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Research ArticleEndocrine and Diabetes

The Novel Phosphate and Bile Acid Sequestrant Polymer SAR442357 Delays Disease Progression in a Rat Model of Diabetic Nephropathy

Tamara R. Castañeda, María Méndez, Ian Davison, Ralf Elvert, Uwe Schwahn, Galina Boldina, Corinne Rocher, Petra Scherer, Kuldeep Singh, Dinesh S. Bangari, Mechthilde Falkenhahn, Aimo Kannt, Anish Konkar, Philip J. Larsen, Cynthia Arbeeny, Pradeep K. Dhal and Thomas Hübschle
Journal of Pharmacology and Experimental Therapeutics February 2021, 376 (2) 190-203; DOI: https://doi.org/10.1124/jpet.120.000285
Tamara R. Castañeda
R&D Diabetes (T.R.C., R.E., A.Ka., A.Ko., P.J.L., C.A., T.H.), Integrated Drug Discovery (M.M.), Biomarkers and Clinical Bioanalysis (U.S.), Translational In Vivo Models, Global Discovery Pathology (P.S.), and Global Research Project Management (M.F.), Sanofi-Aventis Deutschland GmbH, Industriepark Höchst, Frankfurt, Germany; C&BD Haverhill Operations, Sanofi GB Genzyme Limited, Haverhill, Suffolk, United Kingdom (I.D.); R&D Translational Sciences France, Bioinformatics, Sanofi, Chilly-Mazarin Cedex, France (C.R.); Translational In Vivo Models, Global Discovery Pathology, Framingham, Massachusetts (K.S., D.S.B.); and Pharmaceutical Development Platform, Sanofi Global R&D, Waltham, Massachusetts (P.K.D.)
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María Méndez
R&D Diabetes (T.R.C., R.E., A.Ka., A.Ko., P.J.L., C.A., T.H.), Integrated Drug Discovery (M.M.), Biomarkers and Clinical Bioanalysis (U.S.), Translational In Vivo Models, Global Discovery Pathology (P.S.), and Global Research Project Management (M.F.), Sanofi-Aventis Deutschland GmbH, Industriepark Höchst, Frankfurt, Germany; C&BD Haverhill Operations, Sanofi GB Genzyme Limited, Haverhill, Suffolk, United Kingdom (I.D.); R&D Translational Sciences France, Bioinformatics, Sanofi, Chilly-Mazarin Cedex, France (C.R.); Translational In Vivo Models, Global Discovery Pathology, Framingham, Massachusetts (K.S., D.S.B.); and Pharmaceutical Development Platform, Sanofi Global R&D, Waltham, Massachusetts (P.K.D.)
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Ian Davison
R&D Diabetes (T.R.C., R.E., A.Ka., A.Ko., P.J.L., C.A., T.H.), Integrated Drug Discovery (M.M.), Biomarkers and Clinical Bioanalysis (U.S.), Translational In Vivo Models, Global Discovery Pathology (P.S.), and Global Research Project Management (M.F.), Sanofi-Aventis Deutschland GmbH, Industriepark Höchst, Frankfurt, Germany; C&BD Haverhill Operations, Sanofi GB Genzyme Limited, Haverhill, Suffolk, United Kingdom (I.D.); R&D Translational Sciences France, Bioinformatics, Sanofi, Chilly-Mazarin Cedex, France (C.R.); Translational In Vivo Models, Global Discovery Pathology, Framingham, Massachusetts (K.S., D.S.B.); and Pharmaceutical Development Platform, Sanofi Global R&D, Waltham, Massachusetts (P.K.D.)
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Ralf Elvert
R&D Diabetes (T.R.C., R.E., A.Ka., A.Ko., P.J.L., C.A., T.H.), Integrated Drug Discovery (M.M.), Biomarkers and Clinical Bioanalysis (U.S.), Translational In Vivo Models, Global Discovery Pathology (P.S.), and Global Research Project Management (M.F.), Sanofi-Aventis Deutschland GmbH, Industriepark Höchst, Frankfurt, Germany; C&BD Haverhill Operations, Sanofi GB Genzyme Limited, Haverhill, Suffolk, United Kingdom (I.D.); R&D Translational Sciences France, Bioinformatics, Sanofi, Chilly-Mazarin Cedex, France (C.R.); Translational In Vivo Models, Global Discovery Pathology, Framingham, Massachusetts (K.S., D.S.B.); and Pharmaceutical Development Platform, Sanofi Global R&D, Waltham, Massachusetts (P.K.D.)
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Uwe Schwahn
R&D Diabetes (T.R.C., R.E., A.Ka., A.Ko., P.J.L., C.A., T.H.), Integrated Drug Discovery (M.M.), Biomarkers and Clinical Bioanalysis (U.S.), Translational In Vivo Models, Global Discovery Pathology (P.S.), and Global Research Project Management (M.F.), Sanofi-Aventis Deutschland GmbH, Industriepark Höchst, Frankfurt, Germany; C&BD Haverhill Operations, Sanofi GB Genzyme Limited, Haverhill, Suffolk, United Kingdom (I.D.); R&D Translational Sciences France, Bioinformatics, Sanofi, Chilly-Mazarin Cedex, France (C.R.); Translational In Vivo Models, Global Discovery Pathology, Framingham, Massachusetts (K.S., D.S.B.); and Pharmaceutical Development Platform, Sanofi Global R&D, Waltham, Massachusetts (P.K.D.)
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Galina Boldina
