administered at dialysis centres and cannot be taken during maintenance dialysis sessions, making it crucial for patients to obtain them through outpatient pharmacy benefit plans. Earlier this month, the drugmaker decided against filing for Transitional Drug Add-on Payment Adjustment (TDAPA) to preserve patient access to its medication.The suit – also backed by the advocacy groups American Association of Kidney Patients (AAKP) and National Minority Quality Forum (NMQF) – contests that the CMS’ decision is likely to “significantly and negatively impact patient choice of and timely access to important medications.” The planned move will also disincentivise “development of new…medicines that can…address unmet needs in an already underserved therapeutic area,” said Mike Raab, chief executive of Ardelyx. The company has remained a strong supporter of bipartisan legislation, dubbed the Kidney PATIENT Act, introduced to the US Senate to delay the inclusion of oral PLTs in the ESRD PPS. Jefferies analysts said the “uncertainty around Congress' ability to delay oral phosphate binders from moving into the dialysis bundle” was likely to hurt investors’ sentiment on Xphozah, adding that an expert predicted a 65% to 75% chance of Congress passing the legislation by the year-end.Ardelyx, which inhibits phosphate absorption through its primary pathway, was cleared in the US last year after a previous regulatory hurdle, as an add-on therapy to lower serum phosphorus in patients on dialysis who are refractory or intolerant to phosphate-binder therapies alone. Such patients now risk losing access to an “FDA-approved therapy that is providing them a meaningful clinical benefit,” Raab added. In a FirstWord poll of US nephrologists conducted last year, over 60% of respondents said they would consider switching patients to Ardelyx from another drug for hyperphosphataemia.

Patent Infringement

100 Deals associated with SBR-759

Login to view more data

R&D Status

10 top R&D records.

Login

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Chronic Kidney Diseases	Phase 3	Italy	Novartis AG	01 Feb 2010
Chronic Kidney Diseases	Phase 3	Belgium	Novartis AG	01 Feb 2010
Hyperphosphatemia	Phase 3	-	Sebo Pharma	-
Hyperphosphatemia	Phase 3	-	Sebo Pharma	-

Login to view more data

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03824587 (AMPLIFY \| TEN-02-202 , CTgov)	Phase 2/3	Hyperphosphatemia \| Kidney Failure, Chronic	236	Tenapanor+Phosphate Binder Agents (Tenapanor 30 mg BID)	nyyehohtem(zaswfftxig) = wimayvovbb atbqnsavlz (irlneupgjm, tabcmfqaow - gbpjhspatr) View more	-	06 Mar 2023
				Placebo+Phosphate Binder Agents (Placebo)	nyyehohtem(zaswfftxig) = ydwazuroeu atbqnsavlz (irlneupgjm, kttnwbdkji - bhobhqeiol) View more
NCT00704483 \| NCT00704678 \| NCT01069692 (SBR759, ASN2010)	Phase 3	Hemodialysis complication	203	SBR759	ahjeepjmoc(xcnlslkpri) = more frequent with SBR759 zkqxtncoqb (oyzlasbrrw ) View more	Positive	16 Nov 2010
				Sevelamer-HCl
NCT00704483 \| NCT00704678 \| NCT01069692 (SBR759, ASN2010)	Phase 2	Hyperphosphatemia \| Chronic Kidney Diseases	203	SBR759 3.0g	nezxcxdfqh(hifexilxiw) = Similar incidences of SAE/AE were seen with SBR759 and S-HCl (5.2/90.3% vs 4.4/94.1%); no SAE was drug-related. Overall discontinuation rates were lower with SBR759 (11.9% vs 20.6%) as well as discontinuation due to AE (3.7% vs 13.2%). Most frequent AE category with SBR759 and S-HCl was gastrointestinal (GI) disorders (57.5% vs 64.7%). GI AE intensity was mostly mild with SBR759 (mild 45.5%, moderate 11.2%; severe 0.7%) whereas with S-HCl more moderate and severe AEs were reported (mild 30.9%; moderate 27.9%; severe 5.9%). Diarrhea AEs were more frequent with SBR759 (19.4% vs 10.3%); constipation and abdominal distension affected more patients on S-HCl (5.2% and 25.0% vs 3.0% and 25.0%, respectively). Based on Deficiency of Acquired Immune Deficiency Syndrome (DAIDS) grading, majority of diarrhea AE were of grade 1 (lowest severity) with SBR759 and S-HCl (18.7% vs 10.3%) xktfogtvfh (spgywcypbg )	Positive	16 Nov 2010
				Sevelamer Hydrochloride 2.4g