A CGRP receptor antagonist peptide formulated for nasal administration to treat migraine

J Pharm Pharmacol. 2020 Oct;72(10):1352-1360. doi: 10.1111/jphp.13317. Epub 2020 Jun 25.

Abstract

Objectives: To investigate the formulation of the peptide-based antagonist (34 Pro,35 Phe)CGRP27-37 , of the human calcitonin gene-related peptide (CGRP) receptor as a potential nasally delivered migraine treatment.

Methods: Peptide sequences were prepared using automated methods and purified by preparative HPLC. Their structure and stability were determined by LC-MS. Antagonist potency was assessed by measuring CGRP-stimulated cAMP accumulation in SK-N-MC, cells and in CHO cells overexpressing the human CGRP receptor. In vivo activity was tested in plasma protein extravasation (PPE) studies using Evans blue dye accumulation. Peptide-containing chitosan microparticles were prepared by spray drying.

Key findings: (34 Pro,35 Phe)CGRP27-37 exhibited a 10-fold increased affinity compared to αCGRP27-37 . Administration of (34 Pro,35 Phe)CGRP27-37 to mice led to a significant decrease in CGRP-induced PPE confirming antagonistic properties in vivo. There was no degradation of (34 Pro,35 Phe)CGRP27-37 and no loss of antagonist potency during formulation and release from chitosan microparticles.

Conclusions: (34 Pro,35 Phe)CGRP27-37 is a potent CGRP receptor antagonist both in vitro and in vivo, and it can be formulated as a dry powder with no loss of activity indicating its potential as a nasally formulated anti-migraine medicine.

Keywords: SK-N-MC; aCGRP (27-37); aCGRP (8-37); cAMP; plasma extravasation.

MeSH terms

  • Administration, Intranasal
  • Animals
  • CHO Cells
  • Calcitonin Gene-Related Peptide Receptor Antagonists / administration & dosage*
  • Calcitonin Gene-Related Peptide Receptor Antagonists / chemical synthesis
  • Calcitonin Gene-Related Peptide Receptor Antagonists / metabolism*
  • Cell Line, Tumor
  • Cricetinae
  • Cricetulus
  • Dose-Response Relationship, Drug
  • Drug Compounding / methods*
  • Mice
  • Mice, Inbred C57BL
  • Migraine Disorders / drug therapy*
  • Migraine Disorders / metabolism*
  • Receptors, Calcitonin Gene-Related Peptide / metabolism*

Substances

  • Calcitonin Gene-Related Peptide Receptor Antagonists
  • Receptors, Calcitonin Gene-Related Peptide