R&D Diabetes (T.R.C., R.E., A.Ka., A.Ko., P.J.L., C.A., T.H.), Integrated Drug Discovery (M.M.), Biomarkers and Clinical Bioanalysis (U.S.), Translational In Vivo Models, Global Discovery Pathology (P.S.), and Global Research Project Management (M.F.), Sanofi-Aventis Deutschland GmbH, Industriepark Höchst, Frankfurt, Germany; C&BD Haverhill Operations, Sanofi GB Genzyme Limited, Haverhill, Suffolk, United Kingdom (I.D.); R&D Translational Sciences France, Bioinformatics, Sanofi, Chilly-Mazarin Cedex, France (C.R.); Translational In Vivo Models, Global Discovery Pathology, Framingham, Massachusetts (K.S., D.S.B.); and Pharmaceutical Development Platform, Sanofi Global R&D, Waltham, Massachusetts (P.K.D.)
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Corinne Rocher
R&D Diabetes (T.R.C., R.E., A.Ka., A.Ko., P.J.L., C.A., T.H.), Integrated Drug Discovery (M.M.), Biomarkers and Clinical Bioanalysis (U.S.), Translational In Vivo Models, Global Discovery Pathology (P.S.), and Global Research Project Management (M.F.), Sanofi-Aventis Deutschland GmbH, Industriepark Höchst, Frankfurt, Germany; C&BD Haverhill Operations, Sanofi GB Genzyme Limited, Haverhill, Suffolk, United Kingdom (I.D.); R&D Translational Sciences France, Bioinformatics, Sanofi, Chilly-Mazarin Cedex, France (C.R.); Translational In Vivo Models, Global Discovery Pathology, Framingham, Massachusetts (K.S., D.S.B.); and Pharmaceutical Development Platform, Sanofi Global R&D, Waltham, Massachusetts (P.K.D.)
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Petra Scherer
R&D Diabetes (T.R.C., R.E., A.Ka., A.Ko., P.J.L., C.A., T.H.), Integrated Drug Discovery (M.M.), Biomarkers and Clinical Bioanalysis (U.S.), Translational In Vivo Models, Global Discovery Pathology (P.S.), and Global Research Project Management (M.F.), Sanofi-Aventis Deutschland GmbH, Industriepark Höchst, Frankfurt, Germany; C&BD Haverhill Operations, Sanofi GB Genzyme Limited, Haverhill, Suffolk, United Kingdom (I.D.); R&D Translational Sciences France, Bioinformatics, Sanofi, Chilly-Mazarin Cedex, France (C.R.); Translational In Vivo Models, Global Discovery Pathology, Framingham, Massachusetts (K.S., D.S.B.); and Pharmaceutical Development Platform, Sanofi Global R&D, Waltham, Massachusetts (P.K.D.)
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Kuldeep Singh
R&D Diabetes (T.R.C., R.E., A.Ka., A.Ko., P.J.L., C.A., T.H.), Integrated Drug Discovery (M.M.), Biomarkers and Clinical Bioanalysis (U.S.), Translational In Vivo Models, Global Discovery Pathology (P.S.), and Global Research Project Management (M.F.), Sanofi-Aventis Deutschland GmbH, Industriepark Höchst, Frankfurt, Germany; C&BD Haverhill Operations, Sanofi GB Genzyme Limited, Haverhill, Suffolk, United Kingdom (I.D.); R&D Translational Sciences France, Bioinformatics, Sanofi, Chilly-Mazarin Cedex, France (C.R.); Translational In Vivo Models, Global Discovery Pathology, Framingham, Massachusetts (K.S., D.S.B.); and Pharmaceutical Development Platform, Sanofi Global R&D, Waltham, Massachusetts (P.K.D.)
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Dinesh S. Bangari
R&D Diabetes (T.R.C., R.E., A.Ka., A.Ko., P.J.L., C.A., T.H.), Integrated Drug Discovery (M.M.), Biomarkers and Clinical Bioanalysis (U.S.), Translational In Vivo Models, Global Discovery Pathology (P.S.), and Global Research Project Management (M.F.), Sanofi-Aventis Deutschland GmbH, Industriepark Höchst, Frankfurt, Germany; C&BD Haverhill Operations, Sanofi GB Genzyme Limited, Haverhill, Suffolk, United Kingdom (I.D.); R&D Translational Sciences France, Bioinformatics, Sanofi, Chilly-Mazarin Cedex, France (C.R.); Translational In Vivo Models, Global Discovery Pathology, Framingham, Massachusetts (K.S., D.S.B.); and Pharmaceutical Development Platform, Sanofi Global R&D, Waltham, Massachusetts (P.K.D.)
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Mechthilde Falkenhahn
R&D Diabetes (T.R.C., R.E., A.Ka., A.Ko., P.J.L., C.A., T.H.), Integrated Drug Discovery (M.M.), Biomarkers and Clinical Bioanalysis (U.S.), Translational In Vivo Models, Global Discovery Pathology (P.S.), and Global Research Project Management (M.F.), Sanofi-Aventis Deutschland GmbH, Industriepark Höchst, Frankfurt, Germany; C&BD Haverhill Operations, Sanofi GB Genzyme Limited, Haverhill, Suffolk, United Kingdom (I.D.); R&D Translational Sciences France, Bioinformatics, Sanofi, Chilly-Mazarin Cedex, France (C.R.); Translational In Vivo Models, Global Discovery Pathology, Framingham, Massachusetts (K.S., D.S.B.); and Pharmaceutical Development Platform, Sanofi Global R&D, Waltham, Massachusetts (P.K.D.)
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Aimo Kannt
