Inhaled mosliciguat (BAY 1237592): targeting pulmonary vasculature via activating apo-sGC.


Journal

Respiratory research
ISSN: 1465-993X
Titre abrégé: Respir Res
Pays: England
ID NLM: 101090633

Informations de publication

Date de publication:
01 Oct 2022
Historique:
received: 06 05 2022
accepted: 16 09 2022
entrez: 1 10 2022
pubmed: 2 10 2022
medline: 5 10 2022
Statut: epublish

Résumé

Oxidative stress associated with severe cardiopulmonary diseases leads to impairment in the nitric oxide/soluble guanylate cyclase signaling pathway, shifting native soluble guanylate cyclase toward heme-free apo-soluble guanylate cyclase. Here we describe a new inhaled soluble guanylate cyclase activator to target apo-soluble guanylate cyclase and outline its therapeutic potential. We aimed to generate a novel soluble guanylate cyclase activator, specifically designed for local inhaled application in the lung. We report the discovery and in vitro and in vivo characterization of the soluble guanylate cyclase activator mosliciguat (BAY 1237592). Mosliciguat specifically activates apo-soluble guanylate cyclase leading to improved cardiopulmonary circulation. Lung-selective effects, e.g., reduced pulmonary artery pressure without reduced systemic artery pressure, were seen after inhaled but not after intravenous administration in a thromboxane-induced pulmonary hypertension minipig model. These effects were observed over a broad dose range with a long duration of action and were further enhanced under experimental oxidative stress conditions. In a unilateral broncho-occlusion minipig model, inhaled mosliciguat decreased pulmonary arterial pressure without ventilation/perfusion mismatch. With respect to airway resistance, mosliciguat showed additional beneficial bronchodilatory effects in an acetylcholine-induced rat model. Inhaled mosliciguat may overcome treatment limitations in patients with pulmonary hypertension by improving pulmonary circulation and airway resistance without systemic exposure or ventilation/perfusion mismatch. Mosliciguat has the potential to become a new therapeutic paradigm, exhibiting a unique mode of action and route of application, and is currently under clinical development in phase Ib for pulmonary hypertension.

Sections du résumé

BACKGROUND BACKGROUND
Oxidative stress associated with severe cardiopulmonary diseases leads to impairment in the nitric oxide/soluble guanylate cyclase signaling pathway, shifting native soluble guanylate cyclase toward heme-free apo-soluble guanylate cyclase. Here we describe a new inhaled soluble guanylate cyclase activator to target apo-soluble guanylate cyclase and outline its therapeutic potential.
METHODS METHODS
We aimed to generate a novel soluble guanylate cyclase activator, specifically designed for local inhaled application in the lung. We report the discovery and in vitro and in vivo characterization of the soluble guanylate cyclase activator mosliciguat (BAY 1237592).
RESULTS RESULTS
Mosliciguat specifically activates apo-soluble guanylate cyclase leading to improved cardiopulmonary circulation. Lung-selective effects, e.g., reduced pulmonary artery pressure without reduced systemic artery pressure, were seen after inhaled but not after intravenous administration in a thromboxane-induced pulmonary hypertension minipig model. These effects were observed over a broad dose range with a long duration of action and were further enhanced under experimental oxidative stress conditions. In a unilateral broncho-occlusion minipig model, inhaled mosliciguat decreased pulmonary arterial pressure without ventilation/perfusion mismatch. With respect to airway resistance, mosliciguat showed additional beneficial bronchodilatory effects in an acetylcholine-induced rat model.
CONCLUSION CONCLUSIONS
Inhaled mosliciguat may overcome treatment limitations in patients with pulmonary hypertension by improving pulmonary circulation and airway resistance without systemic exposure or ventilation/perfusion mismatch. Mosliciguat has the potential to become a new therapeutic paradigm, exhibiting a unique mode of action and route of application, and is currently under clinical development in phase Ib for pulmonary hypertension.

