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J Clin Med. 2019 Dec 24;9(1). pii: E41. doi: 10.3390/jcm9010041.

Safety of P28GST, a Protein Derived from a Schistosome Helminth Parasite, in Patients with Crohn's Disease: A Pilot Study (ACROHNEM).

Author information

1
U995-LIRIC, Lille Inflammation Research International Center, Univ. Lille, Inserm, CHU Lille, F-59000 Lille, France.
2
CIC 1403, Centre d'Investigation Clinique, Univ. Lille, Inserm, CHU Lille, F-59000 Lille, France.
3
Direction de la Recherche et de l'Innovation, CHU Lille, F-59000 Lille, France.
4
EA 2694-Santé Publique: épidémiologie et Qualité des Soins, Univ. Lille, CHU Lille, F-59000 Lille, France.
5
Par'Immune, Eurasante, F-59120 Loos lez Lille, France.
6
Service des Maladies de l'Appareil Digestif, Unité de Recherche Clinique, Centre Hospitalier de Valenciennes, F-59300 Valenciennes, France.
7
Service d'Hépato-Gastro-Entérologie, CHU Amiens Picardie, F-80054 Amiens, France.
8
Service d'Hépato-Gastro-Entérologie, Unité de Recherche Clinique, Centre Hospitalier de Dunkerque, F-59385 Dunkerque, France.
9
Service d'Hépato-Gastro-Entérologie, Unité de Recherche Clinique, Centre Hospitalier de Boulogne sur Mer, F-62200 Boulogne Sur Mer, France.
10
Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA.

Abstract

Despite the development of novel therapies, inflammatory bowel diseases remain an innovative treatment challenge. Helminth therapy is a new promising approach, and a key issue is the identification of helminth-derived anti-inflammatory mediators. P28 glutathione-S-transferase (P28GST), a protein derived from schistosomes, a trematode parasitic helminth, was shown to reduce intestinal inflammation in experimental colitis by down-regulating the Th1/Th17 response. In this multicenter, open-label, pilot Phase 2a study, we evaluated the safety of P28GST administered to patients with mild Crohn's disease (CD). We enrolled 10 patients with a baseline Crohn's disease activity index (CDAI) value <220. Eight patients received two to three subcutaneous injections of recombinant P28GST with adjuvant. This three-month treatment was followed by a nine-month monitoring period. The primary endpoints were the monthly rate and seriousness of adverse events (AEs). Secondary endpoints were clinical recurrence, assessed with the CDAI as well as the levels of immunologic and inflammatory blood and tissue markers. The most common AEs were local or regional events at the injection site and gastrointestinal disorders. At three months after the first injection, CDAI scores and blood calprotectin levels decreased in parallel. These results indicate that P28GST showed promise as a safe and new therapeutic option for treating CD.

KEYWORDS:

Crohn’s disease; Crohn’s disease activity index; P28GST; calprotectin; helminth protein; safety

PMID:
31878146
DOI:
10.3390/jcm9010041
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