R&D Diabetes (T.R.C., R.E., A.Ka., A.Ko., P.J.L., C.A., T.H.), Integrated Drug Discovery (M.M.), Biomarkers and Clinical Bioanalysis (U.S.), Translational In Vivo Models, Global Discovery Pathology (P.S.), and Global Research Project Management (M.F.), Sanofi-Aventis Deutschland GmbH, Industriepark Höchst, Frankfurt, Germany; C&BD Haverhill Operations, Sanofi GB Genzyme Limited, Haverhill, Suffolk, United Kingdom (I.D.); R&D Translational Sciences France, Bioinformatics, Sanofi, Chilly-Mazarin Cedex, France (C.R.); Translational In Vivo Models, Global Discovery Pathology, Framingham, Massachusetts (K.S., D.S.B.); and Pharmaceutical Development Platform, Sanofi Global R&D, Waltham, Massachusetts (P.K.D.)
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Anish Konkar
R&D Diabetes (T.R.C., R.E., A.Ka., A.Ko., P.J.L., C.A., T.H.), Integrated Drug Discovery (M.M.), Biomarkers and Clinical Bioanalysis (U.S.), Translational In Vivo Models, Global Discovery Pathology (P.S.), and Global Research Project Management (M.F.), Sanofi-Aventis Deutschland GmbH, Industriepark Höchst, Frankfurt, Germany; C&BD Haverhill Operations, Sanofi GB Genzyme Limited, Haverhill, Suffolk, United Kingdom (I.D.); R&D Translational Sciences France, Bioinformatics, Sanofi, Chilly-Mazarin Cedex, France (C.R.); Translational In Vivo Models, Global Discovery Pathology, Framingham, Massachusetts (K.S., D.S.B.); and Pharmaceutical Development Platform, Sanofi Global R&D, Waltham, Massachusetts (P.K.D.)
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Philip J. Larsen
R&D Diabetes (T.R.C., R.E., A.Ka., A.Ko., P.J.L., C.A., T.H.), Integrated Drug Discovery (M.M.), Biomarkers and Clinical Bioanalysis (U.S.), Translational In Vivo Models, Global Discovery Pathology (P.S.), and Global Research Project Management (M.F.), Sanofi-Aventis Deutschland GmbH, Industriepark Höchst, Frankfurt, Germany; C&BD Haverhill Operations, Sanofi GB Genzyme Limited, Haverhill, Suffolk, United Kingdom (I.D.); R&D Translational Sciences France, Bioinformatics, Sanofi, Chilly-Mazarin Cedex, France (C.R.); Translational In Vivo Models, Global Discovery Pathology, Framingham, Massachusetts (K.S., D.S.B.); and Pharmaceutical Development Platform, Sanofi Global R&D, Waltham, Massachusetts (P.K.D.)
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Cynthia Arbeeny
R&D Diabetes (T.R.C., R.E., A.Ka., A.Ko., P.J.L., C.A., T.H.), Integrated Drug Discovery (M.M.), Biomarkers and Clinical Bioanalysis (U.S.), Translational In Vivo Models, Global Discovery Pathology (P.S.), and Global Research Project Management (M.F.), Sanofi-Aventis Deutschland GmbH, Industriepark Höchst, Frankfurt, Germany; C&BD Haverhill Operations, Sanofi GB Genzyme Limited, Haverhill, Suffolk, United Kingdom (I.D.); R&D Translational Sciences France, Bioinformatics, Sanofi, Chilly-Mazarin Cedex, France (C.R.); Translational In Vivo Models, Global Discovery Pathology, Framingham, Massachusetts (K.S., D.S.B.); and Pharmaceutical Development Platform, Sanofi Global R&D, Waltham, Massachusetts (P.K.D.)
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Pradeep K. Dhal
R&D Diabetes (T.R.C., R.E., A.Ka., A.Ko., P.J.L., C.A., T.H.), Integrated Drug Discovery (M.M.), Biomarkers and Clinical Bioanalysis (U.S.), Translational In Vivo Models, Global Discovery Pathology (P.S.), and Global Research Project Management (M.F.), Sanofi-Aventis Deutschland GmbH, Industriepark Höchst, Frankfurt, Germany; C&BD Haverhill Operations, Sanofi GB Genzyme Limited, Haverhill, Suffolk, United Kingdom (I.D.); R&D Translational Sciences France, Bioinformatics, Sanofi, Chilly-Mazarin Cedex, France (C.R.); Translational In Vivo Models, Global Discovery Pathology, Framingham, Massachusetts (K.S., D.S.B.); and Pharmaceutical Development Platform, Sanofi Global R&D, Waltham, Massachusetts (P.K.D.)
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Thomas Hübschle
R&D Diabetes (T.R.C., R.E., A.Ka., A.Ko., P.J.L., C.A., T.H.), Integrated Drug Discovery (M.M.), Biomarkers and Clinical Bioanalysis (U.S.), Translational In Vivo Models, Global Discovery Pathology (P.S.), and Global Research Project Management (M.F.), Sanofi-Aventis Deutschland GmbH, Industriepark Höchst, Frankfurt, Germany; C&BD Haverhill Operations, Sanofi GB Genzyme Limited, Haverhill, Suffolk, United Kingdom (I.D.); R&D Translational Sciences France, Bioinformatics, Sanofi, Chilly-Mazarin Cedex, France (C.R.); Translational In Vivo Models, Global Discovery Pathology, Framingham, Massachusetts (K.S., D.S.B.); and Pharmaceutical Development Platform, Sanofi Global R&D, Waltham, Massachusetts (P.K.D.)
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Abstract