Identifiants

pubmed: 36183104
doi: 10.1186/s12931-022-02189-1
pii: 10.1186/s12931-022-02189-1
pmc: PMC9526466
doi:

Substances chimiques

Thromboxanes 0
Vasodilator Agents 0
Nitric Oxide 31C4KY9ESH
Guanylate Cyclase EC 4.6.1.2
Soluble Guanylyl Cyclase EC 4.6.1.2
Acetylcholine N9YNS0M02X

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

272

Informations de copyright

© 2022. The Author(s).

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Auteurs

Eva M Becker-Pelster (EM)

Pharmaceuticals R&D, Pharma Research Center, Bayer AG, Aprather Weg 18A, 42113, Wuppertal, Germany. eva.becker-pelster@bayer.com.

Michael G Hahn (MG)

Pharmaceuticals R&D, Pharma Research Center, Bayer AG, Aprather Weg 18A, 42113, Wuppertal, Germany.

Martina Delbeck (M)

Pharmaceuticals R&D, Pharma Research Center, Bayer AG, Aprather Weg 18A, 42113, Wuppertal, Germany.

Lisa Dietz (L)

Pharmaceuticals R&D, Pharma Research Center, Bayer AG, Aprather Weg 18A, 42113, Wuppertal, Germany.

Jörg Hüser (J)

Pharmaceuticals R&D, Pharma Research Center, Bayer AG, Aprather Weg 18A, 42113, Wuppertal, Germany.

Johannes Kopf (J)

Pharmaceuticals R&D, Pharma Research Center, Bayer AG, Aprather Weg 18A, 42113, Wuppertal, Germany.

Thomas Kraemer (T)

Pharmaceuticals R&D, Pharma Research Center, Bayer AG, Aprather Weg 18A, 42113, Wuppertal, Germany.

Tobias Marquardt (T)

Pharmaceuticals R&D, Pharma Research Center, Bayer AG, Aprather Weg 18A, 42113, Wuppertal, Germany.

Thomas Mondritzki (T)

Pharmaceuticals R&D, Pharma Research Center, Bayer AG, Aprather Weg 18A, 42113, Wuppertal, Germany.
Fakultät für Gesundheit, University Witten/Herdecke, Witten, Germany.

Johannes Nagelschmitz (J)

Pharmaceuticals R&D, Pharma Research Center, Bayer AG, Aprather Weg 18A, 42113, Wuppertal, Germany.

Sylvia M Nikkho (SM)

Pharmaceuticals R&D, Pharma Research Center, Bayer AG, Aprather Weg 18A, 42113, Wuppertal, Germany.

Philippe V Pires (PV)

The Janssen Pharmaceutical Companies of Johnson & Johnson, Allschwil, Switzerland.

Hanna Tinel (H)

Pharmaceuticals R&D, Pharma Research Center, Bayer AG, Aprather Weg 18A, 42113, Wuppertal, Germany.

Gerrit Weimann (G)

Pharmaceuticals R&D, Pharma Research Center, Bayer AG, Aprather Weg 18A, 42113, Wuppertal, Germany.

Frank Wunder (F)

Pharmaceuticals R&D, Pharma Research Center, Bayer AG, Aprather Weg 18A, 42113, Wuppertal, Germany.

Peter Sandner (P)

Pharmaceuticals R&D, Pharma Research Center, Bayer AG, Aprather Weg 18A, 42113, Wuppertal, Germany.
Department of Pharmacology, Hannover Medical School, Hannover, Germany.

Joachim Schuhmacher (J)

Pharmaceuticals R&D, Pharma Research Center, Bayer AG, Aprather Weg 18A, 42113, Wuppertal, Germany.

Johannes-Peter Stasch (JP)

Pharmaceuticals R&D, Pharma Research Center, Bayer AG, Aprather Weg 18A, 42113, Wuppertal, Germany.
Institute of Pharmacy, University Halle-Wittenberg, Halle, Germany.

Hubert K F Truebel (HKF)

The Knowledge House, Breite Strasse 22, Düsseldorf, Germany.

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