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news.Bayer has started an international, multicentre, single-arm, open-label Phase III trial (PATENT-CHILD) to evaluate the safety and tolerability of riociguat in children suffering from pulmonary arterial hypertension (PAH).
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Riociguat, a soluble guanylate cyclase (sGC) stimulator, has been approved since 2013 for the treatment of adults suffering from this life-threatening disorder of the lungs.
The development and commercialization of riociguat is part of Bayer’s strategic collaboration with Merck in the field of soluble guanylate cyclase (sGC) modulation.
Bayer HealthCare Executive Committee member and Global Development head Dr Joerg Moeller said: "Taking into account the poor prognosis for children with pulmonary arterial hypertension, new medications are needed.
"In clinical studies riociguat has proven to be effective and well tolerated for adults, and now with our new study we will investigate its safety profile in children suffering from pulmonary hypertension."
The trial will evaluate the safety, tolerability and pharmacokinetics of a body-weight adjusted riociguat regimen in children aged between six years and less than 18 years of age who have been diagnosed with idiopathic PAH, hereditary PAH, or PAH associated with connective tissue disease or congenital heart disease with shunt closure.
Riociguat is the first member of a distinct class of compounds discovered and developed by Bayer as an oral treatment to target a key molecular mechanism underlying PH.
In October 2013, riociguat was approved in the US under the name Adempas for use in inoperable chronic thromboembolic pulmonary hypertension (CTEPH) or persistent or recurrent CTEPH after surgery and in PAH.
In March 2014, riociguat has been granted orphan drug designation In the EU and US, while it was also approved by the European Medicines Agency (EMA) under the name Adempas for use in CTEPH and PAH.
In Japan, the drug has been granted orphan drug designation in the CTEPH indication and was approved in CTEPH in January 2014 and in PAH in February 2015.