As a gut-restricted, nonabsorbed therapy, polymeric bile acid sequestrants (BAS) play an important role in managing hyperlipidemia and hyperglycemia. Similarly, nonabsorbable sequestrants of dietary phosphate have been used for the management of hyperphosphatemia in end-stage renal disease. To evaluate the potential utility of such polymer sequestrants to treat type 2 diabetes (T2D) and its associated renal and cardiovascular complications, we synthesized a novel polymeric sequestrant, SAR442357, possessing optimized bile acid (BA) and phosphate sequestration characteristics. Long-term treatment of T2D obese cZucker fatty/Spontaneously hypertensive heart failure F1 hybrid (ZSF1) with SAR442357 resulted in enhanced sequestration of BAs and phosphate in the gut, improved glycemic control, lowering of serum cholesterol, and attenuation of diabetic kidney disease (DKD) progression. In comparison, colesevelam, a BAS with poor phosphate binding properties, did not prevent DKD progression, whereas losartan, an angiotensin II receptor blocker that is widely used to treat DKD, showed no effect on hyperglycemia. Analysis of hepatic gene expression levels of the animals treated with SAR442357 revealed upregulation of genes responsible for the biosynthesis of cholesterol and BAs, providing clear evidence of target engagement and mode of action of the new sequestrant. Additional hepatic gene expression pathway changes were indicative of an interruption of the enterohepatic BA cycle. Histopathological analysis of ZSF1 rat kidneys treated with SAR442357 further supported its nephroprotective properties. Collectively, these findings reveal the pharmacological benefit of simultaneous sequestration of BAs and phosphate in treating T2D and its associated comorbidities and cardiovascular complications.

