A mechanistic pharmacokinetic/pharmacodynamic model of factor D inhibition in cynomolgus monkeys by lampalizumab for the treatment of geographic atrophy

Journal of Pharmacology and Experimental Therapeutics

Volumn 355, Issue 2, 2015, Pages 288-296

  Le, Kha N ^a   Gibiansky, Leonid ^b   Good, Jeremy ^a   Davancaze, Teresa ^a   Van Lookeren Campagne, Menno ^a   Loyet, Kelly M ^a   Morimoto, Alyssa ^a   Jin, Jin ^a   Damico Beyer, Lisa A ^a   Hanley, William D ^a  

^a GENENTECH INC   (United States)

^b QuantPharm LLC 49 Flints Grove Drive   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

COMPLEMENT FACTOR D; LAMPALIZUMAB; IMMUNOGLOBULIN F(AB) FRAGMENT; MONOCLONAL ANTIBODY;

ANIMAL EXPERIMENT; ANIMAL MODEL; ANIMAL TISSUE; ARTICLE; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DISPOSITION; DRUG DISTRIBUTION; DRUG ELIMINATION; ENZYME INHIBITION; ENZYME SYNTHESIS; FEMALE; GEOGRAPHIC ATROPHY; MACACA FASCICULARIS; MALE; NONHUMAN; OCULAR TISSUE; PHARMACODYNAMICS; PHASE 2 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; SIMULATION; SINGLE DRUG DOSE; SYSTEMIC CIRCULATION; VISUAL SYSTEM PARAMETERS; ANIMAL; ANTAGONISTS AND INHIBITORS; AQUEOUS HUMOR; BIOLOGICAL MODEL; INTRAVENOUS DRUG ADMINISTRATION; INTRAVITREAL DRUG ADMINISTRATION; METABOLISM; RETINA; VITREOUS BODY;

ADMINISTRATION, INTRAVENOUS; ANIMALS; ANTIBODIES, MONOCLONAL, HUMANIZED; AQUEOUS HUMOR; COMPLEMENT FACTOR D; FEMALE; GEOGRAPHIC ATROPHY; IMMUNOGLOBULIN FAB FRAGMENTS; INTRAVITREAL INJECTIONS; MACACA FASCICULARIS; MALE; MODELS, BIOLOGICAL; RETINA; VITREOUS BODY;

EID: 84946546178     PISSN: 00223565     EISSN: 15210103     Source Type: Journal    
DOI: 10.1124/jpet.115.227223     Document Type: Article

References (34)

