Vicore Pharma Holding has announced plans to initiate a clinical trial with C21 in Pulmonary arterial hypertension.
Pulmonary arterial hypertension (PAH) is a rare lung disease with huge unmet medical need where existing medicines reduce the pressure by dilating the vessels without changing underlying disease or survival, describes the company. Both PAH and the pulmonary hypertension associated with idiopathic pulmonary fibrosis come with pulmonary vascular dysfunction contributing to progression of disease and finally cardiac failure.
“We have been investigating PAH as a possible indication for development before, and now with the preclinical data at hand as well as the strong interim data in IPF, we decided to progress C21 to a proof-of-concept trial strengthening our rare lung disease portfolio,” says Carl-Johan Dalsgaard, CEO of Vicore.
Vicore has generated preclinical data in pulmonary hypertension models showing that C21 reverses vascular remodelling and significantly improves hemodynamics. In combination with the vascular effects demonstrated in the mechanistic clinical trial in systemic sclerosis patients, the data supports clinical development in PAH. C21 reduces the pro-fibrotic factor TGFβ in human IPF lung tissue and the established role of TGFβ in the development of PAH further strengthens the hypothesis. If development is successful, C21 would likely enjoy orphan drug status protection in the US and in Europe, states the company.
Photo of Carl-Johan Dalsgaard: Vicore Pharma