SIGNIFICANCE STATEMENT A new nonabsorbed polymeric sequestrant with optimum phosphate and bile salt sequestration properties was developed as a treatment option for DKD. The new polymeric sequestrant offered combined pharmacological benefits including glucose regulation, lipid lowering, and attenuation of DKD progression in a single therapeutic agent.

Footnotes

    • Received August 14, 2020.
    • Accepted November 10, 2020.
  • ↵1 Current affiliation: WuXi AppTec Inc., Cambridge, Massachusetts.

  • ↵2 Current affiliation: Fraunhofer IME, Translational Medicine and Pharmacology, Frankfurt, Germany.

  • ↵3 Current affiliation: Eli Lilly and Company, Indianapolis, Indiana.

  • ↵4 Current affiliation: Bayer AG, Pharmaceutical R&D, Wuppertal, Germany.

  • This work received no external funding.

  • All authors are current or former employees of Sanofi. No author has an actual or perceived conflict of interest with the contents of this article.

  • https://doi.org/10.1124/jpet.120.000285.

  • ↵Embedded ImageThis article has supplemental material available at jpet.aspetjournals.org.

  • Copyright © 2021 by The American Society for Pharmacology and Experimental Therapeutics
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Journal of Pharmacology and Experimental Therapeutics: 376 (2)
Journal of Pharmacology and Experimental Therapeutics
Vol. 376, Issue 2
1 Feb 2021
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Research ArticleEndocrine and Diabetes

A Novel Polymeric Sequestrant Delays Diabetic Nephropathy

Tamara R. Castañeda, María Méndez, Ian Davison, Ralf Elvert, Uwe Schwahn, Galina Boldina, Corinne Rocher, Petra Scherer, Kuldeep Singh, Dinesh S. Bangari, Mechthilde Falkenhahn, Aimo Kannt, Anish Konkar, Philip J. Larsen, Cynthia Arbeeny, Pradeep K. Dhal and Thomas Hübschle
Journal of Pharmacology and Experimental Therapeutics February 1, 2021, 376 (2) 190-203; DOI: https://doi.org/10.1124/jpet.120.000285

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Research ArticleEndocrine and Diabetes

A Novel Polymeric Sequestrant Delays Diabetic Nephropathy

Tamara R. Castañeda, María Méndez, Ian Davison, Ralf Elvert, Uwe Schwahn, Galina Boldina, Corinne Rocher, Petra Scherer, Kuldeep Singh, Dinesh S. Bangari, Mechthilde Falkenhahn, Aimo Kannt, Anish Konkar, Philip J. Larsen, Cynthia Arbeeny, Pradeep K. Dhal and Thomas Hübschle
Journal of Pharmacology and Experimental Therapeutics February 1, 2021, 376 (2) 190-203; DOI: https://doi.org/10.1124/jpet.120.000285
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