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Recombinant human pentraxin-2 therapy in patients with idiopathic pulmonary fibrosis: safety, pharmacokinetics and exploratory efficacy.

Publication ,  Journal Article
van den Blink, B; Dillingh, MR; Ginns, LC; Morrison, LD; Moerland, M; Wijsenbeek, M; Trehu, EG; Bartholmai, BJ; Burggraaf, J
Published in: Eur Respir J
March 2016

Abnormal fibrogenic repair response upon alveolar injury is believed to play an important role in the pathogenesis of idiopathic pulmonary fibrosis (IPF). PRM-151 (recombinant human pentraxin-2, also known as serum amyloid P), has been shown to reduce fibrosis in preclinical lung fibrosis models, and was well tolerated with a favourable pharmacokinetic profile in an earlier single-dose phase I study.A randomised, double-blind, placebo-controlled, multiple ascending dose trial was performed to assess the tolerability and pharmacokinetic and pharmacodynamic characteristics of multiple doses of PRM-151 in IPF patients. Subjects in three successive cohorts (1, 5, or 10 mg·kg(-1) versus placebo) received intravenous study drug on days 1, 3, 5, 8 and 15, and were followed-up to day 57.PRM-151 was well tolerated at all dose levels, with no serious adverse reactions. Administration of PRM-151 resulted in two- to eight-fold dose-dependent increases in circulating pentraxin-2 levels. Forced vital capacity and 6-min walk test showed trends towards improvement in the combined PRM-151 dose groups. On high-resolution computed tomography scans, stable or improved lung volume unoccupied by interstitial lung abnormality was noted in some PRM-151 subjects compared to placebo subjects on day 57.The efficacy of PRM-151 in IPF remains to be investigated in dedicated future trials.

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Published In

Eur Respir J

DOI

EISSN

1399-3003

Publication Date

March 2016

Volume

47

Issue

3

Start / End Page

889 / 897

Location

England

Related Subject Headings

  • United States
  • Treatment Outcome
  • Serum Amyloid P-Component
  • Respiratory System
  • Respiratory Function Tests
  • Recombinant Proteins
  • Netherlands
  • Middle Aged
  • Male
  • Lung
 

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van den Blink, B., Dillingh, M. R., Ginns, L. C., Morrison, L. D., Moerland, M., Wijsenbeek, M., … Burggraaf, J. (2016). Recombinant human pentraxin-2 therapy in patients with idiopathic pulmonary fibrosis: safety, pharmacokinetics and exploratory efficacy. Eur Respir J, 47(3), 889–897. https://doi.org/10.1183/13993003.00850-2015
Blink, Bernt van den, Marlous R. Dillingh, Leo C. Ginns, Lake D. Morrison, Matthijs Moerland, Marlies Wijsenbeek, Elizabeth G. Trehu, Brian J. Bartholmai, and Jacobus Burggraaf. “Recombinant human pentraxin-2 therapy in patients with idiopathic pulmonary fibrosis: safety, pharmacokinetics and exploratory efficacy.Eur Respir J 47, no. 3 (March 2016): 889–97. https://doi.org/10.1183/13993003.00850-2015.
van den Blink B, Dillingh MR, Ginns LC, Morrison LD, Moerland M, Wijsenbeek M, et al. Recombinant human pentraxin-2 therapy in patients with idiopathic pulmonary fibrosis: safety, pharmacokinetics and exploratory efficacy. Eur Respir J. 2016 Mar;47(3):889–97.
van den Blink, Bernt, et al. “Recombinant human pentraxin-2 therapy in patients with idiopathic pulmonary fibrosis: safety, pharmacokinetics and exploratory efficacy.Eur Respir J, vol. 47, no. 3, Mar. 2016, pp. 889–97. Pubmed, doi:10.1183/13993003.00850-2015.
van den Blink B, Dillingh MR, Ginns LC, Morrison LD, Moerland M, Wijsenbeek M, Trehu EG, Bartholmai BJ, Burggraaf J. Recombinant human pentraxin-2 therapy in patients with idiopathic pulmonary fibrosis: safety, pharmacokinetics and exploratory efficacy. Eur Respir J. 2016 Mar;47(3):889–897.
Journal cover image

Published In

Eur Respir J

DOI

EISSN

1399-3003

Publication Date

March 2016

Volume

47

Issue

3

Start / End Page

889 / 897

Location

England

Related Subject Headings

  • United States
  • Treatment Outcome
  • Serum Amyloid P-Component
  • Respiratory System
  • Respiratory Function Tests
  • Recombinant Proteins
  • Netherlands
  • Middle Aged
  • Male
  • Lung