1. Agoram BM, Martin SW, and van der Graaf PH (2007) The role of mechanism-based pharmacokinetic-pharmacodynamic (PK-PD) modelling in translational research of biologics. Drug Discov Today 12:1018-1024.
2. Anderson DH, Radeke MJ, Gallo NB, Chapin EA, Johnson PT, Curletti CR, Hancox LS, Hu J, Ebright JN, and Malek G, et al. (2010) The pivotal role of the complement system in aging and age-related macular degeneration: hypothesis re-visited. Prog Retin Eye Res 29:95-112.
3. Barnum SR, Niemann MA, Kearney JF, and Volanakis JE (1984) Quantitation of complement factor D in human serum by a solid-phase radioimmunoassay. J Immunol Methods 67:303-309.
4. Davda JP and Hansen RJ (2010) Properties of a general PK/PD model of antibodyligand interactions for therapeutic antibodies that bind to soluble endogenous targets. MAbs 2:576-588.
5. de Jong PT (2006) Age-related macular degeneration. N Engl J Med 355:1474-1485.
6. Deng R, Iyer S, Theil FP, Mortensen DL, Fielder PJ, and Prabhu S (2011) Projecting human pharmacokinetics of therapeutic antibodies from nonclinical data: what have we learned? MAbs 3:61-66.
7. Do DV, Pieramici DJ, van Lookeren Campagne M, Beres T, Friesenhahn M, Zhang Y, and Strauss EC; Phase Ia Investigators (2014) A phase ia dose-escalation study of the anti-factor D monoclonal antibody fragment FCFD4514S in patients with geographic atrophy. Retina 34:313-320.
8. Fritsche LG, Chen W, Schu M, Yaspan BL, Yu Y, Thorleifsson G, Zack DJ, Arakawa S, Cipriani V, and Ripke S, et al. (2013) Seven new loci associated with age-related macular degeneration. Nat Genet 45:433-439, 439e1-439e2.
9. Gaudreault J, Fei D, Rusit J, Suboc P, and Shiu V (2005) Preclinical pharmacokinetics of Ranibizumab (rhuFabV2) after a single intravitreal administration. Invest Ophthalmol Vis Sci 46:726-733.
10. Gibiansky L, Gibiansky E, Kakkar T, and Ma P (2008) Approximations of the targetmediated drug disposition model and identifiability of model parameters. J Pharmacokinet Pharmacodyn 35:573-591.
11. Girmens JF, Sahel JA, and Marazova K (2012) Dry age-related macular degeneration: A currently unmet clinical need. Intractable Rare Dis Res 1:103-114.
12. Hayashi N, Tsukamoto Y, Sallas WM, and Lowe PJ (2007) A mechanism-based binding model for the population pharmacokinetics and pharmacodynamics of omalizumab. Br J Clin Pharmacol 63:548-561.
13. Hecker LA, Edwards AO, Ryu E, Tosakulwong N, Baratz KH, Brown WL, Charbel Issa P, Scholl HP, Pollok-Kopp B, and Schmid-Kubista KE, et al. (2010) Genetic control of the alternative pathway of complement in humans and age-related macular degeneration. Hum Mol Genet 19:209-215.
14. Kang-Mieler JJ, Osswald CR, and Mieler WF (2014) Advances in ocular drug delivery: emphasis on the posterior segment. Expert Opin Drug Deliv 11:1647-1660.
15. Katschke KJ Jr, Wu P, Ganesan R, Kelley RF, Mathieu MA, Hass PE, Murray J, Kirchhofer D, Wiesmann C, and van Lookeren Campagne M (2012) Inhibiting alternative pathway complement activation by targeting the factor D exosite. J Biol Chem 287:12886-12892.
16. Krohne TU, Liu Z, Holz FG, and Meyer CH (2012) Intraocular pharmacokinetics of ranibizumab following a single intravitreal injection in humans. Am J Ophthalmol 154:682-686.e2.
17. Le KN, Gibiansky L, van Lookeren Campagne M, Good J, Davancaze T, Loyet KM, Morimoto A, Strauss EC, and Jin JY (2015) Population pharmacokinetics and pharmacodynamics of lampalizumab administered intravitreally to patients with geographic atrophy. CPT Pharmacometrics Syst Pharmacol, in press.
18. Loyet KM, Deforge LE, Katschke KJ Jr, Diehl L, Graham RR, Pao L, Sturgeon L, Lewin-Koh SC, Hollyfield JG, and van Lookeren Campagne M (2012) Activation of the alternative complement pathway in vitreous is controlled by genetics in agerelated macular degeneration. Invest Ophthalmol Vis Sci 53:6628-6637.
19. Loyet KM, Good J, Davancaze T, Sturgeon L, Wang X, Yang J, Le KN, Wong M, Hass PE, and van Lookeren Campagne M, et al. (2014) Complement inhibition in cynomolgus monkeys by anti-factor d antigen-binding fragment for the treatment of an advanced form of dry age-related macular degeneration. J Pharmacol Exp Ther 351:527-537.
20. Luu KT, Kraynov E, Kuang B, Vicini P, and Zhong WZ (2013) Modeling, simulation, and translation framework for the preclinical development of monoclonal antibodies. AAPS J 15:551-558.
21. Macugen. (2011) Package insert. Eyetech, Inc., Palm Beach Gardens, FL.
22. Mager DE (2006) Target-mediated drug disposition and dynamics. Biochem Pharmacol 72:1-10.
23. Mager DE and Jusko WJ (2001) General pharmacokinetic model for drugs exhibiting target-mediated drug disposition. J Pharmacokinet Pharmacodyn 28:507-532.
24. Pascual M, Steiger G, Estreicher J, Macon K, Volanakis JE, and Schifferli JA (1988) Metabolism of complement factor D in renal failure. Kidney Int 34:529-536.
25. Rees A, Zekite A, Bunce C, and Patel PJ (2014) How many people in England and Wales are registered partially sighted or blind because of age-related macular degeneration? Eye (Lond) 28:832-837.
26. Scholl HP, Charbel Issa P, Walier M, Janzer S, Pollok-Kopp B, Börncke F, Fritsche LG, Chong NV, Fimmers R, and Wienker T, et al. (2008) Systemic complement activation in age-related macular degeneration. PLoS One 3:e2593.
27. Schuck E, Bohnert T, Chakravarty A, Damian-Iordache V, Gibson C, Hsu CP, Heimbach T, Krishnatry AS, Liederer BM, and Lin J, et al. (2015) Preclinical pharmacokinetic/pharmacodynamic modeling and simulation in the pharmaceutical industry: An IQ consortium survey examining the current landscape. AAPS J 17:462-473.
28. Stanton CM, Yates JR, den Hollander AI, Seddon JM, Swaroop A, Stambolian D, Fauser S, Hoyng C, Yu Y, and Atsuhiro K, et al. (2011) Complement factor D in age-related macular degeneration. Invest Ophthalmol Vis Sci 52:8828-8834.
29. Struble C, Howard S, and Relph J (2014) Comparison of ocular tissue weights (volumes) and tissue collection techniques in commonly used preclinical animal species, in The European Association for Vision and Eye Research (EVER); 2014 Oct 1-4; Nice, France.
30. Sunness JS, Rubin GS, Applegate CA, Bressler NM, Marsh MJ, Hawkins BS, and Haselwood D (1997) Visual function abnormalities and prognosis in eyes with age-related geographic atrophy of the macula and good visual acuity. Ophthalmology 104:1677-1691.
31. United Kingdom Department of Health (2013) Certificate of vision impairment explanatory notes for consultant ophthalmologists and hospital eye clinic staff. https://www.gov.uk/government/uploads/system/uploads/attachment-data/file2132/CVI-Explanatory-notes-in-DH-template.pdf. Accessed September 23, 2015.
32. Van Der Graaf PH and Gabrielsson J (2009) Pharmacokinetic-pharmacodynamic reasoning in drug discovery and early development. Future Med Chem 1: 1371-1374.
33. Wong WL, Su X, Li X, Cheung CM, Klein R, Cheng CY, and Wong TY (2014) Global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040: A systematic review and meta-analysis. Lancet Glob Health 2: e106-e116.
34. Xu L, Lu T, Tuomi L, Jumbe N, Lu J, Eppler S, Kuebler P, Damico-Beyer LA, and Joshi A (2013) Pharmacokinetics of ranibizumab in patients with neovascular age-related macular degeneration: A population approach. Invest Ophthalmol Vis Sci 54:1616-1624.